Comparing new treatments for metastatic colorectal cancer with a specific mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ironwood Cancer and Research Centers Scottsdale
  Chandler, Arizona, United States Recruiting
• City of Hope National Medical Center
  Long Beach, California, United States Recruiting
• Cancer and Blood Research Center, LLC
  Los Alamitos, California, United States Recruiting
• Cancer Specialists of North Florida - Southpoint
  Jacksonville, Florida, United States Recruiting
• Insight Research Institute
  Chicago, Illinois, United States Recruiting
• Pikeville Medical Center
  Pikeville, Kentucky, United States Recruiting

+241 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.