{"preliminary_commentary":{"by_channel":{"x_thread":6,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["pembrolizumab"],["pembrolizumab","ipilimumab"],["pembrolizumab","erlotinib"]],"indication":"locally advanced or metastatic non-small cell lung carcinoma","name":"KEYNOTE-021","nct_id":"NCT02039674","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-021-nct02039674. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Cohort A participants receive pembrolizumab (2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (Aare Under the Curve \\[AUC\\] 6 \\[6 mg/mL/min\\]) via IV infusion on Day 1 of each 3-week cycle.","label":"Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C])","type":"EXPERIMENTAL"},{"description":"Cohort B2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 \\[6 mg/mL/min\\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.","label":"Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])","type":"EXPERIMENTAL"},{"description":"Cohort C2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m\\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 \\[5 mg/mL/min\\]) via IV infusion on Day 1 of each 3-week cycle.","label":"Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C)","type":"EXPERIMENTAL"},{"description":"Cohort D1 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.","label":"Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])","type":"EXPERIMENTAL"},{"description":"Cohort E participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (150 mg) via oral tablet 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D).","label":"Part 2 Cohort H (Pembro+I)","type":"EXPERIMENTAL"},{"description":"Cohort A10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 \\[mg/mL/min\\]) via IV infusion on Day 1 of each 3-week cycle.","label":"Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C])","type":"EXPERIMENTAL"},{"description":"Cohort B10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 \\[6 mg/mL/min\\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.","label":"Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B])","type":"EXPERIMENTAL"},{"description":"Cohort C10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m\\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 \\[5 mg/mL/min\\]) via IV infusion on Day 1 of each 3-week cycle.","label":"Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C)","type":"EXPERIMENTAL"},{"description":"Cohort G- participants receive placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 \\[5 mg/mL/min\\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m\\^2) via IV infusion on Day 1 of each 3-week cycle PLUS.","label":"Part 2 Cohort G- (Placebo+C+Pe)","type":"EXPERIMENTAL"},{"description":"Cohort D2 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.","label":"Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I])","type":"EXPERIMENTAL"},{"description":"Cohort D1 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.","label":"Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I])","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2021-10-18","type":"ACTUAL"},"conditions":["Non-small Cell Lung Carcinoma"],"enrollment":{"count":267,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475","KEYTRUDA®","SCH 900475"],"type":"BIOLOGICAL"},{"name":"Paclitaxel","otherNames":["ABRAXANE®"],"type":"DRUG"},{"name":"Carboplatin","otherNames":["PARAPLATIN®"],"type":"DRUG"},{"name":"Bevacizumab","otherNames":["AVASTIN®"],"type":"BIOLOGICAL"},{"name":"Pemetrexed","otherNames":["ALIMTA®"],"type":"DRUG"},{"name":"Ipilimumab","otherNames":["YERVOY®"],"type":"BIOLOGICAL"},{"name":"Erlotinib","otherNames":["TARCEVA®"],"type":"DRUG"},{"name":"Gefitinib","otherNames":["IRESSA®"],"type":"DRUG"}],"last_update":"2022-11-08","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase I/II Study of MK-3475 (SCH900475) in Combination With Chemotherapy or Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2016-11-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)","timeFrame":"Up to approximately 2 years"},{"measure":"Part 2 Cohorts D4 and H: Objective Response Rate (ORR)","timeFrame":"Up to approximately 2 years"},{"measure":"All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)","timeFrame":"Cycle 1 (Up to 21 days)"}],"references":[{"citation":"Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508. doi: 10.1016/S1470-2045(16)30498-3. Epub 2016 Oct 10.","pmid":"27745820","type":"RESULT"},{"citation":"Borghaei H, Langer CJ, Gadgeel S, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Saraf S, Keller SM, Gandhi L. 24-Month Overall Survival from KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin with or without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous Non-Small Cell Lung Cancer. J Thorac Oncol. 2019 Jan;14(1):124-129. doi: 10.1016/j.jtho.2018.08.004. Epub 2018 Aug 21.","pmid":"30138764","type":"RESULT"},{"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":"37465924","type":"DERIVED"},{"citation":"Yang JC, Gadgeel SM, Sequist LV, Wu CL, Papadimitrakopoulou VA, Su WC, Fiore J, Saraf S, Raftopoulos H, Patnaik A. Pembrolizumab in Combination With Erlotinib or Gefitinib as First-Line Therapy for Advanced NSCLC With Sensitizing EGFR Mutation. J Thorac Oncol. 2019 Mar;14(3):553-559. doi: 10.1016/j.jtho.2018.11.028. Epub 2018 Dec 4.","pmid":"30529597","type":"DERIVED"},{"citation":"Gadgeel SM, Stevenson JP, Langer CJ, Gandhi L, Borghaei H, Patnaik A, Villaruz LC, Gubens M, Hauke R, Yang JC, Sequist LV, Bachman R, Saraf S, Raftopoulos H, Papadimitrakopoulou V. Pembrolizumab and platinum-based chemotherapy as first-line therapy for advanced non-small-cell lung cancer: Phase 1 cohorts from the KEYNOTE-021 study. Lung Cancer. 2018 Nov;125:273-281. doi: 10.1016/j.lungcan.2018.08.019. Epub 2018 Aug 25.","pmid":"30429032","type":"DERIVED"}],"start_date":{"date":"2014-02-21"},"study_type":"INTERVENTIONAL","title":"A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)","url":"https://clinicaltrials.gov/study/NCT02039674"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/keynote-021-nct02039674"}