Study of Sotorasib, Panitumumab, and FOLFIRI for Metastatic Colorectal Cancer

This study is for people with metastatic colorectal cancer (cancer that has spread) who have a specific change in their cancer called a KRAS p.G12C mutation. You would be new to treatment for your cancer. The study is comparing two different treatment approaches. One group will receive sotorasib, panitumumab, and FOLFIRI (a combination of irinotecan, leucovorin, and 5-fluorouracil). The other group will receive FOLFIRI with or without bevacizumab-awwb. The main goal is to see if one treatment helps you live longer without your cancer growing or spreading (progression-free survival). To join, your cancer must have the KRAS p.G12C mutation, be measurable, and you must be at least 18 years old with good overall health.

Study design
This study plans to enroll 450 participants. It is comparing two different treatment groups to see which is more effective.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long you live without your cancer growing or spreading for up to approximately 3 years.

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NCT06252649

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Amgen
~450 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:FOLFIRI RegimenSotorasibPanitumumabBevacizumab-awwb

At a glance

Recruiting sites
241 of 291 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured over Up to Approximately 3 Years
Metastatic Colorectal Cancer
291 sites across 92 states
Italy19
France16
Turkey (Türkiye)13
Greece11
Germany10
United Kingdom10
Portugal9
Belgium8
  • MD · STUDY_DIRECTOR · Amgen

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Eligibility criteria

Inclusion

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

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
  • PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)Up to Approximately 3 Years