Comparing Sotorasib Plus Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Adults with KRAS p.G12C Mutated Metastatic Colorectal Cancer

What this Trial Is About

This research aims to compare progression-free survival in adults with metastatic colorectal cancer harboring the KRAS p.G12C mutation who have not yet received treatment. The study evaluates the effectiveness of combining sotorasib, panitumumab, and FOLFIRI chemotherapy versus FOLFIRI chemotherapy with or without bevacizumab-awwb. This comparison is important for understanding treatment options for this specific cancer mutation. Participants will be randomly assigned to one of two treatment groups. One group will take sotorasib orally every day along with panitumumab and FOLFIRI given by intravenous infusion every two weeks. The other group will receive FOLFIRI chemotherapy every two weeks, with or without bevacizumab-awwb infusion. Treatments will continue as per study protocol to assess their impact on cancer progression. During the study, participants will have their disease monitored using imaging tests based on RECIST v1.1 criteria for up to about three years to measure progression-free survival. Additional outcomes such as overall survival, response rates, duration of response, and adverse events will be tracked for up to five years. The study includes regular medical assessments, laboratory tests, and safety monitoring throughout the treatment and follow-up periods.

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