Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-22 @ 9:27 AM
Study NCT ID:
NCT04026412
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2019-07-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}}}}, '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': 'C000613593', 'term': 'durvalumab'}], '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'}]}}, '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': 'All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).', 'description': 'All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.', 'otherNumAtRisk': 282, 'deathsNumAtRisk': 287, 'otherNumAffected': 273, 'seriousNumAtRisk': 282, 'deathsNumAffected': 132, 'seriousNumAffected': 180}, {'id': 'EG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.', 'otherNumAtRisk': 318, 'deathsNumAtRisk': 320, 'otherNumAffected': 310, 'seriousNumAtRisk': 318, 'deathsNumAffected': 132, 'seriousNumAffected': 181}, {'id': 'EG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.', 'otherNumAtRisk': 317, 'deathsNumAtRisk': 318, 'otherNumAffected': 307, 'seriousNumAtRisk': 317, 'deathsNumAffected': 132, 'seriousNumAffected': 145}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 132}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 134}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 44}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 29}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 16}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 32}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 89}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 104}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 108}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 69}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 77}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Radiation oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 56}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Radiation pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 48}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 32}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 43}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 37}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 57}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 48}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 63}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 77}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 51}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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{'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Respiratory tract haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Tracheal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Pemphigus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 317, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.69', 'groupId': 'OG000', 'lowerLimit': '12.58', 'upperLimit': '21.98'}, {'value': '15.64', 'groupId': 'OG001', 'lowerLimit': '13.67', 'upperLimit': '19.75'}]}]}], 'analyses': [{'pValue': '0.6460', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '96', 'paramValue': '0.95', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.19', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months)', 'description': 'Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participant in Arm A and C were only considered in the analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.60', 'comment': 'UL for 95% CI Not estimable due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '26.81', 'upperLimit': 'NA'}, {'value': '39.49', 'comment': 'UL for 95% CI Not estimable due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '33.48', 'upperLimit': 'NA'}, {'value': '39.79', 'comment': 'UL for 95% CI Not estimable due to insufficient number of events.', 'groupId': 'OG002', 'lowerLimit': '30.92', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.41', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.22', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.48', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization untill death (up to approximately 61 months)', 'description': 'Overall Survival (OS) for all randomized participants is the time between randomization and the date of death from any cause based on Kaplan-Meier estimates. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who are randomized to any treatment arm in the study.'}, {'type': 'SECONDARY', 'title': 'Arm B Vs Arm C and Arm A Vs Arm B- Progression-Free Survival (Irrespective of Subsequent Therapy) by RECIST 1.1 Per Blinded Independent Central Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.82', 'groupId': 'OG000', 'lowerLimit': '12.58', 'upperLimit': '22.05'}, {'value': '17.38', 'groupId': 'OG001', 'lowerLimit': '14.09', 'upperLimit': '22.14'}, {'value': '15.67', 'groupId': 'OG002', 'lowerLimit': '13.77', 'upperLimit': '20.83'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.05', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.42', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Progression-Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) by BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '61.8', 'upperLimit': '73.0'}, {'value': '72.2', 'groupId': 'OG001', 'lowerLimit': '66.9', 'upperLimit': '77.0'}, {'value': '64.5', 'groupId': 'OG002', 'lowerLimit': '58.9', 'upperLimit': '69.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in ORR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '10.6', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in ORR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '0.7', 'ciUpperLimit': '14.8', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in ORR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '2.5', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Objective Response Rate (ORR) is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nComplete 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.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR) by RECIST 1.1 Per BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.76', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '47.9'}, {'value': '31.84', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '44.3'}, {'value': '25.17', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '44.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per BICR assessment, or death due to any cause, whichever occurs first.\n\nComplete 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.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) by RECIST 1.1 Per BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.92', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '22.2'}, {'value': '2.96', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '41.9'}, {'value': '2.92', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '24.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per BICR.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\n\nComplete 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.