Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT01673867
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2012-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Africa', 'Turkey (Türkiye)']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000077143', 'term': 'Docetaxel'}], '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': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '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 randomization until study completion (up to approximately 110 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 108 months).', 'description': 'All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants.\n\nARM 1: AEs that occurred on 3 mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3 mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab.', 'eventGroups': [{'id': 'EG000', 'title': 'Nivolumab 3 mg/kg', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.', 'otherNumAtRisk': 287, 'deathsNumAtRisk': 292, 'otherNumAffected': 267, 'seriousNumAtRisk': 287, 'deathsNumAffected': 258, 'seriousNumAffected': 172}, {'id': 'EG001', 'title': 'Nivolumab 480 mg', 'description': 'Nivolumab 480 mg solution administered intravenously every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 12, 'seriousNumAtRisk': 15, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.', 'otherNumAtRisk': 268, 'deathsNumAtRisk': 290, 'otherNumAffected': 258, 'seriousNumAtRisk': 268, 'deathsNumAffected': 266, 'seriousNumAffected': 161}, {'id': 'EG003', 'title': 'Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg', 'description': 'Eligible participants from the Docetaxel arm who transitioned to nivolumab 3 mg/kg every 2 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 12, 'seriousNumAtRisk': 17, 'deathsNumAffected': 14, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'Extension Phase of Docetaxel Arm: Nivolumab 480 mg', 'description': 'Eligible participants from the Docetaxel arm who transitioned to nivolumab 480 mg every 4 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 68}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 82}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 74}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 85}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 63}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 104}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 64}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 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thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.19', 'groupId': 'OG000', 'lowerLimit': '9.66', 'upperLimit': '14.98'}, {'value': '9.36', 'groupId': 'OG001', 'lowerLimit': '8.05', 'upperLimit': '10.68'}]}]}], 'analyses': [{'pValue': '0.0015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.92', 'paramValue': '0.73', 'ciLowerLimit': '0.59', 'ciUpperLimit': '0.89', 'estimateComment': 'HR = Nivolumab over docetaxel', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization until 413 deaths, up to March 2015 (approximately 29 months)', 'description': 'Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '24.5'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '17.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to date of objectively documented progression (up to approximately 110 months)', 'description': 'ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Time To Objective Response (TTOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.10', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '34.6'}, {'value': '2.73', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '31.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of first confirmed response (up to approximately 110 months)', 'description': 'Time to Objective Response for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who demonstrate partial response (PR) or complete response (CR)'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response (DOOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.15', 'groupId': 'OG000', 'lowerLimit': '10.78', 'upperLimit': '30.75'}, {'value': '5.55', 'groupId': 'OG001', 'lowerLimit': '4.40', 'upperLimit': '7.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)', 'description': 'DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment. Median computed using Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who demonstrate partial response (PR) or complete response (CR)'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'groupId': 'OG000', 'lowerLimit': '2.17', 'upperLimit': '3.32'}, {'value': '4.44', 'groupId': 'OG001', 'lowerLimit': '3.45', 'upperLimit': '4.86'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)', 'description': 'PFS was defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '22.7'}, {'value': '19.7', 'groupId': 'OG001', 'lowerLimit': '15.2', 'upperLimit': '24.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Week 12', 'description': 'Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) by PD-L1 Expression at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}], 'classes': [{'title': 'Participants with baseline PD-L1 expression ≥ 5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.91', 'groupId': 'OG000', 'lowerLimit': '15.08', 'upperLimit': '26.12'}, {'value': '8.11', 'groupId': 'OG001', 'lowerLimit': '6.47', 'upperLimit': '10.05'}]}]}, {'title': 'Participants with baseline PD-L1 expression < 5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.86', 'groupId': 'OG000', 'lowerLimit': '6.93', 'upperLimit': '12.81'}, {'value': '10.28', 'groupId': 'OG001', 'lowerLimit': '8.54', 'upperLimit': '11.96'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of death or last known date alive (up to approximately 110 months)', 'description': 'Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Median computed using the Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a tumor biopsy assessed for PD-L1 expression'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) by PD-L1 Expression at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}], 'classes': [{'title': 'Participants with baseline PD-L1 expression ≥ 5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '46.7'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '21.7'}]}]}, {'title': 'Participants with baseline PD-L1 expression < 5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '17.4'}, {'value': '14.5', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '21.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to date of objectively documented progression (up to approximately 110 months)', 'description': 'ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a tumor biopsy assessed for PD-L1 expression'}, {'type': 'POST_HOC', 'title': 'Overall Survival (OS) - Extended Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.21', 'groupId': 'OG000', 'lowerLimit': '9.66', 'upperLimit': '15.08'}, {'value': '9.49', 'groupId': 'OG001', 'lowerLimit': '8.11', 'upperLimit': '10.74'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of death or last known date alive (up to approximately 110 months)', 'description': 'Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median computed using Kaplan-Meier method. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until December 17, 2021).