DRUG
177Lu-edotreotide PRRT
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
Status
Active, not recruiting
Phase
Phase 3
Enrollment
324
Locations
52
Results
Posted
Publications
1
Study 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).
Interventions
DRUG
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
DRUG
Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
OTHER
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
First posted
Feb 9, 2017
Study start
Feb 2, 2017
Primary completion
Nov 27, 2024
Study completion
Nov 2029
Results posted
Apr 6, 2026
Registry updated
Apr 6, 2026
Outcomes
Progression-Free Survival (PFS)
Time frame · From date of randomization until the date of first documented progression or death, assessed up to 30 months,
PFS determined as time elapsed between randomization, and the date of first objective report of tumor progression (evaluated by RECIST criteria v1.1) as evaluated by the Blinded Independent Central Review (BICR), or death.
Objective Response Rate (ORR)
Time frame · Up to 30 months
ORR will be assessed, defined as the proportion of participants achieving partial response (PR) or complete response (CR) as best outcome, after treatment with 177Lu-edotreotide compared to everolimus.
Overall Survival (OS)
Time frame · Overall Survival (OS) will be followed up for 5 years (60 months) after the End of Study (EOS)
From the date of randomisation until the date of death up to the up to the end of the 5 year post-study follow-up.
Eligibility
Inclusion Criteria: * 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) Exclusion Criteria: * 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.).
Study locations
Australia · Austria · Belgium · Czechia · France · Germany · Italy · Netherlands · Poland · South Africa · Spain · Switzerland · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Banner Health d.b.a. Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
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
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