Study Comparing Sotorasib, Panitumumab, and FOLFIRI to FOLFIRI with or without Bevacizumab-awwb for New Patients with Metastatic Colorectal Cancer with KRAS p.G12C Mutation
Sponsor: Amgen
ClinicalTrials ID:NCT06252649
This clinical trial is evaluating the effectiveness of a new combination of drugs, including Sotorasib and Panitumumab, compared to standard treatments for patients with metastatic colorectal cancer that has a specific KRAS mutation.
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Program Overview
The purpose of this study is to see if a new combination of drugs—Sotorasib, Panitumumab, and FOLFIRI—can help patients with metastatic colorectal cancer live longer without their disease getting worse. The study will compare this new treatment to the standard treatment, FOLFIRI, with or without another drug called Bevacizumab-awwb. This study is for patients who have not received any previous treatment for their cancer and have a specific mutation in the KRAS gene known as p.G12C.
Eligibility Criteria
Inclusion Criteria
- Have metastatic colorectal cancer confirmed by lab tests, with a specific KRAS p.G12C mutation.
- Have measurable cancer that can be tracked using standard criteria.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ function as determined by specific medical tests.
Exclusion Criteria
- Have active or untreated cancer that has spread to the brain.
- Have cancer that has spread to the membranes surrounding the brain and spinal cord (leptomeningeal disease).
- Have previously been treated with a KRAS p.G12C inhibitor.
- Have a history of lung diseases like interstitial pneumonitis or pulmonary fibrosis, or show signs of these conditions on a CT scan.
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