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) by RECIST 1.1 Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.82', 'groupId': 'OG000', 'lowerLimit': '13.83', 'upperLimit': '20.40'}, {'value': '17.71', 'groupId': 'OG001', 'lowerLimit': '13.83', 'upperLimit': '24.71'}, {'value': '16.53', 'groupId': 'OG002', 'lowerLimit': '13.77', 'upperLimit': '19.38'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.23', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.05', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.44', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on Investigator assessments (per RECIST v1.1), or death due to any cause, whichever occurs first Calculated using Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) by RECIST 1.1 Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000', 'lowerLimit': '55.4', 'upperLimit': '67.0'}, {'value': '63.1', 'groupId': 'OG001', 'lowerLimit': '57.6', 'upperLimit': '68.4'}, {'value': '57.9', 'groupId': 'OG002', 'lowerLimit': '52.2', 'upperLimit': '63.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in ORR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '11.1', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in ORR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.4', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '12.9', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in ORR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-9.5', 'ciUpperLimit': '5.6', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by investigator assessment per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nComplete 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.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) by RECIST 1.1 Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.83', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '47.4'}, {'value': '33.18', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '47.6'}, {'value': '27.93', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '46.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per investigator assessment, or death due to any cause, whichever occurs first.\n\nComplete 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.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) by RECIST 1.1 Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '25.2'}, {'value': '2.92', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '16.5'}, {'value': '2.89', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '22.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per investigator assessment.\n\nComplete 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.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Death or Distant Metastases (TDDM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.65', 'comment': 'UL of 95% CI not estimable due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': '22.57', 'upperLimit': 'NA'}, {'value': '36.14', 'comment': 'UL of 95% CI not estimable due to insufficient number of events', 'groupId': 'OG001', 'lowerLimit': '25.86', 'upperLimit': 'NA'}, {'value': '30.36', 'groupId': 'OG002', 'lowerLimit': '21.62', 'upperLimit': '40.15'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.23', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.06', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.49', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until metastases or death, whichever occurs first (up to approximately 61 months)', 'description': 'Time to Death or Distant Metastases (TDDM) is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis based on Kaplan-Meier estimates. Distant metastasis is defined as any new lesion that is outside of the thorax (except for heart) according to RECIST 1.1, as assessed by the Investigator.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'title': 'ADVERSE EVENTS', 'categories': [{'measurements': [{'value': '279', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '312', 'groupId': 'OG002'}]}]}, {'title': 'SERIOUS ADVERSE EVENTS', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}]}, {'title': 'GASTROINTESTINAL ADVERSE EVENT', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'HEPATIC ADVERSE EVENT', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'PULMONARY ADVERSE EVENT', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}, {'title': 'RENAL ADVERSE EVENT', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'SKIN ADVERSE EVENT', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}]}, {'title': 'HYPERSENSITIVITY/INFUSION REACTION', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose (Day 1) till 30 days after the last dose (up to approximately 19 months)', 'description': 'An Adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Non-small Cell Lung Cancer (NSCLC)-Symptom Assessment Questionnaire (SAQ) Total Score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'OG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'OG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.60', 'spread': '3.260', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '3.507', 'groupId': 'OG001'}, {'value': '-0.89', 'spread': '3.731', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 48', 'description': 'The NSCLC-SAQ is a questionnaire used in clinical trials to understand how non-small cell lung cancer (NSCLC) affects your daily life and well-being. It has 7 questions that ask about your symptoms over the past 7 days, including cough, pain, shortness of breath, fatigue, and appetite loss. The total scores from the questionnaire range from 0 to 20. A higher score means you have more severe symptoms and are feeling worse, which is a bad outcome. A lower score means you have fewer symptoms and are feeling better, which is a good outcome.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Only participants with data available at the specified timepoint are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'FG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'FG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}, {'groupId': 'FG001', 'numSubjects': '320'}, {'groupId': 'FG002', 'numSubjects': '318'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '138'}, {'groupId': 'FG002', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '182'}, {'groupId': 'FG002', 'numSubjects': '174'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}, {'value': '925', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A:Nivo + CCRT/Nivo + Ipi', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.'}, {'id': 'BG001', 'title': 'Arm B: Nivo + CCRT/Nivo', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.'}, {'id': 'BG002', 'title': 'Arm C: CCRT/Durva', 'description': 'Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.7', 'spread': '8.99', 'groupId': 'BG000'}, {'value': '63.7', 'spread': '8.50', 'groupId': 'BG001'}, {'value': '63.9', 'spread': '9.18', 'groupId': 'BG002'}, {'value': '63.8', 'spread': '8.