Recruiting NCT06252649

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

Colorectal CancerPhase 3Stage IIIStage IVKRAS

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

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.