Viewing Study NCT04418661

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Ignite Creation Date: 2025-12-24 @ 12:18 PM
Ignite Modification Date: 2025-12-27 @ 10:43 PM
Study NCT ID: NCT04418661
Status: TERMINATED
Last Update Posted: 2025-05-29
First Post: 2020-05-29
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands', 'Singapore']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'C000718190', 'term': 'adagrasib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi aventis recherche & développement'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated due to strategic reasons not related to safety.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).', 'description': 'Analysis was performed on safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1- SAR442720 140mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.", 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 6, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with PD-L1 TPS\\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 12, 'seriousNumAtRisk': 13, 'deathsNumAffected': 5, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.", 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 16, 'seriousNumAtRisk': 19, 'deathsNumAffected': 11, 'seriousNumAffected': 11}, {'id': 'EG004', 'title': 'Part 3A- SAR442720 100mg BIW + Adagrasib', 'description': "Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.", 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 4- SAR442720 200mg + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.", 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 7, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Disseminated Intravascular Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Haemolytic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Cardiac Ventricular Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Eyelid Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Visual Acuity Reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Dyschezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- SAR442720 140mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of IMP up to 30 days after the last dose; approximately 27 weeks', 'description': 'AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP.'}, {'type': 'PRIMARY', 'title': 'Parts 1 and 3A: Number of Participants With Treatment Related Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- SAR442720 140mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG002', 'title': 'Part 3A- SAR442720 100mg BIW + Adagrasib', 'description': "Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 (21 days)', 'description': "Potential DLTs were defined as the AEs that occurred during the first cycle (C) of treatment, considered by the investigator to be related to IMP, unless due to disease progression or to a cause obviously unrelated to IMP: Grade(G)\\>= 4 AEs, G3 neutropenia lasting \\>7 days or febrile neutropenia; G3 thrombocytopenia with clinically significant bleeding; any G\\>=3 immune-related AEs; G3 nonhematologic AEs; G3 aspartate transaminase, alanine transaminase, and/or total bilirubin elevations that persist \\>5 days; possible Hy's law case; G3 QT interval corrected using Fridericia's formula prolongation; retinal vein occlusion any grade; toxicity related to IMP leading to 50% or less dose intensity of SAR442720 and/or delay in initiation of C2 dosing of pembrolizumab by \\>15 days, in the absence of recovery to baseline or G \\<=1 AE. Potential DLT were reviewed by Sponsor and investigators to confirm them as DLTs.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT evaluable population consisted of participants who took at least 4 of the 6 planned doses of SAR442720 (Part-1 and Part-3A) and 28 of the 42 planned doses of adagrasib (Part-3A) in the first cycle of the treatment and completed the DLT observation period OR participants who had any DLT observed in the DLT observation period.'}, {'type': 'PRIMARY', 'title': 'Part 2: Percentage of Participants With Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with PD-L1 TPS\\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '49.5'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '22.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) determined by investigator per response evaluation criteria in solid tumors (RECIST) version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 millimeter (mm) OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The confidence interval (CI) was estimated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP.'}, {'type': 'PRIMARY', 'title': 'Part 3A: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3A- SAR442720 100mg BIW + Adagrasib', 'description': "Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of IMP up to 30 days after the last dose; approximately 7 weeks', 'description': 'AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP.'}, {'type': 'PRIMARY', 'title': 'Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4- SAR442720 200mg + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'Pre-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '0.5 hours post-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '207', 'spread': '376', 'groupId': 'OG000'}]}]}, {'title': '1 hours post-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '262', 'spread': '323', 'groupId': 'OG000'}]}]}, {'title': '2 hours post-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '342', 'spread': '324', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '488', 'spread': '200', 'groupId': 'OG000'}]}]}, {'title': '8 hours post-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '492', 'spread': '220', 'groupId': 'OG000'}]}]}, {'title': '24 hours post-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '272', 'spread': '94.9', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: C1 D8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.5', 'spread': '23.6', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: C1 D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.67', 