Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE

Running, not enrolling · Phase 3

Conditions studied: Neuroendocrine Tumors

In brief

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.

Key facts

Study ID

NCT04919226

Run by

ITM Solucin GmbH

People needed

259

Starts

2021-12-21

Expected to finish

2027-09-01

Last updated by the study team

2025-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is 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
• 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

Full record on ClinicalTrials.gov

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