Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT02864251
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for all-cause mortality from their randomization to study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 11 months and a maximum of 51 months).', 'description': 'The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study therapy or similar.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Nivolumab Plus Platinum-doublet Chemotherapy', 'description': "Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.\n\nTreatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nFollowing completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.", 'otherNumAtRisk': 141, 'deathsNumAtRisk': 144, 'otherNumAffected': 136, 'seriousNumAtRisk': 141, 'deathsNumAffected': 92, 'seriousNumAffected': 77}, {'id': 'EG001', 'title': 'Arm B: Nivolumab Plus Ipilimumab', 'description': 'Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 73, 'otherNumAffected': 62, 'seriousNumAtRisk': 71, 'deathsNumAffected': 55, 'seriousNumAffected': 46}, {'id': 'EG002', 'title': 'Arm C: Platinum Doublet Chemotherapy', 'description': "Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.\n\nParticipants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nPlatinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.\n\nParticipants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.", 'otherNumAtRisk': 143, 'deathsNumAtRisk': 150, 'otherNumAffected': 140, 'seriousNumAtRisk': 143, 'deathsNumAffected': 105, 'seriousNumAffected': 55}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 58}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 45}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 35}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 52}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 22}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Infections and 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'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pyelocaliectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Urticarial vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab Plus Platinum-doublet Chemotherapy', 'description': "Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.\n\nTreatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nFollowing completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment."}, {'id': 'OG001', 'title': 'Arm B: Nivolumab Plus Ipilimumab', 'description': 'Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.'}, {'id': 'OG002', 'title': 'Arm C: Platinum Doublet Chemotherapy', 'description': "Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.\n\nParticipants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nPlatinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.\n\nParticipants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity."}], 'classes': [{'categories': [{'measurements': [{'value': '5.59', 'groupId': 'OG000', 'lowerLimit': '4.47', 'upperLimit': '6.80'}, {'value': '1.54', 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': '2.63'}, {'value': '5.45', 'groupId': 'OG002', 'lowerLimit': '4.40', 'upperLimit': '5.65'}]}]}], 'analyses': [{'pValue': '0.0528', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.00', 'pValueComment': 'Log-rank test stratified by PD-L1 expression (\\>= 1% vs \\<1%/indeterminate/not evaluable), brain metastases (presence vs absence), smoking history (current/former vs never smoker), and prior osimertinib use (yes vs no) from IRT.', 'estimateComment': 'Arm A over Arm C Stratified Cox proportional hazard model.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.07', 'ciLowerLimit': '1.43', 'ciUpperLimit': '2.99', 'estimateComment': 'Arm B over Arm C Stratified Cox proportional hazard model.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of first documented tumor progression or death (approximately 58 months)', 'description': 'PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.\n\nParticipants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy.\n\nProgression is the appearance of one or more new lesions. RECIST - "response evaluation criteria in solid tumors" is a standard system to measure tumor response to treatment.\n\nBased on Kaplan-Meier estimates', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab Plus Platinum-doublet Chemotherapy', 'description': "Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.\n\nTreatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nFollowing completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment."}, {'id': 'OG001', 'title': 'Arm B: Nivolumab Plus Ipilimumab', 'description': 'Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.'}, {'id': 'OG002', 'title': 'Arm C: Platinum Doublet Chemotherapy', 'description': "Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.\n\nParticipants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nPlatinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.\n\nParticipants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity."}], 'classes': [{'categories': [{'measurements': [{'value': '19.35', 'groupId': 'OG000', 'lowerLimit': '16.13', 'upperLimit': '20.99'}, {'value': '17.12', 'groupId': 'OG001', 'lowerLimit': '13.67', 'upperLimit': '23.59'}, {'value': '15.90', 'groupId': 'OG002', 'lowerLimit': '14.00', 'upperLimit': '18.79'}]}]}], 'analyses': [{'pValue': '0.2180', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.12', 'estimateComment': 'Hazard Ratio (Arm A over Arm C) is based on a stratified Cox proportional hazard model', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.52', 'estimateComment': 'Hazard Ratio (Arm B over Arm C) is based on a stratified Cox proportional hazard model.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of death due to any cause (up to approximately 67 months)', 'description': 'Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.\n\nMedian based on Kaplan-Meier Estimates', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) by Blinded Independent Centralized Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab Plus Platinum-doublet Chemotherapy', 'description': "Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.\n\nTreatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nFollowing completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment."}, {'id': 'OG001', 'title': 'Arm B: Nivolumab Plus Ipilimumab', 'description': 'Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.'}, {'id': 'OG002', 'title': 'Arm C: Platinum Doublet Chemotherapy', 'description': "Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.\n\nParticipants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nPlatinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.\n\nParticipants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity."}], 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '23.2', 'upperLimit': '38.8'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '23.8'}, {'value': '26.7', 'groupId': 'OG002', 'lowerLimit': '19.8', 'upperLimit': '34.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.75', 'ciUpperLimit': '2.16', 'estimateComment': 'Strata adjusted odds ratio (Arm A over Arm C) using Mantel-Haenszel method.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (up to approximately 67 months)', 'description': 'ORR is number of randomized participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST v1.1 criteria by BICR assessment.