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Can a targeted drug keep working after cancer progresses? new trial aims to find out

NCT ID NCT07389265

Disease control Sponsor: University of Campania Luigi Vanvitelli Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This Phase 3 trial tests whether continuing cetuximab (a targeted antibody) with chemotherapy after first-line treatment stops working can improve outcomes in metastatic colorectal cancer. About 480 adults whose tumors have specific genetic markers (RAS and BRAF wild-type) will receive either cetuximab plus chemo or bevacizumab plus chemo. The study measures tumor response, survival, and safety, with regular scans and blood tests.

What this could mean

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

Active substance
Cetuximab (Erbitux) combined with chemotherapy
What this could lead to
If successful, this could show that continuing cetuximab beyond initial progression helps control metastatic colorectal cancer better than switching to a different drug.
What could go wrong
This is a Phase 3 trial, but results may not confirm a benefit. The treatment involves chemotherapy side effects and requires ongoing medication, not a cure.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 480 people

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

Started

Oct 2025

Expected to finish

Oct 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: 1. Histologically proven diagnosis of colorectal adenocarcinoma. 2. Diagnosis of metastatic disease. 3. Efficacy of a first line therapy containing anti-EGFR drug with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1) or a prolonged (at least 6 months) stable disease. 4. Progression to first line therapy. 5. RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis. 6. RAS (NRAS and KRAS exon 2,3 and 4), BRAFV600E, PIK3CA, EGFR ECD wild-type and HER2 not amplified in liquid biopsy at the time of screening (according to NGS, Foundation/Roche). 7. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, vers.1.1). 8. Male or female patients ≥ 18 years of age. 9. ECOG Performance Status 0-1. 10. Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment as defined by the following parameters: Bone marrow: * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L * Hemoglobin (Hgb) ≥ 9 g/dL * Platelets ≥ 100 x 109/L Liver function: • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and ALT (SGPT) ≤ 2.5 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN Renal function: • Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min 11. If female and of childbearing potential\*, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment. \*A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. 12. If female and of childbearing potential, or if male, agreement to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 6 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate. 13. Signed informed consent obtained before screening. Exclusion Criteria: 1. Any contraindication to the use of cetuximab, bevacizumab, Irinotecan, 5-FU, oxaliplatin, folic acid. 2. Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease. 3. Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix. 4. Pregnancy (exclusion to be ascertained by a beta hCG test). 5. Breastfeeding. 6. Fertile women (\<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception. 7. Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study, Grade III or IV heart failure (NYHA classification). 8. Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin. 9. Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study. 10. Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study. 11. Known or clinically suspected brain metastases. 12. History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhea. 13. Severe, non-healing wounds, ulcers or bone fractures. 14. Marked proteinuria (nephrotic syndrome). 15. Known DPD deficiency (specific screening not required). 16. Known history of alcohol or drug abuse. 17. A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study. 18. Absent or restricted legal capacity. 19. Patients with known dMMR or MSI-H tumors who are eligible for approved immune checkpoint inhibitor therapy will be excluded from the trial, unless ICI therapy is contraindicated or declined by the patient. This ensures alignment with current standard of care.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Metastatic colorectal cancer (MCRC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O. 'Pia Fondazione Cardinale G.Panico'

    NOT_YET_RECRUITING

    Tricase, Italy

  • A.O.U. Careggi

    NOT_YET_RECRUITING

    Florence, Italy

  • A.O.U. Federico II

    NOT_YET_RECRUITING

    Naples, Italy

  • A.O.U. Ospedali Riuniti

    NOT_YET_RECRUITING

    Ancona, Italy

  • A.O.U. Pisana

    NOT_YET_RECRUITING

    Pisa, Italy

  • A.O.U. Sassari

    NOT_YET_RECRUITING

    Sassari, Italy

  • A.O.U. dell'Università degli studi della Campania 'Luigi Vanvitelli'

    RECRUITING

    Naples, Italy

  • AORN S. Giuseppe Moscati

    NOT_YET_RECRUITING

    Avellino, Italy

  • ARNAS Civico - Di Cristina-Benfratelli - P. O. 'Civico e Benfratelli'

    NOT_YET_RECRUITING

    Palermo, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    NOT_YET_RECRUITING

    Milan, Italy

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    NOT_YET_RECRUITING

    Catanzaro, Italy

  • Azienda USL IRCCS di Reggio Emilia

    NOT_YET_RECRUITING

    Reggio Emilia, Italy

  • Casa di Cura Villa Maria

    NOT_YET_RECRUITING

    Mirabella Eclano, Italy

  • Casa di cura Macchiarella

    NOT_YET_RECRUITING

    Palermo, Italy

  • Centro di Riferimento Oncologico (C.R.O.) IRCCS

    NOT_YET_RECRUITING

    Aviano, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    NOT_YET_RECRUITING

    Milan, Italy

  • Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza

    NOT_YET_RECRUITING

    San Giovanni Rotondo, Italy

  • Fondazione Poliambulanza Istituto Ospedaliero

    NOT_YET_RECRUITING

    Brescia, Italy

  • Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS

    NOT_YET_RECRUITING

    Roma, Italy

  • Hospital General Universitario Santa Lucía

    NOT_YET_RECRUITING

    Cartagena, Spain

  • Hospital Universitari Vall d´Hebron

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Universitario Gregorio Marañón

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Universitario Marqués de Valdecilla

    NOT_YET_RECRUITING

    Santander, Spain

  • Hospital Universitario Regional de Málaga

    NOT_YET_RECRUITING

    Málaga, Spain

  • Hospital Universitario Reina Sofía

    NOT_YET_RECRUITING

    Córdoba, Spain

  • Hospital Universitario Virgen de las Nieves

    NOT_YET_RECRUITING

    Granada, Spain

  • Hospital Universitario de Navarra

    NOT_YET_RECRUITING

    Pamplona, Spain

  • Hospital del Mar

    NOT_YET_RECRUITING

    Barcelona, Spain

  • IRCCS I.N.T. 'Fondazione G. Pascale'

    NOT_YET_RECRUITING

    Naples, Italy

  • IRCCS Istituto Tumori "Giovanni Paolo II"

    NOT_YET_RECRUITING

    Bari, Italy

  • IRCCS Istituto clinico Humanitas

    NOT_YET_RECRUITING

    Rozzano, Italy

  • IRCCS Ospedale Sacro Cuore Don Calabria

    NOT_YET_RECRUITING

    Veneto, Italy

  • Instituto Catalán de Oncología. Hospital Duran i Reynals

    NOT_YET_RECRUITING

    L'Hospitalet de Llobregat, Spain

  • Istituto Europeo di Oncologia

    NOT_YET_RECRUITING

    Milan, Italy

  • Istituto Oncologico Veneto IRCCS

    NOT_YET_RECRUITING

    Padova, Italy

  • Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori'

    NOT_YET_RECRUITING

    Meldola, Italy

  • Nome EnteA.R.N.A.S. Garibaldi - P.O. Garibaldi-Nesima

    NOT_YET_RECRUITING

    Catania, Italy

  • Ospedale IRCCS 'Saverio de Bellis'

    NOT_YET_RECRUITING

    Castellana Grotte, Italy

  • Ospedale San Giuseppe Moscati

    NOT_YET_RECRUITING

    Statte, Italy

  • P.O. 'Vito Fazzi'

    NOT_YET_RECRUITING

    Lecce, Italy

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Other studies related to the condition(s) this trial covers.