Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT02775435
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2016-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)
Sponsor:
Organization:
Raw JSON
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Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 83 months', 'description': 'All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \\& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.', 'eventGroups': [{'id': 'EG000', 'title': 'Pembrolizumab + Chemotherapy Combo', 'description': "Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.", 'otherNumAtRisk': 278, 'deathsNumAtRisk': 278, 'otherNumAffected': 270, 'seriousNumAtRisk': 278, 'deathsNumAffected': 225, 'seriousNumAffected': 128}, {'id': 'EG001', 'title': 'Placebo + Chemotherapy', 'description': "Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.", 'otherNumAtRisk': 280, 'deathsNumAtRisk': 281, 'otherNumAffected': 272, 'seriousNumAtRisk': 280, 'deathsNumAffected': 143, 'seriousNumAffected': 114}, {'id': 'EG002', 'title': 'Placebo Switched Over to Pembrolizumab', 'description': "Participants who received saline placebo with chemotherapy and who experienced disease progression, switched over to receive pembrolizumab monotherapy at investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for 35 cycles (\\~ 2 years).", 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 90, 'seriousNumAtRisk': 118, 'deathsNumAffected': 111, 'seriousNumAffected': 35}, {'id': 'EG003', 'title': 'Pembrolizumab Combo (Second Course)', 'description': "Participants who completed the first course of up to 35 administrations of pembrolizumab (\\~2 years) and were deemed to be benefitting clinically despite progression, received a second course of pembrolizumab at the investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to \\~1 year additional).", 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 6, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Placebo Switched Over to Pembrolizumab (Second Course)', 'description': "Participants who switched from saline placebo to complete the first course of up to 35 administrations of pembrolizumab (\\~2 years), initiated a second course of pembrolizumab at investigator's discretion. Pembrolizumab was administered 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to \\~1 year).", 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 200, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 186, 'numAffected': 139}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 26, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 46, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 40, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 201, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 166, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 131, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 95, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 36, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 93, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 74, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 141, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 86, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 151, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 136, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 71, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 47, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 83, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 72, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 92, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 102, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 45, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 41, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Stoma site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 30, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 39, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 40, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 12, 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0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonitis aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arterial disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Superficial vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thrombophlebitis migrans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy Combo', 'description': "Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\\~ 1 year additional)."}, {'id': 'OG001', 'title': 'Placebo + Chemotherapy', 'description': "Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\\~ 1 year additional)."}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '8.3'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '5.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.70', 'pValueComment': 'Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \\[TPS\\] ≥1% vs. \\<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \\& geographic region (East Asia vs. non-East Asia)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 19 months', 'description': 'PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 is presented.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy Combo', 'description': "Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\\~ 1 year additional)."}, {'id': 'OG001', 'title': 'Placebo + Chemotherapy', 'description': "Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\\~ 1 year additional)."