Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
3상
완료
NCT03409614
| 대상 질환 | Non-small 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 | 789 명 |
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| 중재(약물) | REGN2810, REGN2810/chemo/ipi, Chemotherapy |
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| 시작일 | 2018년 3월 6일 |
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| 완료일 | 2025년 2월 27일 |
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| 결과 공개일 | 2026년 4월 29일 |
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요약
The primary objectives of this study are: Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression. The key secondary objectives are: Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
Part 1: Overall Survival (OS)
Up to a maximum of 82.2 months · months
| Part 1: Cemiplimab + Chemotherapy | 15.9 months |
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| Part 1: Cemiplimab+AbbrevChemo+Ipilimumab | 20.1 months |
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| Part 1: Chemotherapy | 13.9 months |
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| p-value | 0.1782 |
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| Hazard Ratio (HR) | 0.813 (95% CI 0.601–1.100) |
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Part 2: OS
Up to a maximum of 68.4 months · months
| Part 2: Cemiplimab + Chemotherapy | 21.1 months |
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| Part 2: Placebo + Chemotherapy | 12.9 months |
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| p-value | 0.0002 |
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| Hazard Ratio (HR) | 0.662 (95% CI 0.531–0.825) |
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BENITIONS에서 보기
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