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)

Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy or immunotherapy in participants with unresectable or metastatic non-small cell lung cancer (NSCLC).

Timeline

Start

2014-02-21

Primary completion

2016-11-07

Completion

2021-10-18

Outcome

Mixed primary results

registry Part 2 Cohort G+ (Pembro 200 mg+Pe+C) vs Part 2 Cohort G- (Placebo+Pe+C); p = 0.0016; Difference in Percentages 26.3 NCT02039674 ↗

registry NUMBER Part 2 Cohort G+ (Pembro 200 mg+Pe+C): 55.0 (41.6 to 67.9) Percentage of Participants NCT02039674 ↗

registry NUMBER Part 2 Cohorts D4 & H (Pembro 2mg/kg+I): 29.5 (16.8 to 45.2) Percentage of Participants NCT02039674 ↗

Publications

• Results 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.
• Results 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.
• 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.
• 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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Carboplatin	Small molecule	5 unknown	Intravenous
Subject	Carboplatin	Small molecule	6 unknown	Intravenous
Subject	Erlotinib	Small molecule	150 mg	Oral
Subject	Gefitinib	Small molecule	250 mg	Oral
Subject	Ipilimumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Ipilimumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	2 mg/kg	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Indications