}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'comment': 'NA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': 'NA'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '14.8'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.85', 'pValueComment': 'Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \\[TPS\\] ≥1% vs. \\<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \\& geographic region (East Asia vs. non-East Asia)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 19 months', 'description': 'OS was defined as the time from randomization to death due to any cause. OS is presented.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy Combo', 'description': "Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\\~ 1 year additional)."}, {'id': 'OG001', 'title': 'Placebo + Chemotherapy', 'description': "Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\\~ 1 year additional)."}], 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000', 'lowerLimit': '51.9', 'upperLimit': '63.8'}, {'value': '38.4', 'groupId': 'OG001', 'lowerLimit': '32.7', 'upperLimit': '44.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 19 months', 'description': 'ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by RECIST 1.1. ORR as assessed by blinded independent central review per RECIST 1.1 is presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy Combo', 'description': "Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\\~ 1 year additional)."}, {'id': 'OG001', 'title': 'Placebo + Chemotherapy', 'description': "Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\\~ 1 year additional)."}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '14.7'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '15.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 19 months', 'description': 'For participants who demonstrated a confirmed response (Complete Response \\[CR\\]: Disappearance of all target lesions or Partial Response \\[PR\\]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression as assessed by RECIST 1.1 or death. DOR as assessed by blinded independent central review per RECIST 1.1 is presented.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy Combo', 'description': "Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\\~ 1 year additional)."}, {'id': 'OG001', 'title': 'Placebo + Chemotherapy', 'description': "Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\\~ 1 year additional)."}], 'classes': [{'categories': [{'measurements': [{'value': '274', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 83 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced an AE is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population consisted of all participants who received ≥1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Chemotherapy Combo', 'description': "Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\\~ 1 year additional)."}, {'id': 'OG001', 'title': 'Placebo + Chemotherapy', 'description': "Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\\~ 1 year additional)."}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 29 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE was presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population consisted of all participants who received ≥1 dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pembrolizumab + Chemotherapy Combo', 'description': "Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\\~ 1 year additional)."}, {'id': 'FG001', 'title': 'Placebo + Chemotherapy', 'description': "Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\\~ 1 year additional)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '278'}, {'groupId': 'FG001', 'numSubjects': '281'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '278'}, {'groupId': 'FG001', 'numSubjects': '280'}]}, {'type': 'Received Second Course of Pembrolizumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Received Switch-over Plus Second Course of Pembrolizuamb', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Switched to Pembrolizumab + Chemotherapy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '278'}, {'groupId': 'FG001', 'numSubjects': '281'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '224'}]}]}], 'preAssignmentDetails': 'Per protocol, response/progression, or adverse events during the second and switch-over pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '559', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pembrolizumab + Chemotherapy Combo', 'description': "Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\\~ 1 year additional)."}, {'id': 'BG001', 'title': 'Placebo + Chemotherapy', 'description': "Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\\~ 1 year additional)."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '64.8', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '64.9', 'spread': '8.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '455', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '430', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS)', 'classes': [{'categories': [{'title': 'TPS <1%', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}, {'title': 'TPS ≥1%', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '353', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Participants with a TPS ≥1% were classified as PD-L1 positive and participants with a TPS \\<1% were classified as not PD-L1 positive.', 'unitOfMeasure': 'Participants'}, {'title': 'Taxane Chemotherapy', 'classes': [{'categories': [{'title': '+Paclitaxel', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}, {'title': '+Nab-paclitaxel', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were classified according to their taxane chemotherapy regimen: paclitaxel or nab-paclitaxel.', 'unitOfMeasure': 'Participants'}, {'title': 'Geographic Region', 'classes': [{'categories': [{'title': 'East Asia', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Non-East Asia', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were classified according to their geographic region: East Asia vs. non-East Asia.