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
Purpose
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.
Condition
- Metastatic Colorectal Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: Sotorasib + Panitumumab + FOLFIRI |
Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion. |
|
|
Active Comparator Arm B: FOLFIRI with or Without Bevacizumab-awwb |
Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb. |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
Nashville 4644585, Tennessee 4662168 37232
More Details
- Status
- Recruiting
- Sponsor
- Amgen