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

ClinicalTrials ID:NCT06252649

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

Locations

FACILITYZIPCITYSTATE
Ironwood Cancer and Research Centers Scottsdale85224ChandlerArizona
Providence Saint Jude Medical Center92835FullertonCalifornia
Cancer and Blood Specialty Clinic90720Los AlamitosCalifornia
Norwalk Hospital06856NorwalkConnecticut
Cancer Specialists of North Florida32256JacksonvilleFlorida
D and H Cancer Research Center33063MargateFlorida
Mid Florida Hematology and Oncology Centers PA32763Orange CityFlorida
Boca Raton Clinical Research Medical Center Inc33322PlantationFlorida
Georgia Cancer Specialists30342AtlantaGeorgia
Hope and Healing Cancer Services60521HinsdaleIllinois

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