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A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy

Protocol No
MIRATI-849-010-KRYSTAL-10
Principal Investigator
Ben George
Phase
III
Summary
This study will compare the effectiveness of MRTX849 in combination with Cetuximab (investigational arm) versus standard of care second-line treatment consisting of either FOLFIRI or mFOLFOX6 chemotherapy (comparator arm) in patients with advanced colorectal cancer who have a specific change in tumor genes (KRAS G12C) and who are experiencing progression on or after first-line chemotherapy. Chemotherapy is a treatment that includes a medication or combination of medications that work throughout the body to help fight cancer. Other objectives of the study include evaluating the safety of MRTX849 in combination with Cetuximab, assessing how quickly MRTX849 is absorbed into the blood stream and how fast it is removed, and evaluating your health-related quality of life. Several laboratory tests will be performed using samples of tumor tissue or blood to understand how and why MRTX849 with Cetuximab may work in the treatment of colorectal cancer.
Description
Phase 3 Study of MRTX849 with Cetuximab vs Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation (KRYSTAL-10)
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL