Clinical Trial

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Study acronym: OrigAMI-2
Recruiting Phase 3
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Summary
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.
Protocol Amendment History 1 change
notable Trial sites expanded: 231 -> 234 locations 2026-04-14
Trial Details
NCT Number NCT06662786
Lead Sponsor Janssen Research & Development, LLC
Conditions Colorectal Neoplasms
Enrollment 1,000 participants
Start Date 2024-10-18
Primary Completion 2028-12-15 (estimated)
Study Completion 2032-01-20 (estimated)
Updated on ClinicalTrials.gov 2026-07-06