Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
3상
진행 중(모집 완료)
NCT03043872
| 대상 질환 | Small Cell Lung Carcinoma Extensive Disease |
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| 임상 단계 | 3상 |
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| 스폰서 | AstraZeneca |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 987 명 |
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| 중재(약물) | Durvalumab, Tremelimumab, Carboplatin, Cisplatin, Etoposide |
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| 시작일 | 2017년 3월 27일 |
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| 완료일 | 2020년 1월 27일 |
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| 결과 공개일 | 2021년 3월 4일 |
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요약
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer
Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP
From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months). · months
| Global Cohort: D + EP | 13.0 months |
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| Global Cohort: EP | 10.3 months |
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| p-value | 0.0047 |
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| Hazard Ratio (HR) | 0.73 (95% CI 0.591–0.909) |
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OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP
From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). · months
| Global Cohort: D + T + EP | 10.4 months |
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| Global Cohort: D + EP | 12.9 months |
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| Global Cohort: EP | 10.5 months |
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| p-value | 0.0032 |
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| Hazard Ratio (HR) | 0.75 (95% CI 0.625–0.910) |
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OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP
From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months). · months
| China Cohort: D + EP | 14.4 months |
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| China Cohort: EP | 10.9 months |
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| p-value | 0.0664 |
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| Hazard Ratio (HR) | 0.65 (95% CI 0.414–1.029) |
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