Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
3상
완료
NCT03088540
| 대상 질환 | Carcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell, Non-small-cell Lung Carcinoma, Nonsmall Cell Lung Cancer |
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| 임상 단계 | 3상 |
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| 스폰서 | Regeneron Pharmaceuticals |
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| 상태 | 완료 |
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| 참여자 수 | 712 명 |
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| 중재(약물) | Pemetrexed, Paclitaxel, Gemcitabine, Cisplatin, Carboplatin |
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| 시작일 | 2017년 5월 29일 |
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| 완료일 | 2025년 4월 18일 |
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| 결과 공개일 | 2026년 6월 25일 |
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요약
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 |
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| Chemotherapy | 13.7 months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.661 (95% CI 0.553–0.790) |
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Progression-free Survival (PFS) Per Blinded IRC
Up to 94 months · months
| Cemiplimab | 6.3 months |
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| Chemotherapy | 5.3 months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.559 (95% CI 0.469–0.665) |
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