NCT06662786

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

A Randomized, Open-label Phase 3 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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Amivantamab	Amivantamab will be administered.
BIOLOGICAL	Cetuximab	Cetuximab will be administered.
DRUG	5-fluorouracil	5-fluorouracil will be administered as chemotherapy regimen.
DRUG	Leucovorin calcium/Levoleucovorin	Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
DRUG	Oxaliplatin	Oxaliplatin will be administered as chemotherapy regimen.
DRUG	Irinotecan Hydrochloride	Irinotecan hydrochloride will be administered as chemotherapy regimen.

Timeline

• Start date: 2024-10-18
• Primary completion: 2028-12-15
• Completion: 2032-01-30
• First posted: 2024-10-29
• Last updated: 2026-04-13

Locations

234 sites across 22 countries: United States, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study