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
A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy
- Colorectal Neoplasms
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 700
- Started
- 12 December 2024
- Main results due
- 15 December 2027
- Study sites
- 251
- 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 colon or rectum. Participants must have recurrent, unresectable or metastatic disease * Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing * Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible * Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 * Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1 * Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy 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: amivantamab, cetuximab or bevacizumab or 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 who has not received immunotherapy treatments * Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor * Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)
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) 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.
Study sites(251)
Ironwood Cancer and Research Center
Chandler, Arizona, United States
Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Recruiting
Arizona Oncology Associates PC NAHOA
Prescott, Arizona, United States
Completed
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
University of Colorado Denver Anschultz Medical Campus
Aurora, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Recruiting
Eastern Connecticut Hematology & Oncology Assoc.
Norwich, Connecticut, United States
Completed
Florida Cancer Specialists South
Fort Myers, Florida, United States
Recruiting
Mount Sinai Medical Center Campus
Miami Beach, Florida, United States
Completed
AdventHealth Cancer Institute
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
University Cancer And Blood Center LLC
Athens, Georgia, United States
Recruiting
Grady Memorial Hospital
Atlanta, Georgia, United States
Recruiting
Piedmont Cancer Institute
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
Franciscan Health
Indianapolis, Indiana, United States
Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Recruiting
Mission Cancer Blood
Waukee, Iowa, United States
Recruiting
Cancer Center of Kansas
Wichita, Kansas, United States
Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, 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
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Recruiting
Henry Ford Hospital
Detroit, Michigan, United States
Recruiting
Cancer And Hematology Centers of Western Michigan PC
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
Omaha, Nebraska, United States
Recruiting
Astera Cancer Care
East Brunswick, New Jersey, United States
Recruiting
Perlmutter Cancer Center at NYU Long Island
Mineola, New York, United States
Recruiting
NYU Langone Medical Center NYU Hematology Associates
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
Gabrail Cancer Center
Canton, Ohio, United States
Recruiting
University Hospital of Cleveland
Cleveland, Ohio, United States
Recruiting
Oregon Health And Science University
Portland, Oregon, United States
Recruiting
Alliance Cancer Specialists at Main Line
Penn Wynne, Pennsylvania, United States
Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Recruiting
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Recruiting
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Recruiting
SCRI Oncology Partners
Nashville, Tennessee, United States
Recruiting
Tennessee Oncology
Nashville, Tennessee, United States
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Recruiting
Texas Oncology West Texas
Abilene, Texas, United States
Recruiting
Parkland Health and Hospital System
Dallas, Texas, United States
Recruiting
Texas Oncology DFW
Dallas, Texas, United States
Recruiting
UT Southwestern Medical Center
Dallas, Texas, United States
Recruiting
Showing 60 of 251 sites — filter to narrow it down. 237 of the 251 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 NCT06750094. 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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