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Comparing two treatments for advanced left-sided colorectal cancer

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

Phase 3 Interventional Janssen Research & Development, LLC · NCT06662786

This study is testing whether a new drug called amivantamab combined with standard chemotherapy works better than cetuximab with the same chemotherapy for people with advanced left-sided colorectal cancer that can't be surgically removed.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsamivantamab, cetuximab, chemotherapy
Locations235 sites (Gilbert, Arizona and 234 other locations)
Trial IDNCT06662786 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of amivantamab combined with standard chemotherapy (mFOLFOX6 or FOLFIRI) against cetuximab combined with the same chemotherapy in patients with unresectable or metastatic left-sided colorectal cancer. Participants must have tumors that are wild-type for KRAS, NRAS, and BRAF. The primary outcome is to measure progression-free survival, which indicates how long patients remain free from disease progression after treatment. The study is interventional and is in Phase 3, indicating it is testing the efficacy of these treatments in a larger patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable or metastatic left-sided colorectal cancer who have wild-type KRAS, NRAS, and BRAF tumors.

Not a fit: Patients with a history of interstitial lung disease or those who are allergic to the study medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective first-line treatment option for patients with advanced left-sided colorectal cancer.

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

Eligibility criteria

Show full inclusion / exclusion 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)

Where this trial is running

Gilbert, Arizona and 234 other locations

+185 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 2026-06-13 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.