NCT04919226Active, not recruitingPhase 3
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide 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
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 259 (actual)
- First submitted
- 1 Jun 2021
- Start date
- 21 Dec 2021
- Primary completion date
- Jun 2027
- Lead sponsor
- ITM Solucin GmbH
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- NCT number
- NCT04919226
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 259
- From 21 Dec 2021 to the primary completion date, Jun 2027
- 42 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).
- Other known malignancies.
- Serious non-malignant disease.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (42)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Affiliated Hospital of Jiangnan University Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Charite - University Hospital Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| University Hospital Bonn, Department of Nuclear Medicine Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| University Hospital Erlangen, Department of Internal Medicine I - Endocrinology Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| ICO Hospitalet, Catalan Institute of Oncology Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| University Hospital Vall d'Hebron, Department of Medical Oncology Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| University General Hospital Gregorio Maranon Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| University Hospital 12 de Octubre, Department of Gastroenterology Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| University Hospital Complex of Santiago (CHUS) Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| University and Polytechnic Hospital La Fe, Endocrinology Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Edouard Herriot Hospital, Medical Oncology Unit Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Nantes University Hospital Center - Hotel Dieu Hospital Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| IUCT Oncopole - Institut Universitaire du Cancer de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| HCG Cancer Centre, Medical Oncology Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| All India Institute Of Medical Sciences, Nuclear Medicine Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| European Institute of Oncology (IEO), IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| VU Medical Center (VUMC), Department of Medical Oncology Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Erasmus University Medical Center Rotterdam Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| University of Colorado Hospital, Nuclear Medicine Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Texas Oncology Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Duke University School of Medicine, Duke Cancer Institute Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stanford Cancer Center Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Mayo Clinic - Rochester, Department of Oncology Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Utah - Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Washington University Alvin J. Siteman Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| H Lee Moffitt Cancer Center & Research Institute Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.