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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

NCT06252649

RecruitingPhase 3

Sponsor: Amgen

Conditions: Metastatic Colorectal Cancer

Interventions: FOLFIRI Regimen, Sotorasib, Panitumumab, Bevacizumab-awwb

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (291)

Chandler, Arizona, United States
Fullerton, California, United States
Long Beach, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Norwalk, Connecticut, United States
Jacksonville, Florida, United States
Margate, Florida, United States
Orange City, Florida, United States
Plantation, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Hinsdale, Illinois, United States
Skokie, Illinois, United States
Pikeville, Kentucky, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Bridgeton, Missouri, United States
Mickleton, New Jersey, United States
Durham, North Carolina, United States
Pinehurst, North Carolina, United States
Philadelphia, Pennsylvania, United States
Rock Hill, South Carolina, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
CABA, Buenos Aires, Argentina
CABA, Buenos Aires, Argentina
CABA, Buenos Aires, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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