Clinical Trial

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

Study acronym: COMPOSE
Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 28 amendments
This ClinicalTrials.gov record has been amended 28 times since 2021-06-08; most recent amendment 2025-09-03.
Status change: Recruiting → Active, Not Recruiting 2025-05-26
Status change: Not Yet Recruiting → Recruiting 2022-01-13
Trial Details
NCT Number NCT04919226
Lead Sponsor ITM Solucin GmbH
Conditions Neuroendocrine Tumors
Enrollment 259 participants
Start Date 2021-12-21
Primary Completion 2027-06 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-09-10