NCT06662786From ClinicalTrials.govRecruiting

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

Colorectal Neoplasms

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 1,000
Started: 18 October 2024
Main results due: 15 December 2028
Study sites: 239
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
* Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available)
* Must agree to the submission of fresh tumor tissue
* Have measurable disease according to RECIST v1.1
* Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (\>) 12 months prior to CRC recurrence/metastases
* Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1

Exclusion Criteria:

* Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
* Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI
* Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor
* Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(239)

Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Recruiting
St. Bernard's Medical Center
Jonesboro, Arkansas, United States
Recruiting
Highlands Oncology Group
Springdale, Arkansas, United States
Recruiting
CBCC Global Research
Bakersfield, California, United States
Recruiting
Los Angeles Cancer Network
Glendale, California, United States
Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Recruiting
UCLA
Santa Monica, California, United States
Recruiting
Providence Medical Foundation
Santa Rosa, California, United States
Recruiting
Torrance Memorial Physicians Network
Torrance, California, United States
Recruiting
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Recruiting
Yale University School Of Medicine
New Haven, Connecticut, United States
Recruiting
Georgetown Univ Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Recruiting
Florida Cancer Specialists South
Fort Myers, Florida, United States
Recruiting
AdventHealth Medical Group Oncology and Hematology at Orlando
Orlando, Florida, United States
Recruiting
Florida Cancer Specialists North Region
St. Petersburg, Florida, United States
Recruiting
Florida Cancer Specialists East
West Palm Beach, Florida, United States
Recruiting
Grady Memorial Hospital
Atlanta, Georgia, United States
Recruiting
Winship Cancer Institute Emory University
Atlanta, Georgia, United States
Recruiting
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Recruiting
Illinois CancerCare
Peoria, Illinois, United States
Recruiting
Fort Wayne Medical Oncology & Hematology
Fort Wayne, Indiana, United States
Recruiting
University of Iowa Hospital
Iowa City, Iowa, United States
Recruiting
Mission Cancer Blood
Waukee, Iowa, United States
Recruiting
Cancer Center of Kansas
Wichita, Kansas, United States
Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Recruiting
MedStar Franklin Square Medical Center
Baltimore, Maryland, United States
Recruiting
Frederick Health Hospital - James M Stockman Cancer Institute
Frederick, Maryland, United States
Recruiting
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
Recruiting
University of Michigan
Ann Arbor, Michigan, United States
Recruiting
Henry Ford Hospital
Detroit, Michigan, United States
Recruiting
Start Midwest
Grand Rapids, Michigan, United States
Recruiting
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Recruiting
Washington University School Of Medicine
St Louis, Missouri, United States
Recruiting
Nebraska Cancer Specialists Midwest Cancer Center
Omaha, Nebraska, United States
Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Recruiting
Astera Cancer Care
East Brunswick, New Jersey, United States
Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Recruiting
Perlmutter Cancer Center at NYU Long Island
Mineola, New York, United States
Recruiting
Mount Sinai
New York, New York, United States
Recruiting
Mount Sinai West
New York, New York, United States
Recruiting
NYU Langone Medical Center NYU Hematology Associates
New York, New York, United States
Recruiting
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States
Recruiting
New York Cancer and Blood Specialists
Shirley, New York, United States
Recruiting
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States
Recruiting
University of Buffalo Kaleida Health Cancer Care
Williamsville, New York, United States
Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Recruiting
Gabrail Cancer Center
Canton, Ohio, United States
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Recruiting
Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion
Cleveland, Ohio, United States
Recruiting
Taussig Cancer Insititute Cleveland Clinic
Cleveland, Ohio, United States
Recruiting
Cleveland Clinic Cancer Center Independence Family Health Center
Independence, Ohio, United States
Recruiting
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio, United States
Recruiting
Cleveland Clinic Cancer Center Hillcrest Hospital
Mayfield Heights, Ohio, United States
Recruiting
Cleveland Clinic Cancer Centers Sandusky
Sandusky, Ohio, United States
Recruiting
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, United States
Recruiting
Cleveland Clinic Cancer Center South Pointe Hospital
Warrensville Heights, Ohio, United States
Recruiting
Wooster Milltown Specialty and Surgery Center
Wooster, Ohio, United States
Recruiting
St Charles Medical Center
Bend, Oregon, United States
Recruiting

Showing 60 of 239 sites — filter to narrow it down. 233 of the 239 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06662786. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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