Recruiting

Phase 3

Amivantamab & CetuximabA 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

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06662786

Conditions

Colorectal Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amivantamab

Cetuximab

5-fluorouracil

Leucovorin calcium/Levoleucovorin

Oxaliplatin

Study Details

Brief 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

Study ID

NCT06662786

Start date

Oct 18, 2024

Status verified date

Aug, 2026

Completion date

Jan 20, 2032

Anticipated

Primary completion date

Dec 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Amivantamab in Combination With Chemotherapy

Participants will receive amivantamab in combination with chemotherapy (mFOLFOX6 \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin\] or FOLFIRI \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride\]) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.

active comparator: Arm B: Cetuximab in Combination With Chemotherapy

Participants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.

Interventions

Amivantamab

Amivantamab will be administered.

Cetuximab

Cetuximab will be administered.

5-fluorouracil

5-fluorouracil will be administered as chemotherapy regimen.

Leucovorin calcium/Levoleucovorin

Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.

Oxaliplatin

Oxaliplatin will be administered as chemotherapy regimen.

Irinotecan Hydrochloride

Irinotecan hydrochloride will be administered as chemotherapy regimen.

Primary outcome measure

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to 4 years and 2 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210 Participate-In-This-Study1@its.jnj.com

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

St. Bernard's Medical Center

Recruiting

Jonesboro, Arkansas, United States, 72401

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

CBCC Global Research

Recruiting

Bakersfield, California, United States, 93309

Los Angeles Cancer Network

Recruiting

Glendale, California, United States, 91204

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

UCLA

Recruiting

Santa Monica, California, United States, 90404

Providence Medical Foundation

Recruiting

Santa Rosa, California, United States, 95403

Torrance Memorial Physicians Network

Recruiting

Torrance, California, United States, 90505

Rocky Mountain Cancer Centers

Recruiting

Denver, Colorado, United States, 80218

Yale University School Of Medicine

Recruiting

New Haven, Connecticut, United States, 06519

Georgetown Univ Medical Center Lombardi Cancer Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Florida Cancer Specialists South

Recruiting

Fort Myers, Florida, United States, 33901

AdventHealth Medical Group Oncology and Hematology at Orlando

Recruiting

Orlando, Florida, United States, 32804

Florida Cancer Specialists North Region

Recruiting

St. Petersburg, Florida, United States, 33701-4553

Florida Cancer Specialists East

Recruiting

West Palm Beach, Florida, United States, 33401-3406

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Winship Cancer Institute Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Illinois Cancer Specialists

Recruiting

Arlington Heights, Illinois, United States, 60005

Illinois CancerCare

Recruiting

Peoria, Illinois, United States, 61615

Fort Wayne Medical Oncology & Hematology

Recruiting

Fort Wayne, Indiana, United States, 46804

University of Iowa Hospital

Recruiting

Iowa City, Iowa, United States, 52242

Mission Cancer Blood

Recruiting

Waukee, Iowa, United States, 50263

Cancer Center of Kansas

Recruiting

Wichita, Kansas, United States, 67214

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

MedStar Franklin Square Medical Center

Recruiting

Baltimore, Maryland, United States, 21237

Frederick Health Hospital - James M Stockman Cancer Institute

Recruiting

Frederick, Maryland, United States, 21702-4337

VA Ann Arbor Healthcare System

Recruiting

Ann Arbor, Michigan, United States, 48105

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Start Midwest

Recruiting

Grand Rapids, Michigan, United States, 49503

Hattiesburg Clinic

Recruiting

Hattiesburg, Mississippi, United States, 39401

Washington University School Of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Nebraska Cancer Specialists Midwest Cancer Center

Recruiting

Omaha, Nebraska, United States, 68130

Comprehensive Cancer Centers of Nevada

Recruiting

Las Vegas, Nevada, United States, 89169

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87102

Perlmutter Cancer Center at NYU Long Island

Recruiting

Mineola, New York, United States, 11501

Mount Sinai

Recruiting

New York, New York, United States, 10003

Mount Sinai West

Recruiting

New York, New York, United States, 10009

NYU Langone Medical Center NYU Hematology Associates

Recruiting

New York, New York, United States, 10016

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

Montefiore Einstein Comprehensive Cancer Center

Recruiting

The Bronx, New York, United States, 10461

University of Buffalo Kaleida Health Cancer Care

Recruiting

Williamsville, New York, United States, 14221

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion

Recruiting

Cleveland, Ohio, United States, 44111

Taussig Cancer Insititute Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Cleveland Clinic Cancer Center Independence Family Health Center

Recruiting

Independence, Ohio, United States, 44131

Cleveland Clinic Cancer Center Mansfield

Recruiting

Mansfield, Ohio, United States, 44906

Cleveland Clinic Cancer Center Hillcrest Hospital

Recruiting

Mayfield Heights, Ohio, United States, 44124

Cleveland Clinic Cancer Centers Sandusky

Recruiting

Sandusky, Ohio, United States, 44870

Cleveland Clinic Cancer Center Strongsville

Recruiting

Strongsville, Ohio, United States, 44136

Cleveland Clinic Cancer Center South Pointe Hospital

Recruiting

Warrensville Heights, Ohio, United States, 44122

Wooster Milltown Specialty and Surgery Center

Recruiting

Wooster, Ohio, United States, 44691

St Charles Medical Center

Recruiting

Bend, Oregon, United States, 97701

Oregon Health And Science University

Recruiting

Portland, Oregon, United States, 97239

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232 1301

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology West Texas

Recruiting

Abilene, Texas, United States, 79606

Texas Oncology DFW

Recruiting

Dallas, Texas, United States, 75246

UT Southwestern

Recruiting

Dallas, Texas, United States, 75390

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Baylor Scott and White Health 1

Recruiting

Round Rock, Texas, United States, 78665

Texas Oncology - San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Baylor Scott and White Health

Recruiting

Temple, Texas, United States, 76508

Virginia Cancer Specialists

Recruiting

Arlington, Virginia, United States, 22201

Inova Schar Cancer Institute Dept of Fairfax Hospital

Recruiting

Fairfax, Virginia, United States, 22031

Richmond VA Medical Center

Recruiting

Richmond, Virginia, United States, 23249

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Swedish Cancer Institute Edmonds

Recruiting

Edmonds, Washington, United States, 98026

Swedish Cancer Institute Issaquah

Recruiting

Issaquah, Washington, United States, 98029

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109

William S. Middleton Memorial VA

Recruiting

Madison, Wisconsin, United States, 53705

Arthur J E Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G1X6

Centre de Recherche du CHUM

Recruiting

Montreal, Quebec, Canada, H2X 0C1

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.