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

Recruiting now · Phase 3

Conditions studied: Colorectal Neoplasms

In brief

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.

Key facts

Study ID

NCT06662786

Run by

Janssen Research & Development, LLC

People needed

1000

Starts

2024-10-18

Expected to finish

2032-01-20

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• St. Bernard's Medical Center — Jonesboro, Arkansas, United States (enrolling)
• Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
• CBCC Global Research — Bakersfield, California, United States (enrolling)
• Los Angeles Cancer Network — Glendale, California, United States (enrolling)
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (enrolling)
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• UCLA — Santa Monica, California, United States (enrolling)
• Providence Medical Foundation — Santa Rosa, California, United States (enrolling)
• Torrance Memorial Physicians Network — Torrance, California, United States (enrolling)
• Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
• Yale University School Of Medicine — New Haven, Connecticut, United States (enrolling)
• Georgetown Univ Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia, United States (enrolling)
• Florida Cancer Specialists South — Fort Myers, Florida, United States (enrolling)
• AdventHealth Medical Group Oncology and Hematology at Orlando — Orlando, Florida, United States (enrolling)
• Florida Cancer Specialists North Region — St. Petersburg, Florida, United States (enrolling)
• Florida Cancer Specialists East — West Palm Beach, Florida, United States (enrolling)
• Grady Memorial Hospital — Atlanta, Georgia, United States (enrolling)
• Winship Cancer Institute Emory University — Atlanta, Georgia, United States (enrolling)
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States (enrolling)
• Illinois CancerCare — Peoria, Illinois, United States (enrolling)
• Fort Wayne Medical Oncology & Hematology — Fort Wayne, Indiana, United States (enrolling)
• University of Iowa Hospital — Iowa City, Iowa, United States (enrolling)
• Mission Cancer Blood — Waukee, Iowa, United States (enrolling)
• Cancer Center of Kansas — Wichita, Kansas, United States (enrolling)
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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