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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)

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Trial Profile

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: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2025

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At a glance

  • Drugs Lu-177 octreotide (Primary) ; Everolimus
  • Indications Gastro-enteropancreatic neuroendocrine tumour
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPETE
  • Sponsors ITM Solucin

Most Recent Events

  • 13 Nov 2025 According to a itm Group media release, THE announced that the U.S. Food and Drug Administration (FDA) completed its filing review and accepted the company's New Drug Application (NDA) for n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026.
  • 25 Oct 2025 According to ITM Group media release, data from the trial were presented at the 2025 North American Neuroendocrine Tumor Society (NANETS) Annual Multidisciplinary NET Medical Symposium
  • 25 Oct 2025 Results presented in the ITM Group media release.

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