Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
3期
已完成
NCT03088540
| 适应症 | Carcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell, Non-small-cell Lung Carcinoma, Nonsmall Cell Lung Cancer |
|---|
| 分期 | 3期 |
|---|
| 申办方 | Regeneron Pharmaceuticals |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 712 人 |
|---|
| 干预（药物） | Pemetrexed, Paclitaxel, Gemcitabine, Cisplatin, Carboplatin |
|---|
| 开始日期 | 2017年5月29日 |
|---|
| 完成日期 | 2025年4月18日 |
|---|
| 结果公布日 | 2026年6月25日 |
|---|
摘要
The primary objectives of the study are: * To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells * To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies
Overall Survival (OS)
Up to 94 months · months
| Cemiplimab | 23.4 months |
|---|
| Chemotherapy | 13.7 months |
|---|
| p-value | <0.0001 |
|---|
| Hazard Ratio (HR) | 0.661 (95% CI 0.553–0.790) |
|---|
Progression-free Survival (PFS) Per Blinded IRC
Up to 94 months · months
| Cemiplimab | 6.3 months |
|---|
| Chemotherapy | 5.3 months |
|---|
| p-value | <0.0001 |
|---|
| Hazard Ratio (HR) | 0.559 (95% CI 0.469–0.665) |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
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。