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
Sponsor: Amgen
Sponsor score: 60
ClinicalTrials ID:NCT06252649
This clinical trial evaluates progression-free survival in treatment-naïve mCRC patients with KRAS p.G12C mutation. Eligible participants must have confirmed KRAS p.G12C mutation, measurable metastatic disease, ECOG ≤ 1, and adequate organ function. Interventions include FOLFIRI, sotorasib, panitumumab, and optional bevacizumab-awwb, administered via specified regimens.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
Eligibility Criteria
Inclusion Criteria
- Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
- Central confirmation 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ironwood Cancer and Research Centers Scottsdale | 85224 | Chandler | Arizona |
| Providence Saint Jude Medical Center | 92835 | Fullerton | California |
| Cancer and Blood Specialty Clinic | 90720 | Los Alamitos | California |
| Norwalk Hospital | 06856 | Norwalk | Connecticut |
| Cancer Specialists of North Florida | 32256 | Jacksonville | Florida |
| D and H Cancer Research Center | 33063 | Margate | Florida |
| Mid Florida Hematology and Oncology Centers PA | 32763 | Orange City | Florida |
| Boca Raton Clinical Research Medical Center Inc | 33322 | Plantation | Florida |
| Georgia Cancer Specialists | 30342 | Atlanta | Georgia |
| Hope and Healing Cancer Services | 60521 | Hinsdale | Illinois |
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