Clinical Trial

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

Study acronym: OrigAMI-3
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
Protocol Amendment History 4 changes
notable Trial sites expanded: 247 -> 250 locations 2026-07-07
notable Trial sites expanded: 241 -> 247 locations 2026-06-06
notable Trial sites expanded: 234 -> 241 locations 2026-05-09
notable Trial sites expanded: 229 -> 234 locations 2026-04-14
Trial Details
NCT Number NCT06750094
Lead Sponsor Janssen Research & Development, LLC
Conditions Colorectal Neoplasms
Enrollment 700 participants
Start Date 2024-12-12
Primary Completion 2027-12-15 (estimated)
Study Completion 2029-04-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-06