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '703', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '479', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '354', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '317', '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': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '578', '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': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-30', 'size': 5341963, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-17T08:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 925}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-05', 'studyFirstSubmitDate': '2019-07-18', 'resultsFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2019-07-18', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-05', 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR)', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months)', 'description': 'Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization untill death (up to approximately 61 months)', 'description': 'Overall Survival (OS) for all randomized participants is the time between randomization and the date of death from any cause based on Kaplan-Meier estimates. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.'}, {'measure': 'Arm B Vs Arm C and Arm A Vs Arm B- Progression-Free Survival (Irrespective of Subsequent Therapy) by RECIST 1.1 Per Blinded Independent Central Review (BICR)', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Progression-Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Objective Response Rate (ORR) by BICR', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Objective Response Rate (ORR) is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nComplete 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.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Duration of Response (DoR) by RECIST 1.1 Per BICR', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per BICR assessment, or death due to any cause, whichever occurs first.\n\nComplete 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.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Time to Response (TTR) by RECIST 1.1 Per BICR', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per BICR.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\n\nComplete 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.'}, {'measure': 'Progression Free Survival (PFS) by RECIST 1.1 Per Investigator Assessment', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on Investigator assessments (per RECIST v1.1), or death due to any cause, whichever occurs first Calculated using Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Objective Response Rate (ORR) by RECIST 1.1 Per Investigator Assessment', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by investigator assessment per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nComplete 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.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Duration of Response (DOR) by RECIST 1.1 Per Investigator Assessment', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per investigator assessment, or death due to any cause, whichever occurs first.\n\nComplete 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.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Time to Response (TTR) by RECIST 1.1 Per Investigator Assessment', 'timeFrame': 'From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)', 'description': 'Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per investigator assessment.\n\nComplete 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.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Time to Death or Distant Metastases (TDDM)', 'timeFrame': 'From randomization until metastases or death, whichever occurs first (up to approximately 61 months)', 'description': 'Time to Death or Distant Metastases (TDDM) is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis based on Kaplan-Meier estimates. Distant metastasis is defined as any new lesion that is outside of the thorax (except for heart) according to RECIST 1.1, as assessed by the Investigator.'}, {'measure': 'Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs', 'timeFrame': 'From first dose (Day 1) till 30 days after the last dose (up to approximately 19 months)', 'description': 'An Adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.'}, {'measure': 'Change From Baseline in Non-small Cell Lung Cancer (NSCLC)-Symptom Assessment Questionnaire (SAQ) Total Score at Week 48', 'timeFrame': 'Baseline (Day 1) and Week 48', 'description': 'The NSCLC-SAQ is a questionnaire used in clinical trials to understand how non-small cell lung cancer (NSCLC) affects your daily life and well-being. It has 7 questions that ask about your symptoms over the past 7 days, including cough, pain, shortness of breath, fatigue, and appetite loss. The total scores from the questionnaire range from 0 to 20. A higher score means you have more severe symptoms and are feeling worse, which is a bad outcome. A lower score means you have fewer symptoms and are feeling better, which is a good outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer (NSCLC)']}, 'referencesModule': {'references': [{'pmid': '34489161', 'type': 'DERIVED', 'citation': 'De Ruysscher D, Ramalingam S, Urbanic J, Gerber DE, Tan DSW, Cai J, Li A, Peters S. CheckMate 73L: A Phase 3 Study Comparing Nivolumab Plus Concurrent Chemoradiotherapy Followed by Nivolumab With or Without Ipilimumab Versus Concurrent Chemoradiotherapy Followed by Durvalumab for Previously Untreated, Locally Advanced Stage III Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2022 May;23(3):e264-e268. doi: 10.1016/j.cllc.2021.07.005. Epub 2021 Jul 19.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n* Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.\n* Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease\n\nExclusion Criteria:\n\n* Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation\n* Active infection requiring systemic therapy within 14 days prior to randomization\n* History of organ or tissue transplant that requires systemic use of immune suppressive agents\n* Prior thoracic radiotherapy\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04026412', 'acronym': 'CheckMate73L', 'briefTitle': 'A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)', 'orgStudyIdInfo': {'id': 'CA209-73L'}, 'secondaryIdInfos': [{'id': '2019-001222-98', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: nivolumab + CCRT + ipilimumab', 'description': 'Concurrent chemoradiotherapy (CCRT)', 'interventionNames': ['Biological: nivolumab', 'Biological: ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: nivolumab + CCRT', 'description': 'Concurrent chemoradiotherapy (CCRT)', 'interventionNames': ['Biological: nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: CCRT + durvalumab', 'description': 'Concurrent chemoradiotherapy (CCRT)', 'interventionNames': ['Biological: durvalumab']}], 'interventions': [{'name': 'nivolumab', 'type': 'BIOLOGICAL', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm A: nivolumab + CCRT + ipilimumab', 'Arm B: nivolumab + CCRT']}, {'name': 'ipilimumab', 'type': 'BIOLOGICAL', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm A: nivolumab + CCRT + ipilimumab']}, {'name': 'durvalumab', 'type': 'BIOLOGICAL', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm C: CCRT + durvalumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 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