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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: 13 Aug 2026

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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

  • 10 Aug 2026 According to a ITM Isotope Technologies Munich media release, The Company remains confident in the potential of ITM-11 and is reviewing the FDAs feedback to determine the most appropriate path forward. The Company intends to resubmit to complete the review of the NDA.
  • 10 Aug 2026 According to a ITM Isotope Technologies Munich media release, The CRL stated that the FDA is unable to approve the NDA in its present form and cited CMC- and third-party commercial facility-related items that must be addressed before the application can be approved. The FDA did not identify any concerns regarding the clinical or nonclinical data package or safety profile of ITM-11. ITM is reviewing the agencys feedback and assessing the appropriate next steps with the relevant external parties.
  • 10 Aug 2026 According to a ITM Isotope Technologies Munich media release, company announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on August 7, 2026, regarding its New Drug Application (NDA) for 177Lu-edotreotide (ITM-11), an investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

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