Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy
2/3期
进行中(已停止招募)
NCT04655976
| 适应症 | Lung Cancer, Non-Small Cell |
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| 分期 | 2/3期 |
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| 申办方 | GlaxoSmithKline |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 758 人 |
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| 干预(药物) | Cobolimab, Dostarlimab, Docetaxel |
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| 开始日期 | 2020年12月8日 |
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| 完成日期 | 2025年6月5日 |
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| 结果公布日 | 2026年7月1日 |
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摘要
This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.
Overall Survival (OS) (Arm A Versus Arm C)
Up to approximately 234 weeks · Months
| Cobolimab + Dostarlimab + Docetaxel (Arm A) | 11.9 Months |
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| Docetaxel (Arm C) | 11.3 Months |
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| p-value | 0.079708 |
| Hazard Ratio (HR) | 0.85 (95% CI 0.68–1.06) |
Overall Survival (OS) (Arm B Versus Arm C)
Up to approximately 234 weeks · Months
| Dostarlimab + Docetaxel (Arm B) | 11.8 Months |
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| Docetaxel (Arm C) | 11.3 Months |
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| p-value | 0.369509 |
| Hazard Ratio (HR) | 0.96 (95% CI 0.77–1.20) |
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