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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Aug 2026

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At a glance

  • Drugs Panitumumab (Primary) ; Sotorasib (Primary) ; Regorafenib; Tipiracil/trifluridine
  • Indications Adenocarcinoma; Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms CodeBreak300
  • Sponsors Amgen

Most Recent Events

  • 27 Apr 2026 Status changed from active, no longer recruiting to completed.
  • 06 Feb 2026 Planned End Date changed from 31 Jan 2026 to 14 May 2026.
  • 30 Apr 2025 Results (n=140) assessing the baseline genetic co-occurring alterations and their impact on the efficacy of sotorasib plus panitumumab in this study, presented at the 116th Annual Meeting of the American Association for Cancer Research.

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