Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
第3相
完了
NCT03409614
| 対象疾患 | Non-small Cell Lung Cancer |
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| 相 | 第3相 |
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| スポンサー | Regeneron Pharmaceuticals |
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| ステータス | 完了 |
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| 参加者数 | 789 名 |
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| 介入（薬剤） | REGN2810, REGN2810/chemo/ipi, Chemotherapy |
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| 開始日 | 2018年3月6日 |
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| 完了日 | 2025年2月27日 |
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| 結果公開日 | 2026年4月29日 |
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概要
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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すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。