'spread': '21.6', 'groupId': 'OG000'}]}]}, {'title': '0.5 hours post-dose: C1 D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '458', 'spread': '524', 'groupId': 'OG000'}]}]}, {'title': '1 hours post-dose: C1 D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '629', 'spread': '615', 'groupId': 'OG000'}]}]}, {'title': '2 hours post-dose: C1 D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '757', 'spread': '441', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose: C1 D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '649', 'spread': '267', 'groupId': 'OG000'}]}]}, {'title': '8 hours post-dose: C1 D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '540', 'spread': '226', 'groupId': 'OG000'}]}]}, {'title': '24 hours post-dose: C1 D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '342', 'spread': '127', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.50', 'spread': '16.7', 'groupId': 'OG000'}]}]}, {'title': '0.5 hours post-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '238', 'spread': '454', 'groupId': 'OG000'}]}]}, {'title': '1 hours post-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '408', 'spread': '414', 'groupId': 'OG000'}]}]}, {'title': '2 hours post-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '557', 'spread': '341', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '583', 'spread': '254', 'groupId': 'OG000'}]}]}, {'title': '8 hours post-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '463', 'spread': '168', 'groupId': 'OG000'}]}]}, {'title': '24 hours post-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '288', 'spread': '118', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: C6 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.3', 'spread': '21.8', 'groupId': 'OG000'}]}]}, {'title': 'End of treatment (Week 45)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.3', 'spread': '42.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on C1 D1, C1 D15, C2 D1; Pre-dose on C1 D8 and C6 D1; end of treatment (Week 45)', 'description': 'Plasma samples were collected at specified timepoints for pharmacokinetic (PK) analysis.', 'unitOfMeasure': 'nanogram per milliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose. Only those participants with data collected at specified timepoints are reported.'}, {'type': 'PRIMARY', 'title': 'Part 4: Area Under Curve From Zero to Last Concentration Timepoint (AUClast) for SAR442720 Tablets and Capsules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4- SAR442720 200mg Tablet + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'C1 D1 (Tablet/Fed)', 'categories': [{'measurements': [{'value': '9410', 'spread': '3310', 'groupId': 'OG000'}]}]}, {'title': 'C1 D15 (Tablet/Fasted)', 'categories': [{'measurements': [{'value': '10800', 'spread': '4290', 'groupId': 'OG000'}]}]}, {'title': 'C2D1 (Capsules/Fasted)', 'categories': [{'measurements': [{'value': '9800', 'spread': '3970', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2D1', 'description': 'Plasma samples were collected at specified timepoints to determine AUClast for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using non-compartmental analysis (NCA) method.', 'unitOfMeasure': 'hour*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population consisted of participants who completed all of C1 and C2D1 with meal information, full PK, and no dose reduction/missed doses on C1D1, C1D15 and C2D1.'}, {'type': 'PRIMARY', 'title': 'Part 4: Maximum Observed Plasma Concentration (Cmax) for SAR442720 Tablets and Capsules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4- SAR442720 200mg + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'C1D1 (Tablet/Fed)', 'categories': [{'measurements': [{'value': '637', 'spread': '220', 'groupId': 'OG000'}]}]}, {'title': 'C1D15 (Tablet/Fasted)', 'categories': [{'measurements': [{'value': '828', 'spread': '310', 'groupId': 'OG000'}]}]}, {'title': 'C2D1 (Capsules/Fasted)', 'categories': [{'measurements': [{'value': '658', 'spread': '326', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1', 'description': 'Plasma samples were collected at specified timepoints to determine Cmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population consisted of participants who completed all of C1 and C2D1 with meal information, full PK, and no dose reduction/missed doses on C1D1, C1D15 and C2D1.'}, {'type': 'SECONDARY', 'title': 'Part 1: Plasma Concentration of SAR442720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- SAR442720 140mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'Pre-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '332', 'spread': '208', 'groupId': 'OG000'}, {'value': '519', 'spread': '270', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '327', 'spread': '91.0', 'groupId': 'OG000'}, {'value': '335', 'spread': '91.0', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: C1 D8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.5', 'spread': '50.4', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: C1 D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '267', 'spread': '328', 'groupId': 'OG000'}, {'value': '37.1', 'spread': '25.7', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.4', 'spread': '5.40', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '24.8', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '516', 'spread': '145', 'groupId': 'OG000'}, {'value': '527', 'spread': '337', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '413', 'spread': '118', 'groupId': 'OG000'}, {'value': '409', 'spread': '205', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-dose: C2 D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '698', 'spread': '350', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: C6 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.9', 'spread': 'NA', 'comment': 'Standard deviation (SD) cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment (Week 22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.0', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}, {'value': '221', 'spread': '334', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 2, 8, hours post-dose on C1 D1 and C2D1; pre-dose C1D8, C1D15, and C6D1; 2 hours C2D2; and end of treatment (Week 22)', 'description': 'Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose. Only those participants with data collected at specified timepoints are reported.'