Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT04205812
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2019-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Mexico'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1-855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'otherDetails': 'Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to approximately 3.25 years', 'description': 'All-Cause Mortality was assessed for all randomized participants (Full Analysis Set). Adverse events were assessed for members of the Safety Population (participants who received at least 1 dose of study treatment) and the Monotherapy Analysis Set (participants who were randomized to the placebo group and received at least 1 dose of placebo, who then transitioned and received at least 1 dose of retifanlimab).', 'eventGroups': [{'id': 'EG000', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received retifanlimab 375 mg IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination.", 'otherNumAtRisk': 389, 'deathsNumAtRisk': 391, 'otherNumAffected': 350, 'seriousNumAtRisk': 389, 'deathsNumAffected': 234, 'seriousNumAffected': 158}, {'id': 'EG001', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo IV Q3W along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received placebo IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination.", 'otherNumAtRisk': 190, 'deathsNumAtRisk': 192, 'otherNumAffected': 177, 'seriousNumAtRisk': 190, 'deathsNumAffected': 140, 'seriousNumAffected': 57}, {'id': 'EG002', 'title': 'Randomized Treatment Period Total', 'description': 'Participants received retifanlimab 375 mg IV Q3W or matching placebo along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period.', 'otherNumAtRisk': 579, 'deathsNumAtRisk': 583, 'otherNumAffected': 527, 'seriousNumAtRisk': 579, 'deathsNumAffected': 374, 'seriousNumAffected': 215}, {'id': 'EG003', 'title': 'Retifanlimab Monotherapy', 'description': 'Participants randomized to placebo plus a platinum-based chemotherapy who experienced progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by blinded independent central review (BICR) had the opportunity to receive retifanlimab 375 mg IV Q3W for up to approximately 2 years (or up to 35 cycles \\[21-day cycles\\]) in the optional monotherapy treatment period.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 44, 'seriousNumAtRisk': 59, 'deathsNumAffected': 42, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 125, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 68, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 193, 'numAffected': 117}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 59, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 97, 'numAffected': 97}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 30, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 41, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 357, 'numAffected': 235}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 175, 'numAffected': 108}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 532, 'numAffected': 343}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 33, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 49, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 124, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 69, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 193, 'numAffected': 110}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 22, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 58, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 32, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 90, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 33, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 47, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 69, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 94, 'numAffected': 64}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 59, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 79, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 76, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 30, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 106, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 34, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 83, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 34, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 117, 'numAffected': 77}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 73, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 97, 'numAffected': 77}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 115, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 44, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 159, 'numAffected': 113}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 66, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 82, 'numAffected': 63}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 40, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 43, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 58, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 16, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 24, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 101, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 55, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 156, 'numAffected': 106}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 36, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 47, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 42, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 50, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 98, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 35, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 133, 'numAffected': 71}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 50, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 62, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 32, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 43, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 44, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 53, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 34, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Toxic epidermal necrolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vascular occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 579, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}, {'id': 'OG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '16.7'}, {'value': '18.1', 'groupId': 'OG001', 'lowerLimit': '16.2', 'upperLimit': '21.0'}]}]}], 'analyses': [{'pValue': '0.0042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.93', 'pValueComment': "The p-value was based on a stratified log-rank test at an overall 1-sided 2.5% level of significance, using O'Brien and Fleming boundary to adjust for alpha spending at interim analysis.", 'estimateComment': "A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 39.1 months', 'description': 'Overall survival was defined as the time between the date of randomization and the date of death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Median survival time in months was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. Full Analysis Set: all participants to whom study treatment had been assigned by randomization. Participants were analyzed according to the treatment and strata they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}, {'id': 'OG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '5.7'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '9.