NCT03049189

Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: ITM Solucin GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	177Lu-edotreotide PRRT	PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
DRUG	Everolimus	Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
OTHER	Amino-Acid Solution	The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT

Timeline

• Start date: 2017-02-02
• Primary completion: 2024-11-27
• Completion: 2029-11-01
• First posted: 2017-02-09
• Last updated: 2026-04-06
• Results posted: 2026-04-06

Locations

52 sites across 14 countries: United States, Australia, Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, South Africa, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study