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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmgen

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • FOLFIRI Regimen
  • Sotorasib
  • Panitumumab
  • Bevacizumab-awwb

Treatment groups

450 Participants
are divided into 2 treatment groups

Sponsors and collaborators