DRUG
177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
Status
Active, not recruiting
Phase
Phase 3
Enrollment
259
Locations
42
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
CAPTEM (Capecitabine and Temozolomide)
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
OTHER
Amino-Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
DRUG
Everolimus
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
DRUG
FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
Timeline
From registration to results.
First posted
Jun 9, 2021
Study start
Dec 21, 2021
Primary completion
Jun 2027
Study completion
Sep 2027
Results posted
Not reported
Registry updated
Sep 10, 2025
Outcomes
What the study measures.
Primary outcomes
Progression-Free Survival
Time frame · Every 12 weeks from randomization until disease progression or death whichever occurs earlier, during the time necessary to observe 148 Progression Free Survival (PFS) events.
PFS (Progression-Free Survival), defined as the time from randomization until documented RECIST v1.1 (Response evaluation criteria in solid tumors) progression or death, whichever occurs first.
Secondary outcomes
Overall Survival
Time frame · Up to 3 years after disease progression, or to a maximum of 5 years after randomization
OS (Overall Survival), defined as the time from randomization until death;
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
42 registered sites.
Australia · China · France · Germany · India · Italy · Netherlands · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Octreotide.
NCT IDStudyPhase / statusEnrollmentUpdated
Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor
National Cancer Institute (NCI) · Colorectal Neuroendocrine Tumor G1 · Gastric Neuroendocrine Tumor G1
Phase 3
Active, not recruiting
427
2026-07
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
Camurus AB · Gastro-enteropancreatic Neuroendocrine Tumor
Phase 3
Active, not recruiting
332
2026-07
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Debiopharm International SA · Acromegaly
Phase 3
Recruiting
119
2026-07
Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · ACTH · Cushing's Syndrome
Phase 2
Recruiting
80
2026-07
RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma
M.D. Anderson Cancer Center · Neuroendocrine Carcinoma · Islet Cell Carcinoma
Phase 2
Completed
67
2026-07
Effect of Insulin Lowering on Lipogenesis
Columbia University · Hyperinsulinemia · Insulin Resistance
Phase 1
Recruiting
25
2026-07
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Camurus AB · Acromegaly
Not applicable
Recruiting
200
2026-06
A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Effect on Pharmacokinetics Of Octreotide Acetate Tablets(T25)
Triastek (Shanghai) Limited · Acromegaly
Phase 1
Not yet recruiting
18
2026-06
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.