NCT04919226

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: ITM Solucin GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
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.
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

• Start date: 2021-12-21
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2021-06-09
• Last updated: 2025-09-10

Locations

42 sites across 10 countries: United States, Australia, China, France, Germany, India, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study