Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
Study NCT ID:
NCT03322566
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2017-10-24
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'France', 'Germany', 'Ukraine']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], 'ancestors': [{'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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'C000613752', 'term': 'epacadostat'}, {'id': 'D017671', 'term': 'Platinum Compounds'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'otherDetails': 'Clinical Study Agreement', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Data from the final analysis of KEYNOTE-715/ECHO-306 (data cutoff: 13-DEC-2018) indicated that the study did not meet the pre-specified endpoint of improvement in objective response rate (ORR).'}}, 'adverseEventsModule': {'timeFrame': 'Up to 25 months', 'description': 'All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Pembrolizumab + Chemotherapy + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 87, 'seriousNumAtRisk': 90, 'deathsNumAffected': 38, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': 'Pembrolizumab + Chemotherapy + Placebo', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 81, 'seriousNumAtRisk': 86, 'deathsNumAffected': 35, 'seriousNumAffected': 41}, {'id': 'EG002', 'title': 'Pembrolizumab + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 51, 'seriousNumAtRisk': 52, 'deathsNumAffected': 26, 'seriousNumAffected': 20}, {'id': 'EG003', 'title': 'Total', 'description': 'Total', 'otherNumAtRisk': 228, 'deathsNumAtRisk': 228, 'otherNumAffected': 219, 'seriousNumAtRisk': 228, 'deathsNumAffected': 99, 'seriousNumAffected': 108}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 35, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 32, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 34, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 56, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 101, 'numAffected': 69}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 39, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 37, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 47, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 37, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 27, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 40, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 35, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 84, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 37, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 57, 'numAffected': 47}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 36, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 35, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 90, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 41, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 18, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 32, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 40, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 32, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 88, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 38, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 17, 'numAffected': 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complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Vocal cord paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 228, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}, {'id': 'OG001', 'title': 'Pembrolizumab + Chemotherapy + Placebo', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '36.7'}, {'value': '44.8', 'groupId': 'OG001', 'lowerLimit': '34.1', 'upperLimit': '55.9'}]}]}], 'analyses': [{'pValue': '0.9948', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.5', 'ciLowerLimit': '-32.0', 'ciUpperLimit': '-4.3', 'pValueComment': 'One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \\> 0.', 'estimateComment': "Stratified by PD-L1 TPS ( \\<50% vs. \\>=50% ) and predominant tumor histology (squamous vs non-squamous);because of small sample size, the strata 'TPS \\>= 50 percent Non-squamous' and 'TPS \\>= 50% Squamous' were combined into one stratum.", 'statisticalMethod': 'Stratified Miettinen and Nurminen method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed every 12 weeks up to 24 months', 'description': 'ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all participants randomized in treatment arm Pembrolizumab+Epacadostat+Chemotherapy and treatment arm Pembrolizumab+Chemothrapy. This is not a primary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}, {'id': 'OG001', 'title': 'Pembrolizumab + Chemotherapy + Placebo', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '10.2'}, {'value': '8.2', 'comment': 'Upper bound is not estimable', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.94305', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '0.91', 'ciUpperLimit': '2.36', 'pValueComment': "One-sided p-value based on log-rank test stratified by TPS (\\<50% vs \\>=50%) and predominant histology (squamous vs non-squamous), because of small sample size, the strata 'TPS \\>= 50% Non-squamous' and 'TPS \\>= 50% Squamous' were combined into one.", 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Efron's method of tie handling"}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 months', 'description': 'Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all participants randomized in treatment arm Pembrolizumab+Epacadostat+Chemotherapy and treatment arm Pembrolizumab+Chemothrapy. This is not a secondary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.'}, {'type': 'SECONDARY', 'title': 'Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}, {'id': 'OG001', 'title': 'Pembrolizumab + Chemotherapy + Placebo', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median could not be estimated because there were not enough events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median could not be estimated because there were not enough events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.96272', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.90', 'ciLowerLimit': '0.93', 'ciUpperLimit': '3.90', 'pValueComment': 'One-sided p-value based on log-rank test stratified by PD-L1 TPS (\\<50% vs \\>=50%) and predominant tumor histology (squamous vs non-squamous), because of small sample size, the strata (\\<50% vs \\>=50%) were combined into one stratum.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 months', 'description': 'Defined as the time from randomization to death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all participants randomized in treatment arm Pembrolizumab+Epacadostat+Chemotherapy and treatment arm Pembrolizumab+Chemothrapy. This is not a secondary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.'}, {'type': 'SECONDARY', 'title': 'Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}, {'id': 'OG001', 'title': 'Pembrolizumab + Chemotherapy + Placebo', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median could not be estimated because there were not enough events', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '7.