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.79', 'estimateComment': "A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value was based on the stratified log-rank test for PFS.'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 35.8 months', 'description': 'PFS was defined as the length of time from the date of randomization until the earliest date of disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by blinded independent central review (BICR), or death due to any cause, if occurring sooner than progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Median PFS time was estimated using the Kaplan-Meier method. The confidence interval for median PFS time was calculated using the method of Brookmeyer and Crowley.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}, {'id': 'OG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '45.8'}, {'value': '51.7', 'groupId': 'OG001', 'lowerLimit': '46.6', 'upperLimit': '56.7'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value was calculated at the 1-sided 2.5% level from stratified Cochran-Mantel-Haenszel test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 35.78 months', 'description': 'Objective response rate was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 based on BICR at any post-Baseline visit until the first progressive disease or new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}, {'id': 'OG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '8.3'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '15.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 34.3 months', 'description': 'Duration of response was defined as the time from the earliest date of documented response until the earliest date of disease progression or death from any cause, whichever comes first, per RECIST v1.1 based on BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set. Only those participants with a confirmed response were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}, {'id': 'OG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to approximately 39 months', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who received at least 1 dose of study treatment. Treatment groups for this population were determined by the actual treatment that the participant received regardless of treatment assignment at randomization.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}, {'id': 'OG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to approximately 39 months', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any TEAE in the Monotherapy Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retifanlimab Monotherapy', 'description': 'Participants randomized to placebo + platinum-based chemotherapy who experienced progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by blinded independent central review (BICR) had the opportunity to receive retifanlimab 375 mg IV Q3W for up to approximately 2 years (or up to 35 cycles \\[21-day cycles\\]) in the optional monotherapy treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to approximately 27 months', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Monotherapy Analysis Set: all participants who were randomized to the placebo group and received at least 1 dose of placebo, who then transitioned and received at least 1 dose of retifanlimab'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Drug Due to TEAEs in the Monotherapy Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retifanlimab Monotherapy', 'description': 'Participants randomized to placebo + platinum-based chemotherapy who experienced progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by blinded independent central review (BICR) had the opportunity to receive retifanlimab 375 mg IV Q3W for up to approximately 2 years (or up to 35 cycles \\[21-day cycles\\]) in the optional monotherapy treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to approximately 27 months', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Monotherapy Analysis Set'}, {'type': 'SECONDARY', 'title': 'Cmax1 of Retifanlimab When Administered With Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}, {'id': 'OG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'spread': '23.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1: pre-infusion and immediately after infusion', 'description': 'Cmax1 was defined as the first-dose maximum serum concentration of retifanlimab.', 'unitOfMeasure': 'milligrams per liter (mg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of retifanlimab and provided at least 1 PK post-dose sample'}, {'type': 'SECONDARY', 'title': 'AUC1 of Retifanlimab When Administered With Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}, {'id': 'OG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}], 'classes': [{'categories': [{'measurements': [{'value': '775', 'spread': '25.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1: pre-infusion and immediately after infusion', 'description': 'AUC1 was defined as the first-dose area under the serum concentration versus time curve.', 'unitOfMeasure': 'mg/L x day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Evaluable Population'}, {'type': 'SECONDARY', 'title': 'Cmaxss of Retifanlimab When Administered With Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}, {'id': 'OG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'spread': '23.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit.', 'description': 'Cmaxss was defined as the maximum serum concentration of retifanlimab at steady state.