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Radioactive drug aims to shrink Hard-to-Treat gut tumors

NCT ID NCT04919226

Disease control Sponsor: ITM Solucin GmbH Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 trial tests a radioactive drug called 177Lu-Edotreotide against standard chemotherapy for people with aggressive neuroendocrine tumors of the gut or pancreas. The drug targets tumor cells and delivers radiation directly. About 259 participants will be followed to see if the treatment slows tumor growth and improves survival.

What this could mean

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

Active substance
177Lu-Edotreotide (a radioactive drug that targets tumor cells)
What this could lead to
If successful, this treatment could slow tumor growth and extend survival for people with aggressive neuroendocrine tumors that are hard to treat.
What could go wrong
This is a Phase 3 trial, but results are not yet final. The treatment involves radiation, which can cause side effects like kidney damage or low blood counts. It may not work for everyone.

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

259 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Patients aged ≥ 18 years. * Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI). * Somatostatin receptor-positive (SSTR+) disease. Exclusion Criteria: * Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin). * Prior (Peptide Receptor Radionuclide Therapy) PRRT. * Any major surgery within 4 weeks prior to randomization in the trial. * Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization. * Other known malignancies. * Serious non-malignant disease. * Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments. * Pregnant or breastfeeding women. * Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine neoplasm digestive system neuroendocrine tumor, grade 1/2 neuroendocrine neoplasm

As listed by the trial registrant

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

Neuroendocrine tumors

Contacts and locations

Locations

  • Affiliated Hospital of Jiangnan University

    Wuxi, 214122, China

  • All India Institute Of Medical Sciences, Nuclear Medicine

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology

    Oviedo, 33011, Spain

  • Charite - University Hospital Berlin

    Berlin, 13353, Germany

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University School of Medicine, Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Edouard Herriot Hospital, Medical Oncology Unit

    Lyon, 69003, France

  • Erasmus University Medical Center Rotterdam

    Rotterdam, 3015 GD, Netherlands

  • European Institute of Oncology (IEO), IRCCS

    Milan, 20141, Italy

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497, United States

  • Fudan University Shanghai Cancer Center

    Shanghai, 200000, China

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612, United States

  • HCG Cancer Centre, Medical Oncology

    Bangalore, Karnataka, 560027, India

  • Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology

    Pessac, Bordeaux, 33604, France

  • ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute

    New York, New York, 10128, United States

  • ICO Hospitalet, Catalan Institute of Oncology

    Barcelona, 199-203, Spain

  • IUCT Oncopole - Institut Universitaire du Cancer de Toulouse

    Toulouse, 31059, France

  • King's College Hospital

    London, SE5 9RS, United Kingdom

  • Mayo Clinic - Rochester, Department of Oncology

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Nantes University Hospital Center - Hotel Dieu Hospital

    Nantes, Cedex, 44093, France

  • Oregon Health and Science University

    Portland, Oregon, 97239-3098, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, VIC 3000, Australia

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • Stanford Cancer Center

    Palo Alto, California, 94305, United States

  • Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging

    Mumbai, 400012, India

  • Texas Oncology

    Dallas, Texas, 75246, United States

  • University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine

    Essen, 45147, Germany

  • University General Hospital Gregorio Maranon

    Madrid, 28007, Spain

  • University Hospital 12 de Octubre, Department of Gastroenterology

    Madrid, 28041, Spain

  • University Hospital Bonn, Department of Nuclear Medicine

    Bonn, 53127, Germany

  • University Hospital Complex of Santiago (CHUS)

    Santiago de Compostela, 15706, Spain

  • University Hospital Erlangen, Department of Internal Medicine I - Endocrinology

    Erlangen, 91054, Germany

  • University Hospital Vall d'Hebron, Department of Medical Oncology

    Barcelona, 08035, Spain

  • University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology

    Rome, 00168, Italy

  • University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine

    Messina, 98125, Italy

  • University and Polytechnic Hospital La Fe, Endocrinology

    Valencia, 46026, Spain

  • University of Colorado Hospital, Nuclear Medicine

    Aurora, Colorado, 80045, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Utah, Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • VU Medical Center (VUMC), Department of Medical Oncology

    Amsterdam, 1081-HV, Netherlands

  • Washington University Alvin J. Siteman Cancer Center

    St Louis, Missouri, 63110, United States

More trials for these conditions

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