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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
Trial Status: active
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.
Inclusion Criteria
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 Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT06252649.
