Trial Profile

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)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 19 Jun 2026

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At a glance

Drugs Fluorouracil (Primary) ; Folinic acid (Primary) ; Irinotecan (Primary) ; Panitumumab (Primary) ; Sotorasib (Primary) ; Bevacizumab
Indications Adenocarcinoma; Colorectal cancer
Focus Registrational; Therapeutic Use
Acronyms CodeBreaK 301
Sponsors Amgen

10 Jun 2026 Planned End Date changed from 31 Aug 2031 to 25 Apr 2032.
10 Jun 2026 Planned primary completion date changed from 31 Jan 2028 to 25 Sep 2028.
06 Feb 2025 Planned End Date changed from 30 Apr 2031 to 31 Aug 2031.

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