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RecruitingPhase 3NCT06252649

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

This trial is for people with newly diagnosed metastatic colorectal cancer carrying a KRAS G12C mutation. It tests whether adding sotorasib and panitumumab to FOLFIRI chemotherapy works better than FOLFIRI with or without bevacizumab.

SponsorAmgen
Study typeInterventional
Started2024-07-17
Primary completion2028-09-25
Planned enrolment450
Sites1 Acıbadem · 290 other

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)

What this study is about

The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

Conditions
  • Metastatic Colorectal Cancer
Interventions
  • FOLFIRI Regimen
  • Sotorasib
  • Panitumumab
  • Bevacizumab-awwb
Primary outcome measures
  • PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) — Up to Approximately 3 Years
Who can take part
SexAllAge18 Years to no upper limitHealthy volunteersNo
Inclusion
* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay. * Central laboratory detection of KRAS p.G12C mutation. * Measurable metastatic disease per RECIST v1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. * Adequate organ function.
Exclusion
* Active, untreated brain metastases. * Leptomeningeal disease * Previous treatment with a KRAS p.G12C inhibitor * History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

Acıbadem study sites
  • Acıbadem Altunizade Hastanesi, IstanbulTerminated

Also running at 290 other sites in 35 countries.

Source: ClinicalTrials.gov NCT06252649 · last updated 2026-09-03 · View registry record ↗

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