Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)
Summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).
Timeline
- Start
- 2019-06-28
- Primary completion
- 2024-02-07
- Completion
- 2026-01-30
Outcome
Missed primary endpoint
registry p = 0.8721; Hazard Ratio (HR) 1.12 (95% CI 0.92 to 1.36) NCT03976323 ↗
registry p = 0.6649; Hazard Ratio (HR) 1.04 (95% CI 0.87 to 1.25) NCT03976323 ↗
release “KEYLYNK-006 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, did not meet its dual primary endpoints” merck.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |