Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
Amgen
450 participants
Jul 17, 2024
INTERVENTIONAL
Conditions
Summary
The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.
Eligibility
Inclusion Criteria5
- Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
- Central laboratory detection of KRAS p.G12C mutation.
- Measurable metastatic disease per RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
- Adequate organ function.
Exclusion Criteria4
- Active, untreated brain metastases.
- Leptomeningeal disease
- Previous treatment with a KRAS p.G12C inhibitor
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan
Interventions
Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
Immediate-release solid dosage form administered orally.
Administered via IV infusion Q2W.
Administered via IV infusion Q2W.
Locations(284)
View Full Details on ClinicalTrials.gov
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NCT06252649