Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-02 @ 8:26 AM
Study NCT ID:
NCT04154956
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-05
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India', 'Lithuania', 'United Kingdom'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720449', 'term': 'tusamitamab ravtansine'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'TEAEs were collected from date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks. All-cause mortality data was collected from date of first study treatment administration (Day 1) until the primary analysis date of 22 September 2023 (up to 189 weeks).', 'description': 'Analysis was performed on safety population. All-cause mortality data was collected on randomized population.', 'eventGroups': [{'id': 'EG000', 'title': 'Tusamitamab Ravtansine', 'description': "Participants received tusamitamab ravtansine 100 mg/m\\^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks).", 'otherNumAtRisk': 194, 'deathsNumAtRisk': 194, 'otherNumAffected': 159, 'seriousNumAtRisk': 194, 'deathsNumAffected': 109, 'seriousNumAffected': 55}, {'id': 'EG001', 'title': 'Docetaxel', 'description': "Participants received docetaxel 75 mg/m\\^2 by IV infusion, once Q3W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks).", 'otherNumAtRisk': 177, 'deathsNumAtRisk': 195, 'otherNumAffected': 151, 'seriousNumAtRisk': 177, 'deathsNumAffected': 110, 'seriousNumAffected': 68}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 40, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 51, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Neuropathy Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Peripheral Sensory Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Keratopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 38, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 34, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 58, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 35, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 44, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 27, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 60, 'numAffected': 59}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 17, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 38, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 54, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 52, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 44, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 35, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Myelosuppression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Vertigo Positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Colitis Ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Colitis Ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Gastrointestinal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Mechanical Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Obstruction Gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Oesophageal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Interstitial Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Pneumothorax Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Productive Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Pulmonary Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}, {'term': 'Peripheral Artery Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tusamitamab Ravtansine', 'description': "Participants received tusamitamab ravtansine 100 mg/m\\^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks)."}, {'id': 'OG001', 'title': 'Docetaxel', 'description': "Participants received docetaxel 75 mg/m\\^2 by IV infusion, once Q3W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '5.39', 'groupId': 'OG000', 'lowerLimit': '3.713', 'upperLimit': '6.998'}, {'value': '5.85', 'groupId': 'OG001', 'lowerLimit': '5.520', 'upperLimit': '7.359'}]}]}], 'analyses': [{'pValue': '0.8204', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.143', 'ciLowerLimit': '0.864', 'ciUpperLimit': '1.512', 'pValueComment': 'One-sided significance level was 0.01', 'estimateComment': 'Hazard ratio and confidence intervals (CIs) were computed from a stratified Cox model according to stratification factors as per IRT.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documentation of objective PD as assessed by radiological review committee (IRC) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) definitions or death due to any cause before the study cut-off date, whichever occurred first. PD was defined as unequivocal progression of existing non-target lesions; appearance of 1 or more new lesions; at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tusamitamab Ravtansine', 'description': "Participants received tusamitamab ravtansine 100 mg/m\\^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks)."}, {'id': 'OG001', 'title': 'Docetaxel', 'description': "Participants received docetaxel 75 mg/m\\^2 by IV infusion, once Q3W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '12.81', 'groupId': 'OG000', 'lowerLimit': '11.795', 'upperLimit': '14.160'}, {'value': '11.53', 'groupId': 'OG001', 'lowerLimit': '8.936', 'upperLimit': '15.244'}]}]}], 'analyses': [{'pValue': '0.1120', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.846', 'ciLowerLimit': '0.644', 'ciUpperLimit': '1.109', 'pValueComment': 'One-sided significance level was 0.00174.', 'estimateComment': 'Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first study treatment administration (Day 1) until the date of death due to any cause, up to 189 weeks', 'description': 'Overall survival was defined as the time from date of randomization to date of death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tusamitamab Ravtansine', 'description': "Participants received tusamitamab ravtansine 100 mg/m\\^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks)."