Home › Colorectal Cancer › 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
RecruitingPhase 3
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
Who can join
Ages 18 and older · All sexes
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)
About the study
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.
What is being tested
- Amivantamab (biological)
- Cetuximab (biological)
- 5-fluorouracil (drug)
- Leucovorin calcium/Levoleucovorin (drug)
- Oxaliplatin (drug)
- Irinotecan Hydrochloride (drug)
Sponsor: Janssen Research & Development, LLC · Participants: 1,000 · Started: Oct 18, 2024
Contact the study team
Official record on ClinicalTrials.gov — NCT06662786
Locations in the U.S.
| Arizona | Banner MD Anderson Cancer Center, Gilbert |
| Arkansas | St. Bernard's Medical Center, Jonesboro Highlands Oncology Group, Springdale |
| California | CBCC Global Research, Bakersfield Los Angeles Cancer Network, Glendale Cancer and Blood Specialty Clinic, Los Alamitos USC Norris Comprehensive Cancer Center, Los Angeles UCLA, Santa Monica Providence Medical Foundation, Santa Rosa Torrance Memorial Physicians Network, Torrance |
| Colorado | Rocky Mountain Cancer Centers, Denver |
| Connecticut | Yale University School Of Medicine, New Haven |
| District of Columbia | Georgetown Univ Medical Center Lombardi Cancer Center, Washington D.C. |
| Florida | Florida Cancer Specialists South, Fort Myers AdventHealth Medical Group Oncology and Hematology at Orlando, Orlando Florida Cancer Specialists North Region, St. Petersburg Florida Cancer Specialists East, West Palm Beach |
| Georgia | Grady Memorial Hospital, Atlanta Winship Cancer Institute Emory University, Atlanta |
| Illinois | Illinois Cancer Specialists, Arlington Heights Illinois CancerCare, Peoria |
| Indiana | Fort Wayne Medical Oncology & Hematology, Fort Wayne |
| Iowa | University of Iowa Hospital, Iowa City Mission Cancer Blood, Waukee |
| Kansas | Cancer Center of Kansas, Wichita |
| Louisiana | Ochsner Clinic Foundation, New Orleans |
| Maryland | MedStar Franklin Square Medical Center, Baltimore Frederick Health Hospital - James M Stockman Cancer Institute, Frederick |
| Michigan | University of Michigan, Ann Arbor VA Ann Arbor Healthcare System, Ann Arbor Henry Ford Hospital, Detroit Start Midwest, Grand Rapids |
| Mississippi | Hattiesburg Clinic, Hattiesburg |
| Missouri | Washington University School Of Medicine, St Louis |
| Nebraska | Nebraska Cancer Specialists Midwest Cancer Center, Omaha |
| Nevada | Comprehensive Cancer Centers of Nevada, Las Vegas |
| New Jersey | Astera Cancer Care, East Brunswick Rutgers Cancer Institute, New Brunswick |
| New Mexico | University of New Mexico Cancer Center, Albuquerque |
| New York | Perlmutter Cancer Center at NYU Long Island, Mineola Herbert Irving Comprehensive Cancer Center Columbia University Medical Center, New York Mount Sinai, New York Mount Sinai West, New York NYU Langone Medical Center NYU Hematology Associates, New York New York Cancer and Blood Specialists, Shirley Montefiore Einstein Comprehensive Cancer Center, The Bronx University of Buffalo Kaleida Health Cancer Care, Williamsville |
| North Carolina | University of North Carolina at Chapel Hill, Chapel Hill |
| Ohio | Gabrail Cancer Center, Canton Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion, Cleveland Taussig Cancer Insititute Cleveland Clinic, Cleveland University Hospitals Cleveland Medical Center, Cleveland Cleveland Clinic Cancer Center Independence Family Health Center, Independence Cleveland Clinic Cancer Center Mansfield, Mansfield Cleveland Clinic Cancer Center Hillcrest Hospital, Mayfield Heights Cleveland Clinic Cancer Centers Sandusky, Sandusky Cleveland Clinic Cancer Center Strongsville, Strongsville Cleveland Clinic Cancer Center South Pointe Hospital, Warrensville Heights Wooster Milltown Specialty and Surgery Center, Wooster |
| Oregon | St Charles Medical Center, Bend Oregon Health And Science University, Portland |
| Pennsylvania | Fox Chase Cancer Center, Philadelphia Thomas Jefferson University, Philadelphia University Of Pittsburgh Medical Center UPMC Hillman Cancer Center, Pittsburgh |
| Tennessee | SCRI Oncology Partners, Nashville |
| Texas | Texas Oncology West Texas, Abilene Texas Oncology DFW, Dallas UT Southwestern, Dallas MD Anderson Cancer Center, Houston Baylor Scott and White Health 1, Round Rock Texas Oncology - San Antonio, San Antonio Baylor Scott and White Health, Temple |
| Virginia | Virginia Cancer Specialists, Arlington Inova Schar Cancer Institute Dept of Fairfax Hospital, Fairfax Richmond VA Medical Center, Richmond VCU Massey Comprehensive Cancer Center, Richmond |
| Washington | Swedish Cancer Institute Edmonds, Edmonds Swedish Cancer Institute Issaquah, Issaquah Fred Hutchinson Cancer Research Center, Seattle Swedish Cancer Institute, Seattle |
| Wisconsin | William S. Middleton Memorial VA, Madison |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.