}, {'type': 'SECONDARY', 'title': 'Part 2: Plasma Concentration of SAR442720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with PD-L1 TPS\\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'Pre-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '325', 'spread': '202', 'groupId': 'OG000'}, {'value': '385', 'spread': '285', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: C1 D8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106', 'spread': '154', 'groupId': 'OG000'}, {'value': '100', 'spread': '172', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: C1 D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '149', 'spread': '234', 'groupId': 'OG000'}, {'value': '85.1', 'spread': '81.4', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.3', 'spread': '50.8', 'groupId': 'OG000'}, {'value': '83.9', 'spread': '159', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '340', 'spread': '211', 'groupId': 'OG000'}, {'value': '442', 'spread': '369', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: C6 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.9', 'spread': '42.8', 'groupId': 'OG000'}, {'value': '50.1', 'spread': '16.8', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment (Week 104)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.3', 'spread': '39.0', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '33.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 2 hours post-dose C1D1 and C2D1; pre-dose on C1D8, C1D15, C6D1; and end of treatment (Week 104)', 'description': 'Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose. Only those participants with data collected at specified timepoints are reported.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Serum Concentration of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- SAR442720 140mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG002', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with PD-L1 TPS\\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG003', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'Pre-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}, {'title': 'Post-dose: C1 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83200', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}, {'value': '63600', 'spread': '11600', 'groupId': 'OG001'}, {'value': '85200', 'spread': '38100', 'groupId': 'OG002'}, {'value': '98900', 'spread': '55500', 'groupId': 'OG003'}]}]}, {'title': 'Pre-dose: C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15500', 'spread': '5350', 'groupId': 'OG000'}, {'value': '14400', 'spread': '5480', 'groupId': 'OG001'}, {'value': '10800', 'spread': '3520', 'groupId': 'OG002'}, {'value': '9290', 'spread': '3620', 'groupId': 'OG003'}]}]}, {'title': 'Pre-dose: C6 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '46000', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '23400', 'spread': '6450', 'groupId': 'OG002'}, {'value': '27200', 'spread': '6350', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and post-dose C1D1; pre-dose on C2D1 and C6D1', 'description': 'Serum samples were collected at specified timepoints for evaluation of pembrolizumab PK concentrations.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of participants who had at least 1 measurable pembrolizumab concentration after the first dose. Only those participants with data collected at specified timepoints are reported.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 4: Percentage of Participants With Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- SAR442720 140mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG002', 'title': 'Part 4- SAR442720 200mg + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '52.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '20.6'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '27.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks (Part 1), 46 weeks (Part 4)', 'description': 'ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP.'}, {'type': 'SECONDARY', 'title': 'Part 1: Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- SAR442720 140mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}], 'timeFrame': 'Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks', 'description': 'DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive disease progression(PD) or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP and with best overall response (BOR) at least PR. Only responders with BOR with at least a PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 2: Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with PD-L1 TPS\\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA indicates that the median, upper limit, and lower limit of CI were not estimable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.59', 'comment': 'NA indicates upper and lower limit of 90% CI was not estimable when only 1 participant was analyzed.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5mm. DoR was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP and with BOR at least PR. Only responders with BOR with at least a PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 2: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with PD-L1 TPS\\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of IMP up to 30 days after the last dose; approximately 111 weeks', 'description': 'AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP.'}, {'type': 'SECONDARY', 'title': 'Part 4: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4- SAR442720 200mg + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of IMP up to 30 days after the last dose; approximately 50 weeks', 'description': 'AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP.'