The Phase 3 study (NCT05198934) investigating sotorasib in combination with panitumumab for participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) completed its primary phase on 2025-07-16. This trial compared the combination therapy against investigator's choice of trifluridine and tipiracil or regorafenib.
Background
The study focuses on colorectal cancer (CRC) with a specific Kirsten rat sarcoma (KRAS) p.G12C mutation. Sotorasib is being investigated in combination with panitumumab for this patient population.
Trial design
The study, identified as NCT05198934, is a Phase 3 trial that enrolled 160 participants. The trial investigated treatment for participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) who had been previously treated. The study's aim was to compare progression-free survival (PFS) in participants receiving sotorasib 240 mg once daily (QD) and panitumumab versus investigator's choice (either trifluridine and tipiracil or regorafenib). Another arm compared sotorasib 960 mg QD and panitumumab versus investigator's choice.
What this means
The completion of the primary phase for this Phase 3 trial indicates that data collection for the main outcomes has concluded. The results, once analyzed and released, will provide important information regarding the efficacy of sotorasib in combination with panitumumab for patients with KRAS p.G12C mutated colorectal cancer, compared to standard investigator's choice treatments.
Source
Information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT05198934, titled "Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation," was posted on 2025-07-16 on clinicaltrials.gov.