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Comparing Amivantamab with FOLFIRI to Cetuximab/Bevacizumab with FOLFIRI for Colorectal Cancer

A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy

Phase 3 Interventional Janssen Research & Development, LLC · NCT06750094

This study is testing if a new treatment combining amivantamab with FOLFIRI can help people with certain types of colorectal cancer live longer and feel better compared to the standard treatment with cetuximab or bevacizumab plus FOLFIRI.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsamivantamab, cetuximab, bevacizumab, immunotherapy, chemotherapy
Locations241 sites (Chandler, Arizona and 240 other locations)
Trial IDNCT06750094 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of amivantamab combined with FOLFIRI chemotherapy against the combination of cetuximab or bevacizumab with FOLFIRI in patients with KRAS, NRAS, and BRAF wild-type colorectal cancer who have previously undergone chemotherapy. The primary focus is on measuring progression-free survival and overall survival among participants with recurrent, unresectable, or metastatic disease. Participants must have measurable disease and a performance status of 0 or 1, and they will be required to provide tumor tissue samples post-progression if feasible.

Who should consider this trial

Good fit: Ideal candidates are adults with KRAS, NRAS, and BRAF wild-type colorectal cancer who have previously received chemotherapy and have measurable disease.

Not a fit: Patients with a history of interstitial lung disease or those currently experiencing pulmonary complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option that improves survival rates for patients with advanced colorectal cancer.

How similar studies have performed: Other studies have shown promise with similar treatment approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

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: 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 this trial is running

Chandler, Arizona and 240 other locations

+191 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colorectal Neoplasms
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.