}, {'id': 'OG001', 'title': 'Docetaxel', 'description': "Participants received docetaxel 75 mg/m\\^2 by IV infusion, once Q3W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000', 'lowerLimit': '16.04', 'upperLimit': '28.26'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '18.13', 'upperLimit': '30.84'}]}]}], 'analyses': [{'pValue': '0.6972', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.42', 'pValueComment': 'P-value is provided for information only, there is no statistical inference based on this P-value.', 'estimateComment': 'Odds ratio and its 2-sided CI were provided from a Cochran-Mantel-Haenszel (CMH) test stratified according to the stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks', 'description': 'ORR was defined as the percentage of participants who had a complete response (CR) or partial response (PR), as best overall response derived from overall response (OR) determined by the IRC per RECIST 1.1. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. Only participants with randomization date ≥8 weeks prior to analysis cut-off date or with early PD prior to the cut-off date are reported.'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration (TTD) in Disease-related Symptoms as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer-specific Module With 13 Items (EORTC QLQ LC-13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tusamitamab Ravtansine', 'description': "Participants received tusamitamab ravtansine 100 mg/m\\^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks)."}, {'id': 'OG001', 'title': 'Docetaxel', 'description': "Participants received docetaxel 75 mg/m\\^2 by IV infusion, once Q3W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'groupId': 'OG000', 'lowerLimit': '2.103', 'upperLimit': '4.304'}, {'value': '1.87', 'groupId': 'OG001', 'lowerLimit': '1.544', 'upperLimit': '2.793'}]}]}], 'analyses': [{'pValue': '0.0157', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.729', 'ciLowerLimit': '0.546', 'ciUpperLimit': '0.972', 'pValueComment': 'P-value is provided for information only, there is no statistical inference based on this P-value.', 'estimateComment': 'Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks', 'description': 'The TTD was defined as the time from baseline (Cycle 1, Day 1) until the first ≥10-point change from baseline up to the end of treatment assessment before the initiation of further anticancer therapy and the analysis cut-off date. For the TTD in disease-related symptoms (cough, dyspnea, pain) from EORTC QLQ LC-13, a deterioration was defined as an increase from baseline score of at least 10 points in any 1 of these 3 symptoms. The EORTC QLQ-LC13 (LC13) is the lung cancer module of the EORTC QLQ-C30 that assesses lung-cancer-associated symptoms (cough, dyspnea, pain, hemoptysis) and side-effects from conventional chemotherapy and radiotherapy (sore mouth, hair loss, dysphagia and neuropathy). The EORTC QLQ-LC13 contains 13 items. Items on the LC13 were scored using the LC13 scoring algorithms which standardize the raw scores to a 0-100 range. Lower scores indicate lower symptomology/symptom burden (lower scores better).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database.'}, {'type': 'SECONDARY', 'title': 'TTD in Physical Function as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Cancer-specific Module With 30 Items (EORTC QLQ C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tusamitamab Ravtansine', 'description': "Participants received tusamitamab ravtansine 100 mg/m\\^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks)."}, {'id': 'OG001', 'title': 'Docetaxel', 'description': "Participants received docetaxel 75 mg/m\\^2 by IV infusion, once Q3W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '7.46', 'groupId': 'OG000', 'lowerLimit': '5.552', 'upperLimit': '15.211'}, {'value': '4.17', 'groupId': 'OG001', 'lowerLimit': '3.023', 'upperLimit': '4.567'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.544', 'ciLowerLimit': '0.388', 'ciUpperLimit': '0.763', 'pValueComment': 'P-value is provided for information only, there is no statistical inference based on this P-value.', 'estimateComment': 'Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks', 'description': 'TTD was defined as time from baseline(Cycle 1,Day 1) until first ≥10-point change from baseline up to end of treatment assessment before initiation of further anticancer therapy and analysis cut-off date.For TTD in physical function from EORTC QLQ-C30, deterioration=decrease of at least 10 points from baseline score.EORTC QLQ-C30(C30) is 30-item, cancer specific that includes global health status/health-related quality of life(GHS/QoL), functional scales(physical,role,emotional,cognitive,social), symptom scales(fatigue,nausea\\&vomiting,pain), 5 symptom items(dyspnea,insomnia,appetite loss,constipation,diarrhea,perceived financial difficulties). Most questions from QLQ-C30 were rated on 4-point scale(1/Not at All to 4/Very Much), except Items 29-30,which comprise GHS scale and were rated on 7-point scale(1/Very Poor to 7/Excellent). All scales were transformed from raw scores to linear scales ranging 0-100. High score represented favorable outcome with best quality of life.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database.'}, {'type': 'SECONDARY', 'title': 'TTD in Role Function Measured by EORTC QLQ C30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tusamitamab Ravtansine', 'description': "Participants received tusamitamab ravtansine 100 mg/m\\^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks)."}, {'id': 'OG001', 'title': 'Docetaxel', 'description': "Participants received docetaxel 75 mg/m\\^2 by IV infusion, once Q3W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '5.55', 'groupId': 'OG000', 'lowerLimit': '3.713', 'upperLimit': '6.308'}, {'value': '4.17', 'groupId': 'OG001', 'lowerLimit': '2.793', 'upperLimit': '4.370'}]}]}], 'analyses': [{'pValue': '0.0305', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.735', 'ciLowerLimit': '0.533', 'ciUpperLimit': '1.014', 'pValueComment': 'P-value is provided for information only, there is no statistical inference based on this P-value.', 'estimateComment': 'Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks', 'description': 'TTD was defined as time from baseline (Cycle 1, Day 1) until first ≥10-point change from baseline up to end of treatment assessment before initiation of further anticancer therapy and analysis cut-off date. For TTD in role function from EORTC QLQ-C30, deterioration = decrease of at least 10 points from baseline score. EORTC QLQ-C30 (C30) is a 30-item, cancer specific that includes GHS/QoL, functional scales (physical, role, emotional, cognitive, social), symptom scales (fatigue, nausea \\& vomiting, pain), 5 symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, perceived financial difficulties item). Most questions from QLQ-C30 were rated on a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were rated on a 7-point scale (1/Very Poor to 7/Excellent). All scales were transformed from raw scores to linear scales ranging 0 to 100. A high score represented a favorable outcome with a best quality of life for participant.