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-25', 'size': 2316622, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-21T08:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 559}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2016-05-15', 'resultsFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2016-05-15', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-18', 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 19 months', 'description': 'PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 is presented.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 19 months', 'description': 'OS was defined as the time from randomization to death due to any cause. OS is presented.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 19 months', 'description': 'ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by RECIST 1.1. ORR as assessed by blinded independent central review per RECIST 1.1 is presented.'}, {'measure': 'Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 19 months', 'description': 'For participants who demonstrated a confirmed response (Complete Response \\[CR\\]: Disappearance of all target lesions or Partial Response \\[PR\\]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression as assessed by RECIST 1.1 or death. DOR as assessed by blinded independent central review per RECIST 1.1 is presented.'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to approximately 83 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced an AE is presented.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)', 'timeFrame': 'Up to approximately 29 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE was presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death-1 (PD1, PD-1)', 'Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)', 'Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40498298', 'type': 'DERIVED', 'citation': 'Garassino MC, Cheng Y, Rodriguez-Abreu D, Novello S, Mazieres J, Robinson AG, Powell SF, Halmos B, Gray JE, Wang M, Chen C, Yang J, Souza F, Schwarzenberger P, Paz-Ares L. Impact of Tumor Response and Response Duration on Survival Among Participants Receiving Pembrolizumab Plus Chemotherapy as First-Line Therapy for Non-Small-Cell Lung Cancer. Oncol Ther. 2025 Sep;13(3):667-681. doi: 10.1007/s40487-025-00350-6. Epub 2025 Jun 11.'}, {'pmid': '37465924', 'type': 'DERIVED', 'citation': 'Cheng Y, Yang JC, Okamoto I, Zhang L, Hu J, Wang D, Hu C, Zhou J, Wu L, Cao L, Liu J, Zhang H, Sun H, Wang Z, Gao H, Yan Y, Xiao S, Lin J, Pietanza MC, Kurata T. Pembrolizumab plus chemotherapy for advanced non-small-cell lung cancer without tumor PD-L1 expression in Asia. Immunotherapy. 2023 Sep;15(13):1029-1044. doi: 10.2217/imt-2023-0043. Epub 2023 Jul 19.'}, {'pmid': '36793385', 'type': 'DERIVED', 'citation': 'Garassino MC, Gadgeel S, Novello S, Halmos B, Felip E, Speranza G, Hui R, Garon EB, Horinouchi H, Sugawara S, Rodriguez-Abreu D, Reck M, Cristescu R, Aurora-Garg D, Loboda A, Lunceford J, Kobie J, Ayers M, Piperdi B, Pietanza MC, Paz-Ares L. Associations of Tissue Tumor Mutational Burden and Mutational Status With Clinical Outcomes With Pembrolizumab Plus Chemotherapy Versus Chemotherapy For Metastatic NSCLC. JTO Clin Res Rep. 2022 Nov 8;4(1):100431. doi: 10.1016/j.jtocrr.2022.100431. eCollection 2023 Jan.'}, {'pmid': '36735893', 'type': 'DERIVED', 'citation': 'Novello S, Kowalski DM, Luft A, Gumus M, Vicente D, Mazieres J, Rodriguez-Cid J, Tafreshi A, Cheng Y, Lee KH, Golf A, Sugawara S, Robinson AG, Halmos B, Jensen E, Schwarzenberger P, Pietanza MC, Paz-Ares L. Pembrolizumab Plus Chemotherapy in Squamous Non-Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study. J Clin Oncol. 2023 Apr 10;41(11):1999-2006. doi: 10.1200/JCO.22.01990. Epub 2023 Feb 3.'}, {'pmid': '32599071', 'type': 'DERIVED', 'citation': 'Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazieres J, Hermes B, Cicin I, Medgyasszay B, Rodriguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. doi: 10.1016/j.jtho.2020.06.015. Epub 2020 Jun 26.'}, {'pmid': '31751163', 'type': 'DERIVED', 'citation': 'Mazieres J, Kowalski D, Luft A, Vicente D, Tafreshi A, Gumus M, Laktionov K, Hermes B, Cicin I, Rodriguez-Cid J, Wilson J, Kato T, Ramlau R, Novello S, Reddy S, Kopp HG, Piperdi B, Li X, Burke T, Paz-Ares L. Health-Related Quality of Life With Carboplatin-Paclitaxel or nab-Paclitaxel With or Without Pembrolizumab in Patients With Metastatic Squamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2020 Jan 20;38(3):271-280. doi: 10.1200/JCO.19.01348. Epub 2019 Nov 21.'}, {'pmid': '30280635', 'type': 'DERIVED', 'citation': 'Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gumus M, Mazieres J, Hermes B, Cay Senler F, Csoszi T, Fulop A, Rodriguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. doi: 10.1056/NEJMoa1810865. Epub 2018 Sep 25.