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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment259 (actual)
SponsorITM Solucin GmbH
Industry-sponsored
Drugs / interventions177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT, CAPTEM (Capecitabine and Temozolomide), Amino-Acid Solution, Everolimus, FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Locations42 sites (Australia, China, France, Germany, India, Italy, Netherlands, Spain and more)
Trial IDNCT04919226 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

  • 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
  • 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

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. 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.