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Clinical trial · no report yet · Phase 1/Phase 2
KEYNOTE-021
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)
- NCT02039674 ↗
- Completed
- Merck Sharp & Dohme LLC
- Focused
We haven't built an HCP commentary report on KEYNOTE-021 (pembrolizumab; pembrolizumab plus ipilimumab; pembrolizumab plus erlotinib in locally advanced or metastatic non-small cell lung carcinoma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on KEYNOTE-021 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 6 | |
| Podcasts | 1 |
The trial
ClinicalTrials.gov- 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
- Phase
- Phase 1/Phase 2
- Status
- Completed
- Conditions
- Non-small Cell Lung Carcinoma
- Interventions
- Pembrolizumab; Paclitaxel; Carboplatin; Bevacizumab; Pemetrexed; Ipilimumab; Erlotinib; Gefitinib
- Arms
- Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C]) · Experimental
- Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B]) · Experimental
- Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C) · Experimental
- Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I]) · Experimental
- Part 1 Cohort E (Pembro 2mg/kg+Erlotinib) · Experimental
- Part 1 Cohort F (Pembro 2mg/kg+Gefitinib) · Experimental
- Part 2 Cohort G+ (Pembro 200mg+C+Pe) · Experimental
- Part 2 Cohort H (Pembro+I) · Experimental
- Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C]) · Experimental
- Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B]) · Experimental
- Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C) · Experimental
- Part 2 Cohort G- (Placebo+C+Pe) · Experimental
- Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I]) · Experimental
- Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I]) · Experimental
- Enrollment
- 267
- Primary outcomes
- Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)
- Part 2 Cohorts D4 and H: Objective Response Rate (ORR)
- All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
- Sponsor
- Merck Sharp & Dohme LLC
- Start
- Feb 21, 2014
- Primary completion
- Nov 7, 2016
- Results posted
- Yes
- Registry record
- NCT02039674 · updated Nov 8, 2022
Publications
linked from the registry- 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. PubMed 27745820
- 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. PubMed 30138764
- 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. PubMed 37465924
- 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. PubMed 30529597
- 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. PubMed 30429032