}, {'type': 'SECONDARY', 'title': 'Part 2: Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with PD-L1 TPS\\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '2.23', 'comment': 'NA indicates that the upper limit of CI was not estimable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '2.103', 'upperLimit': 'NA'}, {'value': '4.34', 'comment': 'NA indicates upper and lower limit of 90% CI was not estimable when only 1 participant was analyzed.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'TTR was defined as the time interval from the administration of first IMP dose to the first documented evidence of PR or CR determined by the Investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. TTR was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP and with BOR at least PR. Only responders with BOR with at least a PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With Clinical Benefit Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with PD-L1 TPS\\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '57.3'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '41.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'Clinical benefit rate was defined as the percentage of participants with confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The CI was estimated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With Disease Control Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with PD-L1 TPS\\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '28.7', 'upperLimit': '77.6'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '53.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'Disease control rate was defined percentage of participants with confirmed CR or PR or SD as determined by the investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The CI was estimated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP.'}, {'type': 'SECONDARY', 'title': 'Part 2: Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with PD-L1 TPS\\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'OG001', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '3.38', 'groupId': 'OG000', 'lowerLimit': '1.084', 'upperLimit': '7.852'}, {'value': '1.95', 'groupId': 'OG001', 'lowerLimit': '1.117', 'upperLimit': '6.111'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'PFS was defined as the time from the date of first IMP administration to the date of the first documented PD determined by the investigator per RECIST version 1.1 or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. PFS was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP.'}, {'type': 'SECONDARY', 'title': 'Part 3A: Plasma Concentration of SAR442720', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3A- SAR442720 100mg BIW + Adagrasib', 'description': "Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'Pre-dose: C1 D1', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '0.5 hours post-dose: C1 D1', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '1 hours post-dose: C1 D1', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '2 hours post-dose: C1 D1', 'categories': [{'measurements': [{'value': '170', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose: C1 D1', 'categories': [{'measurements': [{'value': '432', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '6 hours post-dose: C1 D1', 'categories': [{'measurements': [{'value': '356', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '24 hours post-dose: C1 D1', 'categories': [{'measurements': [{'value': '167', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: C1 D8', 'categories': [{'measurements': [{'value': '31.5', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: C1 D15', 'categories': [{'measurements': [{'value': '36.6', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '0.5 hours post-dose: C1 D15', 'categories': [{'measurements': [{'value': '34.3', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '1 hours post-dose: C1 D15', 'categories': [{'measurements': [{'value': '46.6', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '2 hours post-dose: C1 D15', 'categories': [{'measurements': [{'value': '306', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose: C1 D15', 'categories': [{'measurements': [{'value': '376', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '6 hours post-dose: C1 D15', 'categories': [{'measurements': [{'value': '310', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'End of treatment (Week 3)', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post-dose C1D1; pre-dose C1D8; pre-dose, 0.5, 1, 2, 4, 6 post-dose C1D15, and end of treatment (Week 3)', 'description': 'Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations. It was calculated using NCA method.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose.'}, {'type': 'SECONDARY', 'title': 'Part 3A: Plasma Concentration of Adagrasib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3A- SAR442720 100mg BIW + Adagrasib', 'description': "Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'Pre-dose: C1 D1', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '1 hours post-dose: C1 D1', 'categories': [{'measurements': [{'value': '376', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '2 hours post-dose: C1 D1', 'categories': [{'measurements': [{'value': '727', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose: C1 D1', 'categories': [{'measurements': [{'value': '1560', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '6 hours post-dose: C1 D1', 'categories': [{'measurements': [{'value': '1330', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '8 hours post-dose: C1 D1', 'categories': [{'measurements': [{'value': '1180', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: C1 D8', 'categories': [{'measurements': [{'value': '2640', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: C1 D15', 'categories': [{'measurements': [{'value': '2110', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '1 hours post-dose: C1 D15', 'categories': [{'measurements': [{'value': '2150', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '2 hours post-dose: C1 D15', 'categories': [{'measurements': [{'value': '2910', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose: C1 D15', 'categories': [{'measurements': [{'value': '2880', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '6 hours post-dose: C1 D15', 'categories': [{'measurements': [{'value': '2510', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': '8 hours post-dose: C1 D15', 'categories': [{'measurements': [{'value': '2320', 'spread': 'NA', 'comment': 'SD cannot be calculated for a single participant.