Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Phase 3
Completed
NCT04303780
| Condition | KRAS p, G12c Mutated /Advanced Metastatic NSCLC |
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| Phase | Phase 3 |
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| Sponsor | Amgen |
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| Status | Completed |
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| Enrollment | 345 participants |
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| Interventions | AMG 510, Docetaxel |
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| Start date | Jun 4, 2020 |
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| Completion date | Aug 2, 2022 |
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| Results posted | May 10, 2023 |
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Summary
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
Progression-free Survival (PFS)
Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months · months
| AMG 510 | 5.62 months |
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| Docetaxel | 4.47 months |
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| p-value | 0.002 |
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| Hazard Ratio (HR) | 0.663 (95% CI 0.509–0.864) |
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Open in BENITIONS
View on ClinicalTrials.gov
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