Title: A phase 3 multicenter, randomized, open-label, active-controlled study of sotorasib and panitumumab versus investigator’s choice (trifluridine and tipiracil, or regorafenib) for the treatment of previously treated metastatic colorectal cancer subjects with kirsten rat sarcoma (KRAS) p.G12C mutation

Responsible Party: Amgen

Description: Researchers are conducting a phase 3 trial to compare sotorasib plus panitumumab with investigator’s choice of therapy in patients with previously treated, KRAS p.G12C-mutated metastatic colorectal cancer.

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The researchers are testing 2 doses of sotorasib. In arm A, patients will receive 960 mg of sotorasib orally once daily, plus a standard dosing regimen of intravenous panitumumab. In arm B, patients will receive 240 mg of sotorasib and a standard dosing regimen of panitumumab.

In arm C, patients will receive investigator’s choice of oral therapy, which consists of regoragenfib alone or trifluridine and tipiracil in combination. 

The trial’s primary endpoint is progression-free survival. Secondary endpoints include overall survival, objective response rate, duration of response, treatment-emergent adverse events, and other outcomes.

To be eligible for this trial, patients must be 18 years of age or older. They must have a pathologically confirmed diagnosis of KRAS p.G12C-mutated metastatic colorectal cancer, and they must have received at least 1 prior line of therapy for metastatic disease. For a complete list of eligibility criteria, please see the reference.

Status: Recruiting

This trial is sponsored by Amgen.


ClinicalTrials.gov. Sotorasib and panitumumab versus investigator’s choice for participants with kirsten rat sarcoma (KRAS) p.G12C mutation (CodeBreak 300). NCT05198934. Accessed March 23, 2023.