Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)
3期
已完成
NCT03829332
| 适应症 | Non-small Cell Lung Cancer |
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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 | 623 人 |
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| 干预（药物） | Pembrolizumab, Lenvatinib, Placebo for lenvatinib |
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| 开始日期 | 2019年3月13日 |
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| 完成日期 | 2021年5月19日 |
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| 结果公布日 | 2022年6月2日 |
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摘要
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%. The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to approximately 25 months · Months
| Pembrolizumab + Lenvatinib | 6.6 Months |
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| Pembrolizumab + Placebo | 4.2 Months |
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| p-value | 0.00624 |
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| Hazard Ratio (HR) | 0.78 (95% CI 0.64–0.95) |
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Overall Survival (OS)
Up to approximately 25 months · Months
| Pembrolizumab + Lenvatinib | 14.1 Months |
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| Pembrolizumab + Placebo | 16.4 Months |
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| p-value | 0.79744 |
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| Hazard Ratio (HR) | 1.10 (95% CI 0.87–1.39) |
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