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Evaluable Population'}, {'type': 'SECONDARY', 'title': 'AUCss of Retifanlimab When Administered With Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}, {'id': 'OG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}], 'classes': [{'categories': [{'measurements': [{'value': '791', 'spread': '23.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit.', 'description': 'AUCss was defined as the area under the serum concentration versus time curve at steady state.', 'unitOfMeasure': 'mg/L x day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Evaluable Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. Participants who experienced progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by blinded independent central review (BICR) had the opportunity to receive retifanlimab 375 mg IV Q3W for up to approximately 2 years (or up to 35 cycles \\[21-day cycles\\]) in the optional monotherapy treatment period."}, {'id': 'FG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}], 'periods': [{'title': 'Randomized Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '391'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '391'}]}], 'dropWithdraws': [{'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '226'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Met Exclusion Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Monotherapy Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study was conducted in Bulgaria, Brazil, China, Czech Republic, Georgia, Malaysia, Philippines, Poland, Romania, Russia, Serbia, Turkey, Ukraine, United States, Vietnam, and South Africa. Data collected through 15 December 2023 have been included in this results summary.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'BG000'}, {'value': '391', 'groupId': 'BG001'}, {'value': '583', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + Chemotherapy', 'description': "Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 \\[D1\\]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m\\^2) + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. Participants who experienced progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by blinded independent central review (BICR) had the opportunity to receive retifanlimab 375 mg IV Q3W for up to approximately 2 years (or up to 35 cycles \\[21-day cycles\\]) in the optional monotherapy treatment period."}, {'id': 'BG001', 'title': 'Retifanlimab + Chemotherapy', 'description': "Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m\\^2 + either cisplatin 75 mg/m\\^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m\\^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m\\^2 (on D1) or nab-paclitaxel 100 mg/m\\^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '8.34', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '8.44', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '8.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '467', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '375', 'groupId': 'BG001'}, {'value': '559', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}]}, {'title': 'Black/African-American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Black/White biracial', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-18', 'size': 1362735, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-13T10:15', 'hasProtocol': True}, {'date': '2023-02-02', 'size': 668491, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-13T10:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 583}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT06910137', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2019-12-18', 'resultsFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-01-13', 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'up to 39.1 months', 'description': 'Overall survival was defined as the time between the date of randomization and the date of death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'up to 35.8 months', 'description': 'PFS was defined as the length of time from the date of randomization until the earliest date of disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by blinded independent central review (BICR), or death due to any cause, if occurring sooner than progression.'}, {'measure': 'Objective Response Rate', 'timeFrame': 'up to 35.78 months', 'description': 'Objective response rate was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 based on BICR at any post-Baseline visit until the first progressive disease or new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.'}, {'measure': 'Duration of Response', 'timeFrame': 'up to 34.3 months', 'description': 'Duration of response was defined as the time from the earliest date of documented response until the earliest date of disease progression or death from any cause, whichever comes first, per RECIST v1.1 based on BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.'}, {'measure': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period', 'timeFrame': 'up to approximately 39 months', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.'}, {'measure': 'Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period', 'timeFrame': 'up to approximately 39 months', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.'}, {'measure': 'Number of Participants With Any TEAE in the Monotherapy Treatment Period', 'timeFrame': 'up to approximately 27 months', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.'}, {'measure': 'Number of Participants Who Discontinued Study Drug Due to TEAEs in the Monotherapy Treatment Period', 'timeFrame': 'up to approximately 27 months', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.'}, {'measure': 'Cmax1 of Retifanlimab When Administered With Chemotherapy', 'timeFrame': 'Cycle 1 Day 1: pre-infusion and immediately after infusion', 'description': 'Cmax1 was defined as the first-dose maximum serum concentration of retifanlimab.'}, {'measure': 'AUC1 of Retifanlimab When Administered With Chemotherapy', 'timeFrame': 'Cycle 1 Day 1: pre-infusion and immediately after infusion', 'description': 'AUC1 was defined as the first-dose area under the serum concentration versus time curve.'}, {'measure': 'Cmaxss of Retifanlimab When Administered With Chemotherapy', 'timeFrame': 'Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit.', 'description': 'Cmaxss was defined as the maximum serum concentration of retifanlimab at steady state.'}, {'measure': 'AUCss of Retifanlimab When Administered With Chemotherapy', 'timeFrame': 'Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit.', 'description': 'AUCss was defined as the area under the serum concentration versus time curve at steady state.