About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- FOLFIRI Regimen
- Sotorasib
- Panitumumab
- Bevacizumab-awwb