\n\nBOR is the best response designation, between randomization and objectively documented progression per RECIST v1.1 criteria by BICR or the date of subsequent anti-cancer therapy, whichever occurs first.\n\nPR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \\<10 mm (whether target or non-target).\n\nRadiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy.\n\nCR+PR, confidence interval based on the Clopper and Pearson method.', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab Plus Platinum-doublet Chemotherapy', 'description': "Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.\n\nTreatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nFollowing completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment."}, {'id': 'OG001', 'title': 'Arm B: Nivolumab Plus Ipilimumab', 'description': 'Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.'}, {'id': 'OG002', 'title': 'Arm C: Platinum Doublet Chemotherapy', 'description': "Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.\n\nParticipants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nPlatinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.\n\nParticipants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity."}], 'classes': [{'categories': [{'measurements': [{'value': '6.67', 'groupId': 'OG000', 'lowerLimit': '4.17', 'upperLimit': '12.45'}, {'value': '50.04', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': 'NA'}, {'value': '5.55', 'groupId': 'OG002', 'lowerLimit': '4.07', 'upperLimit': '9.92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of first documented disease progression or death due to any cause (approximately 67 months)', 'description': 'DOR is the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not included), whichever occurred first.\n\nPR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \\<10 mm (whether target or non-target).\n\nRadiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy.\n\nParticipants who neither progress nor die were censored on the date of their last assessment.\n\nMedian computed using Kaplan-Meier method', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with CR or PR'}, {'type': 'SECONDARY', 'title': '9 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab Plus Platinum-doublet Chemotherapy', 'description': "Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.\n\nTreatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nFollowing completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment."}, {'id': 'OG001', 'title': 'Arm B: Nivolumab Plus Ipilimumab', 'description': 'Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.'}, {'id': 'OG002', 'title': 'Arm C: Platinum Doublet Chemotherapy', 'description': "Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.\n\nParticipants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nPlatinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.\n\nParticipants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity."}], 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '34.0'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '21.7'}, {'value': '19.8', 'groupId': 'OG002', 'lowerLimit': '12.6', 'upperLimit': '28.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months after first treatment dose', 'description': 'The PFSR at 9 months is defined as the percent of treated participants remaining progression free and surviving at 9 months since the first dosing date. Progression is the appearance of one or more new lesions.\n\nPoint estimates are derived from Kaplan-Meier analyses.', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': '12 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Nivolumab Plus Platinum-doublet Chemotherapy', 'description': "Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.\n\nTreatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nFollowing completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment."}, {'id': 'OG001', 'title': 'Arm B: Nivolumab Plus Ipilimumab', 'description': 'Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.'}, {'id': 'OG002', 'title': 'Arm C: Platinum Doublet Chemotherapy', 'description': "Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.\n\nParticipants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nPlatinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.\n\nParticipants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity."}], 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '29.1'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '21.7'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '9.3', 'upperLimit': '24.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months after first treatment dose', 'description': 'The PFSR at 12 months is defined as the percent of treated participants remaining progression free and surviving at 12 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Nivolumab Plus Platinum-doublet Chemotherapy', 'description': "Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.\n\nTreatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nFollowing completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment."}, {'id': 'FG001', 'title': 'Arm B: Nivolumab Plus Ipilimumab', 'description': 'Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.'}, {'id': 'FG002', 'title': 'Arm C: Platinum Doublet Chemotherapy', 'description': "Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.\n\nParticipants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nPlatinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.\n\nParticipants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity."}], 'periods': [{'title': 'Pre-Treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Started Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event Unrelated to Study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Participant no Longer Meets Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Started Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'comment': 'Completed Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '143'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '101'}]}, {'type': 'Study Drug Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event Unrelated to Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Participant Requested to Discontinue Study Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Maximum Clinical Benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Participant no Longer Meets Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Administrative Reason by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Arm B: Nivolumab plus Ipilimumab was exploratory and closed prior to primary completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '367', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Nivolumab Plus Platinum-doublet Chemotherapy', 'description': "Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles.\n\nTreatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nFollowing completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment."}, {'id': 'BG001', 'title': 'Arm B: Nivolumab Plus Ipilimumab', 'description': 'Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.'}, {'id': 'BG002', 'title': 'Arm C: Platinum Doublet Chemotherapy', 'description': "Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles.\n\nParticipants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle.\n\nPlatinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first.