Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-03-07 @ 10:56 PM
Study NCT ID:
NCT03348904
Status:
TERMINATED
Last Update Posted:
2019-06-13
First Post:
2017-11-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000077594', 'term': 'Nivolumab'}, {'id': 'C000613752', 'term': 'epacadostat'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1-855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'otherDetails': 'Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.', 'description': 'All treated participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy', 'description': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Platinum Doublet Chemotherapy', 'description': 'Platinum Doublet Chemotherapy included the following:\n\nCarboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy', 'description': 'Nivolumab plus placebo in combination with platinum doublet chemotherapy included:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy', 'description': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}, {'id': 'OG001', 'title': 'Platinum Doublet Chemotherapy', 'description': 'Platinum Doublet Chemotherapy included the following:\n\nCarboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}], 'timeFrame': 'Approximately 38 months', 'description': 'Defined as the time from randomization to the date of death from any cause.', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.'}, {'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy', 'description': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}, {'id': 'OG001', 'title': 'Platinum Doublet Chemotherapy', 'description': 'Platinum Doublet Chemotherapy included the following:\n\nCarboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}], 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first.', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy', 'description': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}, {'id': 'OG001', 'title': 'Platinum Doublet Chemotherapy', 'description': 'Platinum Doublet Chemotherapy included the following:\n\nCarboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}], 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review.', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy', 'description': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}, {'id': 'OG001', 'title': 'Platinum Doublet Chemotherapy', 'description': 'Platinum Doublet Chemotherapy included the following:\n\nCarboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}], 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.'}, {'type': 'SECONDARY', 'title': 'Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy', 'description': 'Nivolumab plus placebo in combination with platinum doublet chemotherapy included:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}], 'timeFrame': 'Approximately 38 months', 'description': 'Defined as the time from randomization to the date of death from any cause.', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.'}, {'type': 'SECONDARY', 'title': 'Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy', 'description': 'Nivolumab plus placebo in combination with platinum doublet chemotherapy included:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}], 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first.', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.'}, {'type': 'SECONDARY', 'title': 'Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy', 'description': 'Nivolumab plus placebo in combination with platinum doublet chemotherapy included:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}], 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review.', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.'}, {'type': 'SECONDARY', 'title': 'Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy', 'description': 'Nivolumab plus placebo in combination with platinum doublet chemotherapy included:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}], 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy', 'description': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}, {'id': 'FG001', 'title': 'Platinum Doublet Chemotherapy', 'description': 'Platinum Doublet Chemotherapy included the following:\n\nCarboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}, {'id': 'FG002', 'title': 'Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy', 'description': 'Nivolumab plus placebo in combination with platinum doublet chemotherapy included:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Administrative reason by the sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Approximately 630 participants were planned to be randomized. Prior to the termination of the study, 2 participants were randomized to the Platinum Doublet Chemotherapy arm (Arm B) and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy', 'description': 'Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}, {'id': 'BG001', 'title': 'Platinum Doublet Chemotherapy', 'description': 'Platinum Doublet Chemotherapy included the following:\n\nCarboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}, {'id': 'BG002', 'title': 'Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy', 'description': 'Nivolumab plus placebo in combination with platinum doublet chemotherapy included:\n\nNivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.\n\nOptional continuation maintenance was available every 3 weeks, if eligible.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2017-10-23', 'size': 1696710, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-12T10:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-12', 'studyFirstSubmitDate': '2017-11-16', 'resultsFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-12', 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)', 'timeFrame': 'Approximately 38 months', 'description': 'Defined as the time from randomization to the date of death from any cause.'}, {'measure': 'Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)', 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)', 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review.'}, {'measure': 'Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)', 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.'}, {'measure': 'Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)', 'timeFrame': 'Approximately 38 months', 'description': 'Defined as the time from randomization to the date of death from any cause.'}, {'measure': 'Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)', 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first.'}, {'measure': 'Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)', 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review.'}, {'measure': 'Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)', 'timeFrame': 'Approximately 25 months', 'description': 'Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer', 'programmed cell death protein 1 (PD-1) antibody', 'indoleamine 2,3-dioxygenase (IDO) inhibitor'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed stage IV or recurrent NSCLC of squamous or non-squamous histology that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy).\n* No prior treatment with systemic anti-cancer therapy for Stage IV disease.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.\n* Measurable disease by computed tomography or magnetic resonance imaging per RECIST v1.1.\n* Documentation of program death ligand-1 (PD-L1) status of 0 to 49% by IHC performed by the central laboratory prior to randomization.\n* Other protocol inclusion criteria may apply\n\nExclusion Criteria:\n\n* Known epidermal growth factor receptor (EGFR) mutations sensitive to available targeted inhibitor therapy.\n* Known ALK or ROS1 rearrangements sensitive to available targeted inhibitor therapy.\n* Untreated central nervous system (CNS) metastases.\n* Unevaluable PD-L1 status or PD-L1 status of ≥ 50% by IHC performed by a central laboratory.\n* Carcinomatous meningitis.\n* Active, known or suspected autoimmune disease.\n* Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, IDO1 targeted agent, or any other antibody or drug targeting T cell co-stimulation or checkpoint pathways.\n* History of allergy or hypersensitivity to platinum-containing compounds or study drug components.\n* Physical and laboratory test findings outside the protocol-defined range.\n* Other protocol exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03348904', 'briefTitle': 'Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'CA2099NC/ECHO-309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Nivolumab plus epacadostat in combination with platinum doublet', 'interventionNames': ['Drug: Nivolumab', 'Drug: Epacadostat', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Gemcitabine', 'Drug: Paclitaxel', 'Drug: Pemetrexed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': 'Platinum doublet chemotherapy', 'interventionNames': ['Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Gemcitabine', 'Drug: Paclitaxel', 'Drug: Pemetrexed']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C', 'description': 'Nivolumab plus placebo in combination with platinum doublet chemotherapy.', 'interventionNames': ['Drug: Nivolumab', 'Drug: Placebo', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Gemcitabine', 'Drug: Paclitaxel', 'Drug: Pemetrexed']}], 'interventions': [{'name': 'Nivolumab', 'type': 'DRUG', 'otherNames': ['BMS-936558'], 'description': 'Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.', 'armGroupLabels': ['Arm A', 'Arm C']}, {'name': 'Epacadostat', 'type': 'DRUG', 'otherNames': ['INCB024360'], 'description': 'Epacadostat administered orally at the protocol-defined dose twice daily.', 'armGroupLabels': ['Arm A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo for epacadostat administered orally twice daily.', 'armGroupLabels': ['Arm C']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cancer Medical Center, Inc', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}], 'overallOfficials': [{'name': 'Sridhar K. Rabindran, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb Research and Development'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}