Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
3期
进行中（已停止招募）
NCT02811861
| 适应症 | Renal Cell Carcinoma |
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| 分期 | 3期 |
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| 申办方 | Eisai Inc. |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 1,069 人 |
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| 干预（药物） | Lenvatinib, Everolimus, Pembrolizumab, Sunitinib |
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| 开始日期 | 2016年10月13日 |
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| 完成日期 | 2020年8月28日 |
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| 结果公布日 | 2021年9月24日 |
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摘要
The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review \[IIR\] using Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).
Progression-free Survival (PFS) by Independent Imaging Review (IIR)
From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) · months
| Lenvatinib 18 mg Plus Everolimus 5 mg | 14.7 months |
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| Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 23.9 months |
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| Sunitinib 50 mg | 9.2 months |
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| p-value | <0.0001 |
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| Stratified Hazard Ratio | 0.65 (95% CI 0.53–0.80) |
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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。