\n\nParticipants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '61.9', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '60.7', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '61.6', 'spread': '10.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '214', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '196', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '343', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-30', 'size': 6265801, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-10T14:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 367}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2016-08-09', 'resultsFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2016-08-09', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-10', 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)', 'timeFrame': 'From randomization to the date of first documented tumor progression or death (approximately 58 months)', 'description': 'PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.\n\nParticipants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy.\n\nProgression is the appearance of one or more new lesions. RECIST - "response evaluation criteria in solid tumors" is a standard system to measure tumor response to treatment.\n\nBased on Kaplan-Meier estimates'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization to the date of death due to any cause (up to approximately 67 months)', 'description': 'Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.\n\nMedian based on Kaplan-Meier Estimates'}, {'measure': 'Objective Response Rate (ORR) by Blinded Independent Centralized Review (BICR)', 'timeFrame': 'From randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (up to approximately 67 months)', 'description': 'ORR is number of randomized participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST v1.1 criteria by BICR assessment.\n\nBOR is the best response designation, between randomization and objectively documented progression per RECIST v1.1 criteria by BICR or the date of subsequent anti-cancer therapy, whichever occurs first.\n\nPR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \\<10 mm (whether target or non-target).\n\nRadiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy.\n\nCR+PR, confidence interval based on the Clopper and Pearson method.'}, {'measure': 'Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)', 'timeFrame': 'From randomization to the date of first documented disease progression or death due to any cause (approximately 67 months)', 'description': 'DOR is the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not included), whichever occurred first.\n\nPR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \\<10 mm (whether target or non-target).\n\nRadiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy.\n\nParticipants who neither progress nor die were censored on the date of their last assessment.\n\nMedian computed using Kaplan-Meier method'}, {'measure': '9 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)', 'timeFrame': '9 months after first treatment dose', 'description': 'The PFSR at 9 months is defined as the percent of treated participants remaining progression free and surviving at 9 months since the first dosing date. Progression is the appearance of one or more new lesions.\n\nPoint estimates are derived from Kaplan-Meier analyses.'}, {'measure': '12 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)', 'timeFrame': '12 Months after first treatment dose', 'description': 'The PFSR at 12 months is defined as the percent of treated participants remaining progression free and surviving at 12 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small-Cell Lung Carcinoma']}, 'referencesModule': {'references': [{'pmid': '38252907', 'type': 'DERIVED', 'citation': 'Mok T, Nakagawa K, Park K, Ohe Y, Girard N, Kim HR, Wu YL, Gainor J, Lee SH, Chiu CH, Kim SW, Yang CT, Wu CL, Wu L, Lin MC, Samol J, Ichikado K, Wang M, Zhang X, Sylvester J, Li S, Forslund A, Yang JC. Nivolumab Plus Chemotherapy in Epidermal Growth Factor Receptor-Mutated Metastatic Non-Small-Cell Lung Cancer After Disease Progression on Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: Final Results of CheckMate 722. J Clin Oncol. 2024 Apr 10;42(11):1252-1264. doi: 10.1200/JCO.23.01017. Epub 2024 Jan 22.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed stage IV or recurrent EGFR mutated NSCLC with disease progression on one or two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the local health authority, including but not limited to erlotinib, gefitinib, afatinib, dacomitinib and osimertinib). In osimertinib treated subjects, T790 testing is not required.\n* No evidence of exon 20 T790M mutation obtained at progression on prior first- or second-generation EGFR TKI therapy. For participants who were treated with osimertinib, T790M testing is not required.\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)\n* Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC).\n* Participants are eligible if central nervous system (CNS) metastases are considered to be adequately controlled/treated before or during the screening period and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization). Participants with asymptomatic CNS metastasis are eligible.\n* Eastern Cooperative Group (ECOG) Performance Status 0-1\n* Life expectancy is at least 3 months\n\nExclusion Criteria:\n\n* Known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI should receive osimertinib first as the standard of care (SOC). These participants are only eligible if they fail osimertinib as 2L.\n* who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.\n* Carcinomatous meningitis\n* Active, known or suspected autoimmune disease are excluded\n* ALK translocation\n* Known SCLC transformation\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n\nOther protocol defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT02864251', 'acronym': 'CheckMate722', 'briefTitle': 'A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy', 'orgStudyIdInfo': {'id': 'CA209-722'}, 'secondaryIdInfos': [{'id': '2017-002672-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nivolumab+Platinum doublet chemotherapy', 'interventionNames': ['Biological: Nivolumab', 'Drug: Pemetrexed', 'Drug: Cisplatin', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Nivolumab + Ipilimumab', 'description': 'Enrollment is closed for this arm', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Platinum doublet chemotherapy', 'interventionNames': ['Drug: Pemetrexed', 'Drug: Cisplatin', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['Opdivo', 'BMS-936558'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Nivolumab + Ipilimumab', 'Nivolumab+Platinum doublet chemotherapy']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Yervoy', 'BMS-734016'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Nivolumab + Ipilimumab']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Nivolumab+Platinum doublet chemotherapy', 'Platinum doublet chemotherapy']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Nivolumab+Platinum doublet chemotherapy', 'Platinum doublet chemotherapy']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Nivolumab+Platinum doublet chemotherapy', 'Platinum doublet chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90808', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Shores Medical Group', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 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