Phase 3 Colorectal Cancer Trial, Recruiting NCT06662786 Sponsor: Janssen Research & Development, LLC Condition: Colorectal Cancer
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Phase 3 Colorectal Cancer Trial, Recruiting

NCT06662786
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with a type of bowel cancer called adenocarcinoma, located on the left side of the colon or rectum, and the cancer cannot be removed by surgery or has spread to other parts of the body
  • Your tumour has been tested and does not have changes (mutations) in genes called KRAS, NRAS, or BRAF — these are sometimes called "wild-type" results
  • You are willing to provide a fresh tumour tissue sample (biopsy) for the study
  • Your cancer can be measured using standard medical scans, following specific guidelines called RECIST v1.1
  • You have not yet received any treatment (such as chemotherapy) for cancer that has spread or cannot be removed — though previous treatment given before or after surgery for earlier-stage cancer is allowed, as long as it finished more than 12 months before the cancer came back or spread
  • You are in good enough general health to carry out daily activities with little or no limitation (this is measured on a standard scale called ECOG performance status 0 or 1)

Who may not be able to join:

  • You have a history of, or currently have, a lung condition involving scarring or inflammation of the lung tissue (such as interstitial lung disease, pneumonitis, or pulmonary fibrosis), or this cannot be ruled out based on scans done at the start of the study
  • You have a known allergy or serious reaction to any of the study drugs or their ingredients, including amivantamab, cetuximab, or the chemotherapy combinations called mFOLFOX6 or FOLFIRI
  • You have, or have previously had, another type of cancer that could affect the results of this study or interfere with your safety during treatment (confirm with trial site)
  • Your tumour has been found to have a specific feature related to how cells repair DNA, known as mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H), or your tumour tests positive for a protein called HER2
  • You have previously been treated with any therapy that targets specific proteins involved in cancer growth, known as EGFR, MET, or VEGF

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
18 October 2024
Est. completion
15 December 2028

Where this trial is recruiting

🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇳🇱 Netherlands 🇵🇱 Poland Puerto Rico 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov