Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation

NCT06252649 · CodeBreaK 301 Phase 3Recruiting

Lead sponsor
Amgen (Industry)
Enrollment
450 (estimated)
Start date
17 Jul 2024
Primary completion
25 Sep 2028 (estimated)
Study completion
25 Apr 2032
Last update posted
3 Sep 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
2

Interventions

  • FOLFIRI Regimen Drug
  • Sotorasib Drug
  • Panitumumab Drug
  • Bevacizumab-awwb Drug

Conditions and primary outcome

  • Metastatic Colorectal Cancer

Primary outcome

PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (Up to Approximately 3 Years)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

1 on PubMed
  1. Development of KRAS Inhibitors and Their Role for Metastatic Colorectal Cancer.

    Journal of the National Comprehensive Cancer Network : JNCCN · 2025 Jan 3

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

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Data integrity

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Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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