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

Running, not enrolling · Phase 3

Conditions studied: Neuroendocrine Tumors

In brief

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).

Key facts

Study ID

NCT03049189

Run by

ITM Solucin GmbH

People needed

324

Starts

2017-02-02

Expected to finish

2029-11-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of well-differentiated neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET)
• Measurable disease per RECIST 1.1
• Somatostatin receptor positive (SSTR+) disease
• Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)

You may not qualify if…

• Known hypersensitivity to edotreotide or everolimus
• Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative
• Prior exposure to any peptide receptor radionuclide therapy (PRRT)
• Prior therapy with mTor inhibitors
• Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy
• Therapy with an investigational compound and/or medical device within 30 days prior to randomisation
• Indication for surgical lesion removal with curative potential
• Planned alternative therapy (for the period of study participation)
• Serious non-malignant disease
• Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments
• Pregnant or breast-feeding women
• Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.).

Where it is running

• Stanford University — Stanford, California, United States
• Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Excel Diagnostics & Nuclear Oncology Center — Houston, Texas, United States
• Royal North Shore Hospital — Saint Leonards, New South Wales, Australia
• Olivia Newton-John Cancer & Wellness Centre, Austin Hospital — Heidelberg, Victoria, Australia
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia
• Allgemeines Krankenhaus Wien — Vienna, Austria
• Institut Jules Bordet — Brussels, Belgium
• Universitaire Ziekenhuizen Leuven — Leuven, Belgium
• University Hospital Olomouc — Olomouc, Czechia
• University Hospital Motol — Prague, Czechia
• Hospices civils de Lyon — Bron, France
• Centre Jean Perrin — Clermont-Ferrand, France
• HP Hôpital Beaujon — Clichy, France
• Institut de Recherche en Cancérologie de Montpellier (IRCM) — Montpellier, France
• CHU de Nantes - Hôtel Dieu — Nantes, France
• IUCT-Oncopole — Toulouse, France
• Zentralklinik Bad Berka GmbH — Bad Berka, Germany
• Charité - Universitätsmedizin Berlin — Berlin, Germany
• Universitätsklinikum Bonn — Bonn, Germany
• Universitätsklinikum Erlangen — Erlangen, Germany
• Banner Health d.b.a. Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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