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

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06252649

Patient View

This clinical trial evaluates progression-free survival in treatment-naïve mCRC patients with KRAS p.G12C mutation. Eligible participants must have confirmed KRAS p.G12C mutation, measurable metastatic disease, ECOG ≤ 1, and adequate organ function. Interventions include FOLFIRI, sotorasib, panitumumab, and optional bevacizumab-awwb, administered via specified regimens.

Patient Parameters

Program Overview

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.

Eligibility Criteria

Inclusion Criteria

  • Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
  • Central confirmation 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

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