Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-nave Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-nave Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
The aim of this study is to compare progression free survival (PFS) in treatment-nave participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.
Not Available
Phase III
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
ABX-EGF,
Bevacizumab,
Fluorouracil (5-FU),
Irinotecan,
Leucovorin,
Panitumumab,
Sotorasib
Eng, Cathy
International
Vanderbilt University
09-11-2025
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
Central laboratory detection of KRAS p.G12C mutation.
Central laboratory detection of KRAS p.G12C mutation.
Measurable metastatic disease per RECIST v1.1 criteria.
Measurable metastatic disease per RECIST v1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
Adequate organ function.
Adequate organ function.
Exclusion Criteria:
Active, untreated brain metastases.
Active, untreated brain metastases.
Leptomeningeal disease
Leptomeningeal disease
Previous treatment with a KRAS p.G12C inhibitor
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
History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan
Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
Central laboratory detection of KRAS p.G12C mutation.
Central laboratory detection of KRAS p.G12C mutation.
Measurable metastatic disease per RECIST v1.1 criteria.
Measurable metastatic disease per RECIST v1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
Adequate organ function.
Adequate organ function.
Exclusion Criteria:
Active, untreated brain metastases.
Active, untreated brain metastases.
Leptomeningeal disease
Leptomeningeal disease
Previous treatment with a KRAS p.G12C inhibitor
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
History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan
