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)
3期
已完成
NCT03976323
| 适应症 | Carcinoma, Nonsquamous Non-small-cell Lung |
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| 分期 | 3期 |
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| 申办方 | Merck Sharp & Dohme LLC |
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| 状态 | 已完成 |
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| 受试者人数 | 1,003 人 |
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| 干预（药物） | Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin, Olaparib |
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| 开始日期 | 2019年6月28日 |
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| 完成日期 | 2024年2月7日 |
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| 结果公布日 | 2025年2月6日 |
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摘要
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 |
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| Hazard Ratio (HR) | 1.12 (95% CI 0.92–1.36) |
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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 |
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| Hazard Ratio (HR) | 1.04 (95% CI 0.87–1.25) |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。