Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
Phase 3
Active, not recruiting
NCT03043872
| Condition | Small Cell Lung Carcinoma Extensive Disease |
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| Phase | Phase 3 |
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| Sponsor | AstraZeneca |
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| Status | Active, not recruiting |
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| Enrollment | 987 participants |
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| Interventions | Durvalumab, Tremelimumab, Carboplatin, Cisplatin, Etoposide |
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| Start date | Mar 27, 2017 |
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| Completion date | Jan 27, 2020 |
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| Results posted | Mar 4, 2021 |
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Summary
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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Open in BENITIONS
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