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8 post-dose C1D1 and C1D15; pre-dose C1D8', 'description': 'Plasma samples were collected at specified timepoints for evaluation of adagrasib PK concentrations. It was calculated using NCA method.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of participants who had at least 1 measurable adagrasib concentration after the first dose.'}, {'type': 'SECONDARY', 'title': 'Part 3A: Percentage of Participants With Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3A- SAR442720 100mg BIW + Adagrasib', 'description': "Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '95.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessments performed till end of treatment, approximately 3 weeks', 'description': 'ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP.'}, {'type': 'SECONDARY', 'title': 'Part 3A: Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3A- SAR442720 100mg BIW + Adagrasib', 'description': "Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'timeFrame': 'Tumor assessments performed till end of treatment, approximately 3 weeks', 'description': 'DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any IMP and with BOR at least PR. Only responders with BOR with at least a PR were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Part 4: Time to Reach Maximum Plasma Concentration (Tmax) for SAR442720 Tablets and Capsules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4- SAR442720 200mg + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'classes': [{'title': 'C1D1 (Tablet/Fed)', 'categories': [{'measurements': [{'value': '3.75', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '24'}]}]}, {'title': 'C1D15 (Tablet/Fasted)', 'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '7.58'}]}]}, {'title': 'C2D1 (Capsules/Fasted)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1', 'description': 'Plasma samples were collected at specified timepoints to determine tmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population consisted of participants who completed all of C1 and C2D1 with meal information, full PK, and no dose reduction/missed doses on C1D1, C1D15 and C2D1.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1- SAR442720 140 mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 140 milligram (mg) orally twice a week (BIW) on Days 1 and 4 along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day cycles until disease progression, unacceptable adverse events (AEs), or the participant's or investigator's decision to stop the treatment."}, {'id': 'FG001', 'title': 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'FG002', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS)\\>=50% non-small cell lung cancer (NSCLC) were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg once in every 6 weeks (Q6W) (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'FG003', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'FG004', 'title': 'Part 3A- SAR442720 100mg BIW + Adagrasib', 'description': "Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg orally twice daily (BID) in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'FG005', 'title': 'Part 4- SAR442720 200mg + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'comment': 'Here reasons for not completed indicates reasons for treatment discontinuation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 20 centers in 7 countries. A total of 95 participants were screened (Part 1: 24; Part 2: 47; Part 3A: 1; Part 4: 23) between 09 June 2020 and 22 December 2022, of which 30 were screen failures.', 'preAssignmentDetails': 'The study was conducted in 4 parts (Part 1, 2, 3 and 4), Part 3 was divided into Part 3A and 3B, of which Part 3B was not initiated and no participants were enrolled. The study was terminated due to strategic reasons not related to safety.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '65', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1- SAR442720 140mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'BG001', 'title': 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment."}, {'id': 'BG002', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with PD-L1 TPS\\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'BG003', 'title': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'BG004', 'title': 'Part 3A- SAR442720 100mg BIW + Adagrasib', 'description': "Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'BG005', 'title': 'Part 4- SAR442720 200mg + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment."}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'From 18 to 64 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}]}, {'title': 'From 65 to 74 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}, {'title': '75 years and over', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '39', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population consisted of participants who took at least 1 dose of any investigational medicinal product (IMP).