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic', 'non-small cell lung cancer', 'nonsquamous', 'squamous', 'PD-1', 'PD-L1'], 'conditions': ['Metastatic Squamous Non-Small Cell Lung Cancer', 'Metastatic Nonsquamous Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40983066', 'type': 'DERIVED', 'citation': 'Lu S, Vynnychenko O, Kulyaba Y, Kuchava V, Ibrahim A, Moiseenko F, Arslan C, Nguyen DT, Petrovic M, Cicin I, Bibichadze K, Cil T, Shi J, Olmez OF, Gogishvili M, Artac M, Nguyen HG, Cornfeld M, Tian C, Munteanu MC, Sette CVM, Bondarenko I; POD1UM-304 Study Team. Retifanlimab versus placebo in combination with platinum-based chemotherapy in patients with first-line non-squamous or squamous metastatic non-small-cell lung cancer (POD1UM-304): a phase 3, multiregional, placebo-controlled, double-blind, randomised study. Lancet Respir Med. 2025 Sep 19:S2213-2600(25)00209-7. doi: 10.1016/S2213-2600(25)00209-7. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8).\n* No prior systemic treatment for the advanced/metastatic NSCLC\n* Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy\n* Measurable disease per RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of at least 3 months.\n* Willingness to avoid pregnancy or fathering children.\n* Adequate organ function as indicated by protocol-specified laboratory values. - Has been fully vaccinated against SARS-CoV-2 or is willing and able to be fully vaccinated against SARS-CoV-2 during the study by starting the vaccination process during screening.\n\nExclusion Criteria:\n\n* Clinically significant cardiac disease within 6 months of start of study treatment.\n* Any major surgery within 3 weeks of the first dose of study treatment.\n* Thoracic radiation therapy of \\> 30 Gy within 6 months of the first dose of study treatment.\n* History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel.\n* Untreated central nervous system metastases and/or carcinomatous meningitis.\n* Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids.\n* Active infection requiring systemic therapy or active tuberculosis. Note: If required by country or local regulations to be tested for COVID-19 during screening, a participant should be excluded if they have a positive test result for SARS CoV-2 infection until both the retesting result is negative and clinical recovery is obtained.\n* Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.\n* Has contraindications to chemotherapy agents used in the study.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment.\n* Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug).\n\nNote: While based on approved SARS-CoV-2 vaccines available worldwide, many vaccines are not live (mRNA and adenovirus vaccines do not contain live virus), if a live vaccine against SARS-CoV-2 is the only available option, prior consultation with the medical monitor should be obtained.\n\n• Has known active HBV or HCV (testing must be performed to determine eligibility)'}, 'identificationModule': {'nctId': 'NCT04205812', 'acronym': 'POD1UM-304', 'briefTitle': 'Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)', 'orgStudyIdInfo': {'id': 'INCMGA 0012-304'}, 'secondaryIdInfos': [{'id': '2019-003372-39', 'type': 'EUDRACT_NUMBER'}, {'id': '2022-501987-16-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INCMGA00012 + chemotherapy (nonsquamous NSCLC)', 'description': 'INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.', 'interventionNames': ['Drug: Retifanlimab', 'Drug: Pemetrexed', 'Drug: Cisplatin', 'Drug: Carboplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + chemotherapy (nonsquamous NSCLC)', 'description': 'Placebo with pemetrexed + cisplatin OR carboplatin followed by placebo plus pemetrexed until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.', 'interventionNames': ['Drug: Placebo', 'Drug: Pemetrexed', 'Drug: Cisplatin', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'INCMGA00012 + chemotherapy (squamous NSCLC)', 'description': 'INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.', 'interventionNames': ['Drug: Retifanlimab', 'Drug: Carboplatin', 'Drug: Paclitaxel', 'Drug: nab-Paclitaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + chemotherapy (squamous NSCLC)', 'description': 'Placebo with carboplatin + paclitaxel OR nab-paclitaxel followed by placebo until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.', 'interventionNames': ['Drug: Placebo', 'Drug: Carboplatin', 'Drug: Paclitaxel', 'Drug: nab-Paclitaxel']}], 'interventions': [{'name': 'Retifanlimab', 'type': 'DRUG', 'otherNames': ['INCMGA00012'], 'description': 'INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.', 'armGroupLabels': ['INCMGA00012 + chemotherapy (nonsquamous NSCLC)', 'INCMGA00012 + chemotherapy (squamous NSCLC)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.', 'armGroupLabels': ['Placebo + chemotherapy (nonsquamous NSCLC)', 'Placebo + chemotherapy (squamous NSCLC)']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.', 'armGroupLabels': ['INCMGA00012 + chemotherapy (nonsquamous NSCLC)', 'Placebo + chemotherapy (nonsquamous NSCLC)']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.', 'armGroupLabels': ['INCMGA00012 + chemotherapy (nonsquamous NSCLC)', 'Placebo + chemotherapy (nonsquamous NSCLC)']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.', 'armGroupLabels': ['INCMGA00012 + chemotherapy (nonsquamous NSCLC)', 'INCMGA00012 + chemotherapy (squamous NSCLC)', 'Placebo + chemotherapy (nonsquamous NSCLC)', 'Placebo + chemotherapy (squamous NSCLC)']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.', 'armGroupLabels': ['INCMGA00012 + chemotherapy (squamous NSCLC)', 'Placebo + chemotherapy (squamous NSCLC)']}, {'name': 'nab-Paclitaxel', 'type': 'DRUG', 'description': 'nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.', 'armGroupLabels': ['INCMGA00012 + chemotherapy (squamous NSCLC)', 'Placebo + chemotherapy (squamous NSCLC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cancer Medical Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Innovative Clinical Research Institute', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '19612', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Reading Hospital and Medical Center', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}, {'zip': '14784-400', 'city': 'Barretos', 'country': 'Brazil', 'facility': 'Fundacao Pio Xii Hospital de Cancer de Barretos', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'zip': '95010-005', 'city': 'Caxias do Sul', 'country': 'Brazil', 'facility': 'Incan - 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