Clinical trial
Phase 3
Interventional
Ages 18 and up
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
Run by ITM Solucin GmbH · NCT04919226 · Data updated 2026-11-12
Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2027-06.
The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 259 (actual) |
| Sponsor | ITM Solucin GmbH Industry-sponsored |
| Drugs / interventions | 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT, CAPTEM (Capecitabine and Temozolomide), Amino-Acid Solution, Everolimus, FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) |
| Locations | 42 sites (Australia, China, France, Germany, India, Italy, Netherlands, Spain and more) |
| Trial ID | NCT04919226 on ClinicalTrials.gov |
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Stanford Cancer Center
Palo Alto, California, United States -
University of Colorado Hospital, Nuclear Medicine
Aurora, Colorado, United States -
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States -
Dana Farber Cancer Institute
Boston, Massachusetts, United States -
Mayo Clinic - Rochester, Department of Oncology
Rochester, Minnesota, United States -
Washington University Alvin J. Siteman Cancer Center
St Louis, Missouri, United States
Show 36 more locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States -
ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute
New York, New York, United States -
Duke University School of Medicine, Duke Cancer Institute
Durham, North Carolina, United States -
Oregon Health and Science University
Portland, Oregon, United States -
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States -
Texas Oncology
Dallas, Texas, United States -
University of Texas MD Anderson Cancer Center
Houston, Texas, United States -
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States -
Royal North Shore Hospital
St Leonards, New South Wales, Australia -
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia -
Fudan University Shanghai Cancer Center
Shanghai, China -
Affiliated Hospital of Jiangnan University
Wuxi, China -
Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology
Pessac, Bordeaux, France -
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, Cedex, France -
Edouard Herriot Hospital, Medical Oncology Unit
Lyon, France -
IUCT Oncopole - Institut Universitaire du Cancer de Toulouse
Toulouse, France -
Charite - University Hospital Berlin
Berlin, Germany -
University Hospital Bonn, Department of Nuclear Medicine
Bonn, Germany -
University Hospital Erlangen, Department of Internal Medicine I - Endocrinology
Erlangen, Germany -
University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine
Essen, Germany -
HCG Cancer Centre, Medical Oncology
Bangalore, Karnataka, India -
All India Institute Of Medical Sciences, Nuclear Medicine
New Delhi, National Capital Territory of Delhi, India -
Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging
Mumbai, India -
University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine
Messina, Italy -
European Institute of Oncology (IEO), IRCCS
Milan, Italy -
University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology
Rome, Italy -
VU Medical Center (VUMC), Department of Medical Oncology
Amsterdam, Netherlands -
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands -
University Hospital Vall d'Hebron, Department of Medical Oncology
Barcelona, Spain -
ICO Hospitalet, Catalan Institute of Oncology
Barcelona, Spain -
University General Hospital Gregorio Maranon
Madrid, Spain -
University Hospital 12 de Octubre, Department of Gastroenterology
Madrid, Spain -
Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology
Oviedo, Spain -
University Hospital Complex of Santiago (CHUS)
Santiago de Compostela, Spain -
University and Polytechnic Hospital La Fe, Endocrinology
Valencia, Spain -
King's College Hospital
London, United Kingdom
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.