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'FG001', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}], 'periods': [{'title': 'Randomization', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}, {'groupId': 'FG001', 'numSubjects': '290'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Received treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}, {'groupId': 'FG001', 'numSubjects': '268'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant request to discontinue study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Received treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}, {'groupId': 'FG001', 'numSubjects': '268'}]}, {'type': 'Participants Who Transitioned to Nivolumab 3 mg/kg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Participants Who Transitioned to Nivolumab 480 mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Completed treatment period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '285'}, {'groupId': 'FG001', 'numSubjects': '268'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'Study Drug Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Participant request to discontinue study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Withdrawal by participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Maximum clinical benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Participant no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative reason by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '582', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nivolumab', 'description': 'Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'BG001', 'title': 'Docetaxel', 'description': 'Docetaxel 75mg/m\\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'spread': '9.27', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '9.75', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '9.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 582}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03126643', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-13', 'studyFirstSubmitDate': '2012-08-24', 'resultsFirstSubmitDate': '2016-01-29', 'studyFirstSubmitQcDate': '2012-08-24', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-29', 'studyFirstPostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint', 'timeFrame': 'Randomization until 413 deaths, up to March 2015 (approximately 29 months)', 'description': 'Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From randomization to date of objectively documented progression (up to approximately 110 months)', 'description': 'ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.'}, {'measure': 'Time To Objective Response (TTOR)', 'timeFrame': 'From randomization to the date of first confirmed response (up to approximately 110 months)', 'description': 'Time to Objective Response for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.'}, {'measure': 'Duration of Objective Response (DOOR)', 'timeFrame': 'From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)', 'description': 'DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment. Median computed using Kaplan-Meier method.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)', 'description': 'PFS was defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.'}, {'measure': 'Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12', 'timeFrame': 'Randomization to Week 12', 'description': 'Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.'}, {'measure': 'Overall Survival (OS) by PD-L1 Expression at Baseline', 'timeFrame': 'From randomization to the date of death or last known date alive (up to approximately 110 months)', 'description': 'Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Median computed using the Kaplan-Meier method.'}, {'measure': 'Objective Response Rate (ORR) by PD-L1 Expression at Baseline', 'timeFrame': 'From randomization to date of objectively documented progression (up to approximately 110 months)', 'description': 'ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Squamous Cell Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '37264091', 'type': 'DERIVED', 'citation': 'Barrera C, Corredor G, Viswanathan VS, Ding R, Toro P, Fu P, Buzzy C, Lu C, Velu P, Zens P, Berezowska S, Belete M, Balli D, Chang H, Baxi V, Syrigos K, Rimm DL, Velcheti V, Schalper K, Romero E, Madabhushi A. Deep computational image analysis of immune cell niches reveals treatment-specific outcome associations in lung cancer. NPJ Precis Oncol. 2023 Jun 1;7(1):52. doi: 10.1038/s41698-023-00403-x.'}, {'pmid': '36897427', 'type': 'DERIVED', 'citation': 'Hu S, Tang Z, Harrison JP, Hertel N, Penrod JR, May JR, Juarez-Garcia A, Holdgate O. Economic Evaluation of Nivolumab Versus Docetaxel for the Treatment of Advanced Squamous and Non-squamous Non-small Cell Lung Cancer After Prior Chemotherapy in China. Pharmacoecon Open. 2023 Mar;7(2):273-284. doi: 10.1007/s41669-022-00383-x. Epub 2023 Mar 10.'}, {'pmid': '33449799', 'type': 'DERIVED', 'citation': 'Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wojcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, Garcia MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. doi: 10.1200/JCO.20.01605. Epub 2021 Jan 15.'}, {'pmid': '30215677', 'type': 'DERIVED', 'citation': 'Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.'}, {'pmid': '30103096', 'type': 'DERIVED', 'citation': 'Reck M, Brahmer J, Bennett B, Taylor F, Penrod JR, DeRosa M, Dastani H, Spigel DR, Gralla RJ. Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. Eur J Cancer. 2018 Oct;102:23-30. doi: 10.1016/j.ejca.2018.05.005. Epub 2018 Aug 10.'}, {'pmid': '29408986', 'type': 'DERIVED', 'citation': 'Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Aren Frontera O, Gettinger S, Holgado E, Spigel D, Waterhouse D, Domine M, Garassino M, Chow LQM, Blumenschein G Jr, Barlesi F, Coudert B, Gainor J, Arrieta O, Brahmer J, Butts C, Steins M, Geese WJ, Li A, Healey D, Crino L. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018 Apr 1;29(4):959-965. doi: 10.1093/annonc/mdy041.'}, {'pmid': '29023213', 'type': 'DERIVED', 'citation': 'Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhaeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crino L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE. Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017 Dec 10;35(35):3924-3933. doi: 10.1200/JCO.2017.74.3062. Epub 2017 Oct 12.'}, {'pmid': '26412456', 'type': 'DERIVED', 'citation': 'Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.'}], '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 purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy', 'detailedDescription': 'CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men \\& women ≥18 years of age\n* Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for advanced disease\n* Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease\n* Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n* A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient\n\nExclusion Criteria:\n\n* Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are asymptomatic or treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10mg daily prednisone (or equivalent)\n* Subjects with carcinomatous meningitis\n* Subjects with active or recent history of known or suspected autoimmune disease. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll\n* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization\n* Prior therapy with anti-programmed death-1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), anti-programmed cell death ligand 2 (anti-PD-L2), anti-cluster of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)\n* Prior treatment with Docetaxel\n* Treatment with any investigational agent within 14 days of first administration of study treatment\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT01673867', 'acronym': 'CheckMate057', 'briefTitle': 'Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'CA209-057'}, 'secondaryIdInfos': [{'id': '2012-002472-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Nivolumab', 'description': 'Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.', 'interventionNames': ['Biological: Nivolumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: Docetaxel', 'description': 'Docetaxel 75 mg/m\\^2 concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. 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