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Comparing new treatments for metastatic colorectal cancer with a specific mutation

Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

Phase 3 Interventional Amgen · NCT06252649

This study is testing if a new combination of treatments can help people with a specific type of metastatic colorectal cancer feel better compared to standard treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionspanitumumab, bevacizumab
Locations286 sites (Chandler, Arizona and 285 other locations)
Trial IDNCT06252649 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a combination of sotorasib, panitumumab, and FOLFIRI compared to FOLFIRI with or without bevacizumab-awwb in patients with treatment-naïve metastatic colorectal cancer harboring the KRAS p.G12C mutation. Participants will be monitored for progression-free survival (PFS) to determine which treatment regimen offers better outcomes. The study will include patients with measurable metastatic disease and adequate organ function, while excluding those with certain complications or previous treatments that may interfere with the results.

Who should consider this trial

Good fit: Ideal candidates are individuals with pathologically confirmed metastatic colorectal adenocarcinoma and a KRAS p.G12C mutation who have not received prior treatment.

Not a fit: Patients with active brain metastases, leptomeningeal disease, or a history of certain pulmonary conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with KRAS p.G12C mutated metastatic colorectal cancer.

How similar studies have performed: Other studies have shown promise in targeting KRAS mutations, making this approach potentially beneficial but still requiring further validation.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Chandler, Arizona and 285 other locations

+236 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Colorectal CancerSotorasibPanitumumabFOLFIRIBevacizumab-awwbOncology
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.