A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
Summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS). As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
Timeline
- Start
- 2019-06-28
- Primary completion
- 2023-09-21
- Completion
- 2026-01-30
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase); p = 0.0040; Hazard Ratio (HR) 0.77 (95% CI 0.63 to 0.93); reads as mixed primary results NCT03976362 ↗
registry analysis (superiority test); Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase); p = 0.5481; Hazard Ratio (HR) 1.01 (95% CI 0.83 to 1.24); reads as mixed primary results NCT03976362 ↗
release “第3相KEYLYNK−006試験において、2つの主要評価項目である全生存期間（OS）と無増悪生存期間（PFS）を達成しなかったことを発表しました。” reads as missed primary endpoint msd.co.jp ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Nab-paclitaxel | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |