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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

RecruitingPhase 3Ages 18 Years - anyAllAmgen
NCT06252649 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • FOLFIRI Regimen
  • Sotorasib
  • Panitumumab
  • Bevacizumab-awwb
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Where

291 sites
Ironwood Cancer and Research Centers Scottsdale
Chandler, United States
Providence Saint Jude Medical Center
Fullerton, United States
City of Hope National Medical Center
Long Beach, United States
Cancer and Blood Research Center, LLC
Los Alamitos, United States
California Research Institute
Los Angeles, United States
Norwalk Hospital
Norwalk, United States
Cancer Specialists of North Florida - Southpoint
Jacksonville, United States
D and H Cancer Research Center
Margate, United States

…and 283 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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