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks', 'description': 'An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as 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 disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment period.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-08'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters', 'timeFrame': 'From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks', 'description': 'Blood samples were collected to determine the abnormalities in hematology parameters.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-08'}, {'type': 'SECONDARY', 'title': 'Number of Participants With PCSA in Clinical Chemistry', 'timeFrame': 'From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks', 'description': 'Blood samples were collected to determine the clinical chemistry laboratory abnormalities.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-08'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tusamitamab Ravtansine', 'description': "Participants received tusamitamab ravtansine 100 mg/m\\^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks)."}, {'id': 'OG001', 'title': 'Docetaxel', 'description': "Participants received docetaxel 75 mg/m\\^2 by IV infusion, once Q3W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '11.07', 'groupId': 'OG000', 'lowerLimit': '5.158', 'upperLimit': '19.844'}, {'value': '5.75', 'groupId': 'OG001', 'lowerLimit': '4.074', 'upperLimit': '7.326'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks', 'description': 'DOR was defined as the time from the date of first initial occurrence of a CR or PR to the date of first documentation of objective PD according to RECIST 1.1 before the initiation of any posttreatment anticancer therapy or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as unequivocal progression of existing non-target lesions; appearance of 1 or more new lesions; at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. Only participants with randomization date ≥8 weeks prior to analysis cut-off date or with early PD prior to the cut-off date are reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tusamitamab Ravtansine', 'description': "Participants received tusamitamab ravtansine 100 milligrams per square meter (mg/m\\^2) by intravenous (IV) infusion, once every 2 weeks (Q2W) until objective progressive disease (PD), unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks)."}, {'id': 'FG001', 'title': 'Docetaxel', 'description': "Participants received docetaxel 75 mg/m\\^2 by IV infusion, once every 3 weeks (Q3W) until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '195'}]}, {'type': 'Randomized and Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '143'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'Not related to Coronavirus disease 2019', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Ongoing study treatment at the time of primary analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}], 'recruitmentDetails': 'The study was conducted at 161 centers in 25 countries from 06 February 2020 to 22 September 2023 (primary completion date). Results are reported as per the primary completion date of 22 September 2023.', 'preAssignmentDetails': 'A total of 490 participants were screened, of which 389 participants were randomized in a ratio of 1:1 to either tusamitamab ravtansine or docetaxel arm. The randomization was stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1), previous immune checkpoint inhibitor treatment (sequential versus combination with chemotherapy) and geographical region (Asia versus Western Europe + Australia + North America versus Rest of the World \\[RoW\\]).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tusamitamab Ravtansine', 'description': "Participants received tusamitamab ravtansine 100 mg/m\\^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks)."}, {'id': 'BG001', 'title': 'Docetaxel', 'description': "Participants received docetaxel 75 mg/m\\^2 by IV infusion, once Q3W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks)."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Not reported', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized participants consisted of all participants with a signed main study informed consent form who had a treatment kit number allocated and recorded in the interactive response technology (IRT) database, regardless of whether the treatment kit was used or not.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-13', 'size': 1378919, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-12T09:22', 'hasProtocol': True}, {'date': '2023-07-28', 'size': 1358628, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-12T09:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 389}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2019-11-05', 'resultsFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-30', 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documentation of objective PD as assessed by radiological review committee (IRC) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) definitions or death due to any cause before the study cut-off date, whichever occurred first. PD was defined as unequivocal progression of existing non-target lesions; appearance of 1 or more new lesions; at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From date of first study treatment administration (Day 1) until the date of death due to any cause, up to 189 weeks', 'description': 'Overall survival was defined as the time from date of randomization to date of death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks', 'description': 'ORR was defined as the percentage of participants who had a complete response (CR) or partial response (PR), as best overall response derived from overall response (OR) determined by the IRC per RECIST 1.1. