Actively Recruiting
A Randomized, Open-label Phase 3 Study of Amivantamab FOLFIRI Versus Cetuximab or Bevacizumab FOLFIRI in Participants With KRASNRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
700
Participants Needed
247
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for participants with KRASNRAS and BRAF wild-type colorectal cancer that is recurrent, unresectable, or metastatic. The study compares the length of time participants remain disease-free and overall survival when treated with amivantamab plus chemotherapy versus cetuximab or bevacizumab plus chemotherapy. All participants have previously received chemotherapy, and the study is a randomized, open-label phase 3 trial sponsored by Janssen Research Development, LLC. Participants are assigned to one of two groups. One group receives amivantamab combined with the FOLFIRI chemotherapy regimen, which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan. The other group receives either cetuximab or bevacizumab combined with FOLFIRI. Treatments are given in 28-day cycles and continue until the disease progresses or other reasons require stopping treatment. During the study, participants undergo regular assessments including imaging to monitor disease status and response to treatment. Researchers measure progression-free survival, overall survival, response rates, duration of response, and quality of life through questionnaires. Safety is monitored by tracking adverse events and laboratory test changes. The primary outcomes are evaluated up to about 2 years for progression-free survival and over 4 years for overall survival, with several secondary outcomes assessed up to the same longer timeframe.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum with recurrent, unresectable or metastatic disease
- Have KRAS/NRAS G12, G13 and BRAF V600X wild-type status confirmed by local or central next-generation sequencing
- Agree to submit fresh or archival tumor tissue post progression from the most recent therapy if feasible
- Have measurable disease according to RECIST version 1.1
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have received one line of systemic fluoropyrimidine-based and oxaliplatin-based therapy for metastatic colorectal cancer with documented disease progression
- May have received prior anti-VEGF therapy
You will not qualify if you...
- History or current diagnosis of noninfectious interstitial lung disease, pneumonitis, or pulmonary fibrosis, or suspected ILD/pneumonitis/pulmonary fibrosis not ruled out by imaging
- Known allergies, hypersensitivity, or intolerance to amivantamab, cetuximab, bevacizumab, or any component of FOLFIRI
- Prior or concurrent second malignancy that may interfere with study endpoints
- Known mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H) status without prior immunotherapy
- Known HER2-positive or amplified tumor
- Prior treatment with irinotecan or agents targeting EGFR or MET
Research Team
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Study Contact
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