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 months', 'description': 'Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all participants randomized in treatment arm Pembrolizumab+Epacadostat+Chemotherapy and treatment arm Pembrolizumab+Chemothrapy. This is not a secondary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}, {'id': 'OG001', 'title': 'Pembrolizumab + Chemotherapy + Placebo', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 25 months', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects as Treated consists of all randomized participants who received at least one dose of study treatment. This is not a secondary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}, {'id': 'OG001', 'title': 'Pembrolizumab + Chemotherapy + Placebo', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 25 months', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of any study drug, whether or not considered related to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects as Treated consists of all randomized participants who received at least one dose of study treatment. This is not a secondary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pembrolizumab + Chemotherapy + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}, {'id': 'FG001', 'title': 'Pembrolizumab + Chemotherapy + Placebo', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}, {'id': 'FG002', 'title': 'Pembrolizumab + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 65 investigative sites in 14 countries from 09 January 2018 to 13 December 2018.', 'preAssignmentDetails': 'Phase 3 design of the study has been amended soon after it had started to a prospectively randomized phase 2 study. At the time of amendment existing participants were given a choice to move/participate in the new phase 2 study, and some participants who chose to discontinue the study at phase 3 were assigned to "study terminated by sponsor" as the reason for not completing the study in disposition table. The results posted are combined in the prospectively redesigned phase 2 trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Pembrolizumab + Chemotherapy + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}, {'id': 'BG001', 'title': 'Pembrolizumab + Chemotherapy + Placebo', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).'}, {'id': 'BG002', 'title': 'Pembrolizumab + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '63.6', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '8.4', 'groupId': 'BG002'}, {'value': '63.2', 'spread': '9.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', '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': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Black Or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '223', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all participants who were randomized to study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-04', 'size': 1117205, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-09T12:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2017-10-24', 'resultsFirstSubmitDate': '2019-12-10', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-16', 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo', 'timeFrame': 'Assessed every 12 weeks up to 24 months', 'description': 'ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo', 'timeFrame': 'Up to 24 months', 'description': 'Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.'}, {'measure': 'Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo', 'timeFrame': 'Up to 24 months', 'description': 'Defined as the time from randomization to death due to any cause.'}, {'measure': 'Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo', 'timeFrame': 'Up to 24 months', 'description': 'Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first.'}, {'measure': 'Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)', 'timeFrame': 'Up to 25 months', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.'}, {'measure': 'Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs', 'timeFrame': 'Up to 25 months', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of any study drug, whether or not considered related to the study drug.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer', 'programmed cell death 1 (PD-1) inhibitor', 'indoleamine 2', '3-dioxygenase 1 (IDO1) inhibitor', 'chemotherapy'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '39054462', 'type': 'DERIVED', 'citation': 'Boyer M, Hui R, Urban D, Clingan P, Su WC, Devaux C, Gadgeel S, Garassino M, Leopold L, Daniel J, Munteanu MC, Samkari A, Luo Y, Abreu DR. Pembrolizumab with platinum-based chemotherapy with or without epacadostat as first-line treatment for metastatic non-small cell lung cancer: a randomized, partially double-blind, placebo-controlled phase II study. BMC Cancer. 2024 Jul 25;23(Suppl 1):1250. doi: 10.1186/s12885-022-10427-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation\n* Measurable disease based on RECIST 1.1\n* Life expectancy of at least 3 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function per protocol-defined criteria.\n* Provide tumor tissue sample.\n\nExclusion Criteria:\n\n* Known untreated central nervous system metastases and/or carcinomatous meningitis\n* History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.\n* Symptomatic ascites or pleural effusion.\n* Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.\n* Active autoimmune disease that has required systemic treatment in past 2 years.\n* Has had an allogeneic tissue/solid organ transplant.\n* Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.\n* Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.\n* History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.\n* Use of protocol-defined prior/concomitant therapy."}, 'identificationModule': {'nctId': 'NCT03322566', 'briefTitle': 'A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'KEYNOTE-715-06/ECHO-306-06'}, 'secondaryIdInfos': [{'id': '2017-001810-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab + Chemotherapy + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).', 'interventionNames': ['Drug: Pembrolizumab', 'Drug: Epacadostat', 'Drug: Platinum-based chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab + Chemotherapy + Placebo', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\\^2 IV infusion, Q3W + cisplatin 75 mg/m\\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).', 'interventionNames': ['Drug: Pembrolizumab', 'Drug: Platinum-based chemotherapy', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab + Epacadostat', 'description': 'Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.', 'interventionNames': ['Drug: Pembrolizumab', 'Drug: Epacadostat']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'DRUG', 'otherNames': ['MK-3475'], 'description': 'Pembrolizumab administered intravenously every 3 weeks.', 'armGroupLabels': ['Pembrolizumab + Chemotherapy + Epacadostat', 'Pembrolizumab + Chemotherapy + Placebo', 'Pembrolizumab + Epacadostat']}, {'name': 'Epacadostat', 'type': 'DRUG', 'otherNames': ['INCB024360'], 'description': 'Epacadostat administered orally twice daily.', 'armGroupLabels': ['Pembrolizumab + Chemotherapy + Epacadostat', 'Pembrolizumab + Epacadostat']}, {'name': 'Platinum-based chemotherapy', 'type': 'DRUG', 'description': 'Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.', 'armGroupLabels': ['Pembrolizumab + Chemotherapy + Epacadostat', 'Pembrolizumab + Chemotherapy + Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo administered orally twice daily.', 'armGroupLabels': ['Pembrolizumab + Chemotherapy + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36526', 'city': 'Daphne', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center, PC', 'geoPoint': {'lat': 30.60353, 'lon': -87.9036}}, {'zip': '85338', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Western Regional Medical Center, Inc.', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates PC- HOPE', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Lynn Cancer Institute', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33901-8101', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists (South Region)', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida 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