RECRUITINGPhase 3INTERVENTIONAL
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
Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
- your organs (liver, kidneys, etc.) are working well enough based on blood tests.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
FOLFIRI Regimen
Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
DRUG
Sotorasib
Immediate-release solid dosage form administered orally.
DRUG
Panitumumab
Administered via IV infusion Q2W.
DRUG
Bevacizumab-awwb
Administered via IV infusion Q2W.
Locations (20)
Ironwood Cancer and Research Centers Scottsdale
Chandler, Arizona, United States
Providence Saint Jude Medical Center
Fullerton, California, United States
City of Hope National Medical Center
Long Beach, California, United States
Cancer and Blood Research Center, LLC
Los Alamitos, California, United States
California Research Institute
Los Angeles, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida, United States
D and H Cancer Research Center
Margate, Florida, United States
Mid Florida Hematology and Oncology Centers PA
Orange City, Florida, United States
Boca Raton Clinical Research Medical Center Inc
Plantation, Florida, United States
Georgia Cancer Specialists
Atlanta, Georgia, United States
Insight Research Institute
Chicago, Illinois, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Orchard Healthcare Research Inc
Skokie, Illinois, United States
Pikeville Medical Center
Pikeville, Kentucky, United States
Henry Ford Health System
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Saint Louis Cancer Care West County
Bridgeton, Missouri, United States
Minniti Center for Medical Oncology and Hematology
Mickleton, New Jersey, United States
Duke Cancer Center
Durham, North Carolina, United States