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-26', 'size': 1713921, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-01T04:44', 'hasProtocol': True}, {'date': '2022-07-14', 'size': 523308, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-01T04:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'whyStopped': "Sponsor's decision not related to any safety concern", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2020-05-29', 'resultsFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2020-06-02', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-01', 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From first dose of IMP up to 30 days after the last dose; approximately 27 weeks', 'description': 'AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.'}, {'measure': 'Parts 1 and 3A: Number of Participants With Treatment Related Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Cycle 1 (21 days)', 'description': "Potential DLTs were defined as the AEs that occurred during the first cycle (C) of treatment, considered by the investigator to be related to IMP, unless due to disease progression or to a cause obviously unrelated to IMP: Grade(G)\\>= 4 AEs, G3 neutropenia lasting \\>7 days or febrile neutropenia; G3 thrombocytopenia with clinically significant bleeding; any G\\>=3 immune-related AEs; G3 nonhematologic AEs; G3 aspartate transaminase, alanine transaminase, and/or total bilirubin elevations that persist \\>5 days; possible Hy's law case; G3 QT interval corrected using Fridericia's formula prolongation; retinal vein occlusion any grade; toxicity related to IMP leading to 50% or less dose intensity of SAR442720 and/or delay in initiation of C2 dosing of pembrolizumab by \\>15 days, in the absence of recovery to baseline or G \\<=1 AE. Potential DLT were reviewed by Sponsor and investigators to confirm them as DLTs."}, {'measure': 'Part 2: Percentage of Participants With Objective Response Rate (ORR)', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) determined by investigator per response evaluation criteria in solid tumors (RECIST) version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 millimeter (mm) OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The confidence interval (CI) was estimated using Clopper-Pearson method.'}, {'measure': 'Part 3A: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events', 'timeFrame': 'From first dose of IMP up to 30 days after the last dose; approximately 7 weeks', 'description': 'AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.'}, {'measure': 'Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on C1 D1, C1 D15, C2 D1; Pre-dose on C1 D8 and C6 D1; end of treatment (Week 45)', 'description': 'Plasma samples were collected at specified timepoints for pharmacokinetic (PK) analysis.'}, {'measure': 'Part 4: Area Under Curve From Zero to Last Concentration Timepoint (AUClast) for SAR442720 Tablets and Capsules', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2D1', 'description': 'Plasma samples were collected at specified timepoints to determine AUClast for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using non-compartmental analysis (NCA) method.'}, {'measure': 'Part 4: Maximum Observed Plasma Concentration (Cmax) for SAR442720 Tablets and Capsules', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1', 'description': 'Plasma samples were collected at specified timepoints to determine Cmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.'}, {'measure': 'Part 4: Time to Reach Maximum Plasma Concentration (Tmax) for SAR442720 Tablets and Capsules', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1', 'description': 'Plasma samples were collected at specified timepoints to determine tmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Plasma Concentration of SAR442720', 'timeFrame': 'Pre-dose, 2, 8, hours post-dose on C1 D1 and C2D1; pre-dose C1D8, C1D15, and C6D1; 2 hours C2D2; and end of treatment (Week 22)', 'description': 'Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.'}, {'measure': 'Part 2: Plasma Concentration of SAR442720', 'timeFrame': 'Pre-dose and 2 hours post-dose C1D1 and C2D1; pre-dose on C1D8, C1D15, C6D1; and end of treatment (Week 104)', 'description': 'Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.'}, {'measure': 'Parts 1 and 2: Serum Concentration of Pembrolizumab', 'timeFrame': 'Pre-dose and post-dose C1D1; pre-dose on C2D1 and C6D1', 'description': 'Serum samples were collected at specified timepoints for evaluation of pembrolizumab PK concentrations.'}, {'measure': 'Parts 1 and 4: Percentage of Participants With Objective Response Rate', 'timeFrame': 'Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks (Part 1), 46 weeks (Part 4)', 'description': 'ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.'}, {'measure': 'Part 1: Duration of Response (DoR)', 'timeFrame': 'Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks', 'description': 'DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive disease progression(PD) or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.'}, {'measure': 'Part 2: Duration of Response', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5mm. DoR was estimated using Kaplan-Meier method.'}, {'measure': 'Part 2: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events', 'timeFrame': 'From first dose of IMP up to 30 days after the last dose; approximately 111 weeks', 'description': 'AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.'}, {'measure': 'Part 4: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events', 'timeFrame': 'From first dose of IMP up to 30 days after the last dose; approximately 50 weeks', 'description': 'AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.'}, {'measure': 'Part 2: Time to Response (TTR)', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'TTR was defined as the time interval from the administration of first IMP dose to the first documented evidence of PR or CR determined by the Investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. TTR was estimated using Kaplan-Meier method.'}, {'measure': 'Part 2: Percentage of Participants With Clinical Benefit Rate', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'Clinical benefit rate was defined as the percentage of participants with confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The CI was estimated using Clopper-Pearson method.'