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 Genders
- All
- Accepts Healthy Volunteers
- No
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
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 was taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI were received every 2 weeks (Q2W) via intravenous infusion (IV). |
|
|
Active Comparator Arm B: FOLFIRI with or Without Bevacizumab-awwb |
Participants received FOLFIRI Q2W with or without bevacizumab-awwb. |
|
Recruiting Locations
Ironwood Cancer and Research Centers Scottsdale
Chandler, Arizona 85224
Chandler, Arizona 85224
Providence Saint Jude Medical Center
Fullerton, California 92835
Fullerton, California 92835
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
Los Alamitos, California 90720
California Research Institute
Los Angeles, California 90027
Los Angeles, California 90027
Norwalk Hospital
Norwalk, Connecticut 06856
Norwalk, Connecticut 06856
Cancer Specialists of North Florida
Jacksonville, Florida 32256
Jacksonville, Florida 32256
D and H Cancer Research Center
Margate, Florida 33063
Margate, Florida 33063
Mid Florida Hematology and Oncology Centers PA
Orange City, Florida 32763
Orange City, Florida 32763
Boca Raton Clinical Research Medical Center Inc
Plantation, Florida 33322
Plantation, Florida 33322
Georgia Cancer Specialists
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Hope and Healing Cancer Services
Hinsdale, Illinois 60521
Hinsdale, Illinois 60521
Orchard Healthcare Research Inc
Skokie, Illinois 60076
Skokie, Illinois 60076
Pikeville Medical Center
Pikeville, Kentucky 41501
Pikeville, Kentucky 41501
Henry Ford Health System
Detroit, Michigan 48202
Detroit, Michigan 48202
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Saint Louis Cancer Care West County
Bridgeton, Missouri 63044
Bridgeton, Missouri 63044
Minniti Center for Medical Oncology and Hematology
Mickleton, New Jersey 08056
Mickleton, New Jersey 08056
Duke Cancer Center
Durham, North Carolina 27710
Durham, North Carolina 27710
FirstHealth Cancer Center
Pinehurst, North Carolina 28374
Pinehurst, North Carolina 28374
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Tennessee Oncology PLLC - Chattanooga
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Tennessee Oncology PLLC
Nashville, Tennessee 37203
Nashville, Tennessee 37203
More Details
- NCT ID
- NCT06252649
- Status
- Recruiting
- Sponsor
- Amgen