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