}, {'measure': 'Part 2: Percentage of Participants With Disease Control Rate', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'Disease control rate was defined percentage of participants with confirmed CR or PR or SD as determined by the investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The CI was estimated using Clopper-Pearson method.'}, {'measure': 'Part 2: Progression Free Survival (PFS)', 'timeFrame': 'Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks', 'description': 'PFS was defined as the time from the date of first IMP administration to the date of the first documented PD determined by the investigator per RECIST version 1.1 or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. PFS was estimated using Kaplan-Meier method.'}, {'measure': 'Part 3A: Plasma Concentration of SAR442720', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post-dose C1D1; pre-dose C1D8; pre-dose, 0.5, 1, 2, 4, 6 post-dose C1D15, and end of treatment (Week 3)', 'description': 'Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations. It was calculated using NCA method.'}, {'measure': 'Part 3A: Plasma Concentration of Adagrasib', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8 post-dose C1D1 and C1D15; pre-dose C1D8', 'description': 'Plasma samples were collected at specified timepoints for evaluation of adagrasib PK concentrations. It was calculated using NCA method.'}, {'measure': 'Part 3A: Percentage of Participants With Objective Response Rate', 'timeFrame': 'Tumor assessments performed till end of treatment, approximately 3 weeks', 'description': 'ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.'}, {'measure': 'Part 3A: Duration of Response', 'timeFrame': 'Tumor assessments performed till end of treatment, approximately 3 weeks', 'description': 'DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://sanofi.trialsummaries.com/Study/StudyDetails?id=25347&tenant=MT_SNY_9011', 'label': 'TCD16210 Plain language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\n* Part 1\n* To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors.\n* To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors.\n* Part 2\n* To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab.\n* Part 3A\n* To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC\n* To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC\n* Part 3B\n* To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC\n* Part 4\n* To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab.\n* To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab.\n\nSecondary Objectives:\n\n* Part 1\n* To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720.\n* To estimate the anti-tumor effects of SAR442720 with pembrolizumab.\n* Part 2\n* To assess the safety profile of SAR442720 combined with pembrolizumab.\n* To assess other indicators of anti-tumor activity.\n* To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720.\n* Part 3A\n* To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720.\n* To estimate the anti-tumor effects of SAR442720 with adagrasib\n* Part 3B\n* To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC.\n* To assess other indicators of anti-tumor activity.\n* To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720.\n* Part 4\n* To assess the safety and tolerability of SAR442720 formulations with pembrolizumab\n* To estimate the anti-tumor effects of SAR442720 with pembrolizumab.', 'detailedDescription': 'This open label Phase 1 multicenter study was designed to evaluate the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SAR442720 in combination with pembrolizumab in participants with solid tumors in Part 1.\n\nIn Part 2, in the expansion cohort (Cohort A) we assessed the antitumor activity and safety of SAR442720 combined with pembrolizumab in participants with metastatic 1L lung cancer.\n\nIn Part 3, we evaluated the safety, MTD, RP2D and antitumor activity of SAR442720 in combination with adagrasib in participants with lung cancer and KRAS G12C mutation.\n\nIn Part 4, we evaluated the impact of the formulations (formulation 1 and formulation 2) and of the food on the PK of SAR442720 when dosed in combination with pembrolizumab. The expected duration of study intervention for participants may vary, based on progression date; median expected duration of study per participant was estimated to be about 10 months in Part 1, Part 3 and Part 4 (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up) and in Part 2 16 months (up to 1 month for screening, a median of 12 months for treatment and a median of 3 months for long term follow up.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must be ≥ 18 years of age.\n* Histologically proven diagnosis of advanced solid tumors.\n* Participants must have one or more of the following molecular aberrations (Part 1): KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations.\n* Participants must have following molecular aberration (Part 3A and 3B): - KRAS G12C mutation.\n* At least 1 measurable disease per RECIST 1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Woman of childbearing potential must agree to follow contraceptive guidance.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Predicted life expectancy \\<3 months.\n* Primary central nervous system (CNS) tumors.\n* Symptomatic or impending cord compression. Stable CNS disease was allowed.\n* History of cerebrovascular stroke or transient ischemic attack within previous 6 months.\n* Prior solid organ or hematologic transplant.\n* History or current retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vascular occlusion (RVO), neovascular macular degeneration.\n* Any clinically significant cardiac disease.\n* Active, known or suspected autoimmune disease.\n* History of or current interstitial lung disease or pneumonitis.\n* Receipt of a live-virus vaccination within 28 days, viral vaccine that do not contain live virus within 7 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.