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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

NCT06750094 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms

Interventions

BIOLOGICAL

Amivantamab

Amivantamab will be administered.

BIOLOGICAL

Cetuximab

Cetuximab will be administered.

BIOLOGICAL

Bevacizumab

Bevacizumab 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

Irinotecan

Irinotecan will be administered as chemotherapy regimen.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2027-12-15
Completion
2029-04-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • China
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico
  • Romania
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750094 on ClinicalTrials.gov