drugset / Trial / 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

NCT06252649

Phase 3 Recruiting 450 enrolled Amgen
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-07-17
Primary completion
2028-09-25
Completion
2032-04-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody Intravenous
Subject Panitumumab Monoclonal antibody Intravenous
Subject Sotorasib Small molecule Oral
Background Irinotecan Small molecule Intravenous
Background Leucovorin Small molecule Intravenous
Background fluorouracil Small molecule Intravenous

Indications