\n* Known infection with human immunodeficiency virus (HIV), known uncontrolled hepatitis B infection, active tuberculosis, or severe infection requiring parenteral antibiotic treatment.\n* Inadequate hematologic, hepatic and renal function.\n* Known second malignancy.\n* Impairment of gastrointestinal function.\n* Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol.\n* History of severe allergic reaction to any of the study intervention components.\n\nThe above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT04418661', 'briefTitle': 'Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of SAR442720 in Combination With Other Agents in Participants With Advanced Malignancies', 'orgStudyIdInfo': {'id': 'TCD16210'}, 'secondaryIdInfos': [{'id': 'U1111-1244-2555', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': 'TCD16210', 'type': 'OTHER', 'domain': 'Sanofi Identifier'}, {'id': '2020-000436-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1- SAR442720 140 mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 140 milligram (mg) orally twice a week (BIW) on Days 1 and 4 along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day cycles until disease progression, unacceptable adverse events (AEs), or the participant's or investigator's decision to stop the treatment.", 'interventionNames': ['Drug: Vociprotafib', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.", 'interventionNames': ['Drug: Vociprotafib', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'description': "Participants with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS)\\>=50% non-small cell lung cancer (NSCLC) were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg once in every 6 weeks (Q6W) (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.", 'interventionNames': ['Drug: Vociprotafib', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'description': "Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.", 'interventionNames': ['Drug: Vociprotafib', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3A- SAR442720 100mg BIW + Adagrasib', 'description': "Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg orally twice daily (BID) in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.", 'interventionNames': ['Drug: Vociprotafib', 'Drug: Adagrasib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4- SAR442720 200mg + Pembrolizumab', 'description': "Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.", 'interventionNames': ['Drug: Vociprotafib', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'Vociprotafib', 'type': 'DRUG', 'otherNames': ['SAR442720, RMC-4630'], 'description': 'Pharmaceutical form: Varies Route of administration: Varies', 'armGroupLabels': ['Part 1- SAR442720 140 mg BIW + Pembrolizumab', 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'Part 3A- SAR442720 100mg BIW + Adagrasib', 'Part 4- SAR442720 200mg + Pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Pharmaceutical form:Sterile Lyophilized powder for reconstitution Route of administration: Infusion', 'armGroupLabels': ['Part 1- SAR442720 140 mg BIW + Pembrolizumab', 'Part 1- SAR442720 200mg BIW + Pembrolizumab', 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)', 'Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)', 'Part 4- SAR442720 200mg + Pembrolizumab']}, {'name': 'Adagrasib', 'type': 'DRUG', 'description': 'Pharmaceutical form:Sterile Tablet Route of administration: Oral', 'armGroupLabels': ['Part 3A- SAR442720 100mg BIW + Adagrasib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine Medical Center- Site Number : 8400002', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center- Site Number : 8400001', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320003', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '1019', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320001', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1093', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320004', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1125', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320002', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '2031', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360002', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360001', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3084', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360003', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '4780000', 'city': 'Temuco', 'state': 'La Araucanía', 'country': 'Chile', 'facility': 'Investigational Site Number : 1520002', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'zip': '8420383', 'city': 'Santiago', 'state': 'Reg Metropolitana de Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number : 1520001', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '2520598', 'city': 'Viña del Mar', 'state': 'Región de Valparaíso', 'country': 'Chile', 'facility': 'Investigational Site Number : 1520003', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'zip': '13496', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Investigational Site Number : 4100002', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '28644', 'city': 'Cheongju-si', 'state': 'North Chungcheong', 'country': 'South Korea', 'facility': 'Investigational Site Number : 4100003', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'zip': '03722', 'city': 'Seoul', 'state': 'Seoul-teukbyeolsi', 'country': 'South Korea', 'facility': 'Investigational Site Number : 4100001', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240001', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240002', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240003', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Investigational Site Number : 1580002', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Investigational Site Number : 1580001', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Revolution Medicines, Inc.', 'class': 'INDUSTRY'}, {'name': 'Mirati Therapeutics Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}