177Lu-edotreotide vs. everolimus in GEP-NET – COMPETE
Research type
Research Study
Full title
A prospective, randomised, Controlled, Open-label, Multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium 177-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).
IRAS ID
216075
Contact name
Shaunak Navalkissoor
Contact email
Sponsor organisation
ITM Solucin GmbH
Eudract number
2016-001897-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 30 days
Research summary
Patients with inoperable, progressive, somastatin receptor-positive neuroendocrine tumours of gastroenteric or pancreatic origin, and with a life expectancy of greater than 6 months, are the target population for this study.
Patients enrolled in the trial will be randomised 2:1 to receive either Peptide Receptor Radionuclide Therapy with 177Lu-edotreotide or the current standard of care treatment, Everolimus.
The investigational drug 177Lu-edotreotide is a radioactive pharmaceutical that exposes high radiation directly to tumour cells and destroys tissue affected by cancer whereas effect on surrounding tissue is limited.
Patients will receive either a maximum of 4 doses of 177Lu-edotreotide, administered at 3 monthly intervals for up to 9 months, or, everolimus, administered daily for up to 24 months.
Study visits will be monthly in the first 12 months, thereafter 3-monthly until end of study at month 24.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/0451
Date of REC Opinion
20 Apr 2017
REC opinion
Further Information Favourable Opinion