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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
StatusRecruiting
PhasePhase 3
Started2024-12-12
View on ClinicalTrials.gov ↗
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.

Amendment history 4 changes detected by DataLookout

2026-07-07
Trial sites expanded: 247 → 250 locations
2026-06-06
Trial sites expanded: 241 → 247 locations
2026-05-09
Trial sites expanded: 234 → 241 locations
2026-04-14
Trial sites expanded: 229 → 234 locations
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 2026-08-28