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

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) 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.

Key facts

Study ID

NCT06750094

Run by

Janssen Research & Development, LLC

People needed

700

Starts

2024-12-12

Expected to finish

2029-04-13

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 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

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: 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)

Where it is running

• Illinois CancerCare — Peoria, Illinois, United States (enrolling)
• Franciscan Health — Indianapolis, Indiana, United States (enrolling)
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
• Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
• CBCC Global Research — Bakersfield, California, United States (enrolling)
• Ironwood Cancer and Research Center — Chandler, Arizona, United States (enrolling)
• St. Bernard's Medical Center — Jonesboro, Arkansas, 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)
• University of Colorado Denver Anschultz Medical Campus — Aurora, Colorado, United States (enrolling)
• Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
• Los Angeles Cancer Network — Glendale, California, United States (enrolling)
• Florida Cancer Specialists South — Fort Myers, Florida, United States (enrolling)
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (enrolling)
• AdventHealth Cancer Institute — 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)
• University Cancer And Blood Center LLC — Athens, Georgia, United States (enrolling)
• Grady Memorial Hospital — Atlanta, Georgia, United States (enrolling)
• Piedmont Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Winship Cancer Institute Emory University — Atlanta, Georgia, United States (enrolling)
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States (enrolling)
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (enrolling)

Full record on ClinicalTrials.gov

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