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Time to Deterioration (TTD) in Disease-related Symptoms as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer-specific Module With 13 Items (EORTC QLQ LC-13)', 'timeFrame': 'Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks', 'description': 'The TTD was defined as the time from baseline (Cycle 1, Day 1) until the first ≥10-point change from baseline up to the end of treatment assessment before the initiation of further anticancer therapy and the analysis cut-off date. For the TTD in disease-related symptoms (cough, dyspnea, pain) from EORTC QLQ LC-13, a deterioration was defined as an increase from baseline score of at least 10 points in any 1 of these 3 symptoms. The EORTC QLQ-LC13 (LC13) is the lung cancer module of the EORTC QLQ-C30 that assesses lung-cancer-associated symptoms (cough, dyspnea, pain, hemoptysis) and side-effects from conventional chemotherapy and radiotherapy (sore mouth, hair loss, dysphagia and neuropathy). The EORTC QLQ-LC13 contains 13 items. Items on the LC13 were scored using the LC13 scoring algorithms which standardize the raw scores to a 0-100 range. Lower scores indicate lower symptomology/symptom burden (lower scores better).'}, {'measure': 'TTD in Physical Function as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Cancer-specific Module With 30 Items (EORTC QLQ C30)', 'timeFrame': 'Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks', 'description': 'TTD was defined as time from baseline(Cycle 1,Day 1) until first ≥10-point change from baseline up to end of treatment assessment before initiation of further anticancer therapy and analysis cut-off date.For TTD in physical function from EORTC QLQ-C30, deterioration=decrease of at least 10 points from baseline score.EORTC QLQ-C30(C30) is 30-item, cancer specific that includes global health status/health-related quality of life(GHS/QoL), functional scales(physical,role,emotional,cognitive,social), symptom scales(fatigue,nausea\\&vomiting,pain), 5 symptom items(dyspnea,insomnia,appetite loss,constipation,diarrhea,perceived financial difficulties). Most questions from QLQ-C30 were rated on 4-point scale(1/Not at All to 4/Very Much), except Items 29-30,which comprise GHS scale and were rated on 7-point scale(1/Very Poor to 7/Excellent). All scales were transformed from raw scores to linear scales ranging 0-100. High score represented favorable outcome with best quality of life.'}, {'measure': 'TTD in Role Function Measured by EORTC QLQ C30', 'timeFrame': 'Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks', 'description': 'TTD was defined as time from baseline (Cycle 1, Day 1) until first ≥10-point change from baseline up to end of treatment assessment before initiation of further anticancer therapy and analysis cut-off date. For TTD in role function from EORTC QLQ-C30, deterioration = decrease of at least 10 points from baseline score. EORTC QLQ-C30 (C30) is a 30-item, cancer specific that includes GHS/QoL, functional scales (physical, role, emotional, cognitive, social), symptom scales (fatigue, nausea \\& vomiting, pain), 5 symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, perceived financial difficulties item). Most questions from QLQ-C30 were rated on a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were rated on a 7-point scale (1/Very Poor to 7/Excellent). All scales were transformed from raw scores to linear scales ranging 0 to 100. A high score represented a favorable outcome with a best quality of life for participant.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks', 'description': 'An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as 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 disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment period.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters', 'timeFrame': 'From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks', 'description': 'Blood samples were collected to determine the abnormalities in hematology parameters.'}, {'measure': 'Number of Participants With PCSA in Clinical Chemistry', 'timeFrame': 'From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks', 'description': 'Blood samples were collected to determine the clinical chemistry laboratory abnormalities.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks', 'description': 'DOR was defined as the time from the date of first initial occurrence of a CR or PR to the date of first documentation of objective PD according to RECIST 1.1 before the initiation of any posttreatment anticancer therapy or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as unequivocal progression of existing non-target lesions; appearance of 1 or more new lesions; at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\n* Study was designed with multiple primary endpoints analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival \\[PFS\\] and overall survival \\[OS\\])\n* Study success was defined either on PFS or OS\n* The primary objective was to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI)\n* The primary objective was to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor.\n\nSecondary Objectives:\n\n* Compared the objective response rate (ORR) of tusamitamab ravtansine with docetaxel\n* Compared the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel\n* Evaluated the safety of tusamitamab ravtansine compared to docetaxel\n* Assessed the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel', 'detailedDescription': 'The median expected duration of study per participant was estimated as median 9 months in docetaxel arm (1 month for screening, 4 months for treatment, and 4 months for the EOT and follow-up visits) and 12.5 months in SAR408701 arm (1 month for screening, 6.5 months for treatment, and 5 months for end of treatment follow-up).