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Can a biomarker test unlock better treatment for Right-Sided colon cancer?

NCT ID NCT07094893

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase 4 trial is for people with advanced colorectal cancer that started on the right side of the colon and has a normal RAS gene. Researchers want to see if adding the targeted drug cetuximab to standard chemotherapy helps shrink tumors more than chemotherapy alone or with bevacizumab. The study will also check if a biomarker test (EREG/AREG) can predict who benefits most. About 280 adults will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cetuximab (anti-EGFR drug) combined with chemotherapy (irinotecan, oxaliplatin, 5-FU, capecitabine) and/or bevacizumab
What this could lead to
If successful, this could show that a biomarker test (EREG/AREG) helps identify which patients with right-sided colon cancer benefit from adding cetuximab to standard chemotherapy, potentially improving tumor shrinkage and survival.
What could go wrong
This trial is not yet recruiting and is relatively small (280 participants). The benefit may be limited to a specific biomarker subgroup, and anti-EGFR drugs can cause skin reactions and other side effects. Results may not apply to all colorectal cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for Registration: * Age ≥18 years * Biopsy-confirmed adenocarcinoma of the colon with a right primary tumour location * aCRC defined as either M1 or locally inoperable disease * Tumour RAS status either wild-type (by local testing) or unknown * Fit for combination chemotherapy plus anti-EGFR agent * Sufficient tumour material for EREG/AREG analysis * Written informed consent for registration Exclusion Criteria for Registration * Tumour RAS-mutation present * Prior chemotherapy for aCRC * Prior anti-EGFR agent therapy Inclusion Criteria for Randomisation: * Registered in ARIEL-ENGIC * Local testing confirms tumour RAS-wt status * ARIEL-ENGIC central testing confirms tumour EREG/AREG high * Tumour measurable by RECIST v1.1 criteria on CT scan * Participants have had CT scan within the timeframes stipulated (If there is a contrast reaction, then non-contrast CT with MRI is acceptable, assuming at least one of these modalities shows measurable disease at baseline for ETS evaluation and both modalities are repeated at the trial timepoints at week 8 and 16 and every 8 weeks until disease progression.) * Pre-randomisation laboratory tests : * Neutrophils ≥1.5 x109/l and platelet count ≥100 x109/l * Serum bilirubin ≤ 1.25 x upper limit of normal (ULN), alkaline phosphatase * 5x ULN, and serum transaminase (either AST or ALT) ≤ 2.5 x ULN * Estimated creatinine clearance ≥50ml/min (creatinine clearance estimated as per local practice) * WHO performance status (PS) 0, 1 or 2 * Fit for combination chemotherapy plus anti-EGFR agent * Life expectancy of at least 12 weeks * Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. * Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception * Written informed consent for randomization. Exclusion Criteria for Randomisation: * Participant has received more than one cycle of chemotherapy since registration * Participants with history of hypersensitivity to any component of their proposed trial treatment regimen or any of their excipients * Participants in receipt of live vaccine within four weeks prior to randomisation * Participants with a history interstitial pneumonitis/idiopathic lung disease (ILD) or pulmonary fibrosis * Participants with a history of keratitis, ulcerative keratitis or severe dry eye * Participants with a history of severe skin reaction which in the clinicians' opinion could be exacerbated by EGFR Mab (cf Steven's Johnson Syndrome) * Complete dihydropyrimidine dehydrogenase (DPYD) deficiency * Untreated brain metastases or spinal cord compression or primary brain tumours * History or evidence upon physical examination of CNS disease unless adequately treated * Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration * Clinically significant (e.g. active) cardiovascular disease for example cerebrovascular accidents, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication * Treatment with any investigational drug within 30 days prior to enrolment or 2 investigational agent half-lives (whichever is longer) * Other co-existing malignancies or malignancies diagnosed within the last 5 years that are likely to have an impact upon survival or treatment delivery * Known human immunodeficiency virus (HIV) * Has documented presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to enrolment * Has a positive hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to enrolment. Note: Participants with a positive HCV antibody test result due to prior resolved disease can be randomised, only if a confirmatory HCV RNA test is obtained - Definite contraindications for the use of corticosteroids and antihistamines as premedication. * Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies. * Woman pregnant or lactating or expecting to conceive children within the projected duration of the study through 6 months after the last dose of bevacizumab and/or fluorouracil.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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