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26124&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'This is a study of carboplatin and paclitaxel or nano particle albumin-bound paclitaxel (nab-paclitaxel) with or without pembrolizumab (MK-3475, KEYTRUDA®) in adults with first line metastatic squamous non-small cell lung cancer (NSCLC).\n\nThe primary hypotheses are that treatment with pembrolizumab prolongs: 1) Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by a blinded central imaging vendor compared to placebo, and 2) Overall Survival (OS).\n\nAfter analysis of interim results was conducted, the protocol was amended (Amendment 5) to allow participants the option to discontinue placebo in the control arm and to switch to pembrolizumab in the event of documented progressive disease as assessed by central review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b-American Joint Committee on Cancer \\[AJCC\\] 7th edition) squamous NSCLC.\n* Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.\n* Has not received prior systemic treatment for metastatic NSCLC.\n* Has provided tumor tissue from locations not radiated prior to biopsy.\n* Has a life expectancy of at least 3 months.\n* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.\n* Has adequate organ function.\n* If female of childbearing potential, is willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of study drug.\n* If male with a female partner(s) of child-bearing potential, must agree to use an adequate method of contraception starting with the first dose of study drug through 95 days after the last dose of study drug. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n\nExclusion Criteria:\n\n* Has non-squamous histology NSCLC.\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of pembrolizumab.\n* Before the first dose of study drug: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease; b) Has received other targeted or biological antineoplastic therapy (e.g., erlotinib, crizotinib, cetuximab) for metastatic disease; c) Has had major surgery (\\<3 weeks prior to first dose).\n* Received radiation therapy to the lung that is \\> 30 Gy within 6 months of the first dose of study drug.\n* Completed palliative radiotherapy within 7 days of the first dose of study drug.\n* Is expected to require any other form of antineoplastic therapy while on study.\n* Has received a live-virus vaccination within 30 days of planned treatment start.\n* Has a known history of prior 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* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria.\n* Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody.\n* Has a known sensitivity to any component of carboplatin or paclitaxel or nab-paclitaxel.\n* Has active autoimmune disease that has required systemic treatment in past 2 years.\n* Is on chronic systemic steroids.\n* Had prior treatment with any other anti-programmed cell death 1 (anti-PD-1), or programmed cell death ligand 1 (PD-L1) or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms.\n* Has participated in any other pembrolizumab trial and has been treated with pembrolizumab.\n* Has an active infection requiring therapy.\n* Has known history of Human Immunodeficiency Virus (HIV).\n* Has known active Hepatitis B or C. Active Hepatitis B.\n* Is, at the time of providing documented informed consent, a regular user (including "recreational use") of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol).\n* Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.'}, 'identificationModule': {'nctId': 'NCT02775435', 'briefTitle': 'A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-407)', 'orgStudyIdInfo': {'id': '3475-407'}, 'secondaryIdInfos': [{'id': '173568', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}, {'id': 'MK-3475-407', 'type': 'OTHER', 'domain': 'MSD Protocol Number'}, {'id': 'KEYNOTE-407', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2016-000229-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab + Chemotherapy Combo', 'description': "Participants receive pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin area under the curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.", 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Paclitaxel', 'Drug: Nab-paclitaxel', 'Drug: Carboplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Chemotherapy', 'description': "Participants receive normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles (\\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.", 'interventionNames': ['Drug: Paclitaxel', 'Drug: Nab-paclitaxel', 'Drug: Carboplatin', 'Drug: Saline placebo for pembrolizumab']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475', 'KEYTRUDA®'], 'description': 'IV infusion', 'armGroupLabels': ['Pembrolizumab + Chemotherapy Combo']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['TAXOL®'], 'description': 'IV infusion', 'armGroupLabels': ['Pembrolizumab + Chemotherapy Combo', 'Placebo + Chemotherapy']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'otherNames': ['ABRAXANE®'], 'description': 'IV infusion', 'armGroupLabels': ['Pembrolizumab + Chemotherapy Combo', 'Placebo + Chemotherapy']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['PARAPLATIN®'], 'description': 'IV infusion Carboplatin dose should not to exceed 900 mg.', 'armGroupLabels': ['Pembrolizumab + Chemotherapy Combo', 'Placebo + Chemotherapy']}, {'name': 'Saline placebo for pembrolizumab', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ['Placebo + Chemotherapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}