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 years of age or above (or country's legal age of maturity if above 18 years) and signed the informed consent.\n* Histologically or cytologically proven diagnosis of non-squamous NSCLC with metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.\n* Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of greater than or equal to 2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50% of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC).\n* At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiologist assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* A female participant who agreed to use highly effective contraceptive methods during and for at least 7 months after the last dose of study intervention.\n* A male participant who agreed to use highly effective contraception methods during and for at least 6 months after the last dose of study intervention.\n\nExclusion Criteria:\n\n* Participants with untreated brain metastases and history of leptomeningeal disease. if previously treated brain metastases no documentation of non-progressive disease in brain by imaging performed at least 4 weeks after CNS directed treatment and at least 2 weeks prior to the first dose of study intervention.\n* Significant concomitant illnesses, including all severe medical conditions that would impair the participation in the study or interpretation of the results.\n* History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.\n* Non-resolution of any prior treatment related toxicity to less than grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (V) 5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy\n* History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis\n* Previous history of and/or unresolved corneal disorders. The use of contact lenses was not permitted.\n* Concurrent treatment with any other anticancer therapy.\n* Prior treatment with docetaxel or maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.\n* Contraindicated the use of corticosteroid premedication.\n* Previous enrollment in this study and current participation in any other clinical study involving an investigational study treatment or any other type of medical research.\n* Poor bone marrow, liver or kidney functions\n* Hypersensitivity to any of the study interventions, or components thereof (EDTA), or drug (paclitaxel, polysorbate 80) or other allergy that, in the opinion of the Investigator, contraindicated participation in the study.\n\nThe above information was not intended to contain all considerations relevant to a potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT04154956', 'acronym': 'CARMEN-LC03', 'briefTitle': 'SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Randomized, Open-label, Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated, Metastatic Nonsquamous, Non-small-cell Lung Cancer Patients With CEACAM5-positive Tumors', 'orgStudyIdInfo': {'id': 'EFC15858'}, 'secondaryIdInfos': [{'id': 'U1111-1233-0781', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': '2024-515101-26-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': '2019-001273-81', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAR408701 (tusamitamab ravtansine)', 'description': "Participants received tusamitamab ravtansine 100 milligrams per square meter (mg/m\\^2) by intravenous (IV) infusion, once every 2 weeks (Q2W) until objective progressive disease (PD), unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks).", 'interventionNames': ['Drug: SAR408701']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Docetaxel', 'description': "Participants received docetaxel 75 mg/m\\^2 by IV infusion, once every 3 weeks (Q3W) until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks).", 'interventionNames': ['Drug: Docetaxel']}], 'interventions': [{'name': 'SAR408701', 'type': 'DRUG', 'description': 'Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: intravenous (IV) infusion', 'armGroupLabels': ['SAR408701 (tusamitamab ravtansine)']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['TAXOTERE'], 'description': 'Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: IV infusion', 'armGroupLabels': ['Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists South Division- Site Number : 8400020', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists North Division- Site Number : 8400019', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ca & Hem Center Of W Michigan- Site Number : 8400016', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute Site Number : 8400011', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '19096-3411', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lankenau Hospital Cancer Center- Site Number : 8400017', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '79915', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Renovatio Clinical- Site Number : 8400032', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Renovatio Clinical - Site Number : 8400013', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin- Site Number : 8400006', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'C1019ABS', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320009'}, {'zip': '1012', 'city': 'Capital Federal', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320012'}, {'zip': 'R8500ACE', 'city': 'Viedma', 'state': 'Río Negro Province', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320003', 'geoPoint': {'lat': -40.81519, 'lon': -63.0004}}, {'zip': '1426ANZ', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320001', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1125ABD', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320004', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'ZCX5000AAI', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320014', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '4400', 'city': 'Salta', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320002', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'zip': '2148', 'city': 'Blacktown', 'state': 'New South Wales', 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