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)
Phase 3
Completed
NCT03976323
| Condition | Carcinoma, Nonsquamous Non-small-cell Lung |
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| Phase | Phase 3 |
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| Sponsor | Merck Sharp & Dohme LLC |
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| Status | Completed |
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| Enrollment | 1,003 participants |
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| Interventions | Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin, Olaparib |
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| Start date | Jun 28, 2019 |
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| Completion date | Feb 7, 2024 |
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| Results posted | Feb 6, 2025 |
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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).
Progression-free Survival (PFS)
Up to ~31 months · Months
| Pembrolizumab + Olaparib (Maintenance Phase) | 7.1 Months |
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| Pembrolizumab + Pemetrexed (Maintenance Phase) | 8.3 Months |
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| p-value | 0.8721 |
| Hazard Ratio (HR) | 1.12 (95% CI 0.92–1.36) |
Overall Survival (OS)
Up to ~51 months · Months
| Pembrolizumab + Olaparib (Maintenance Phase) | 20.7 Months |
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| Pembrolizumab + Pemetrexed (Maintenance Phase) | 23.0 Months |
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| p-value | 0.6649 |
| Hazard Ratio (HR) | 1.04 (95% CI 0.87–1.25) |
Open in BENITIONS
View on ClinicalTrials.gov
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