NETTER-2
Research type
Research Study
Full title
This is a multicenter, stratified, randomized, open-label comparator-controlled, Phase III study in patients with somatostatin receptor positive, well-differentiated G2 and G3, advanced GEP NETs, diagnosed within 6 months prior to screening, comparing treatment with Lutathera (7.4GBq/200 mCi x 4 administrations every 8± 1 weeks; cumulative dose: 29.6 GBq/800mCi) plus octreotide long-acting (30 mg every 8 weeks during Lutathera treatment and every 4 weeks after last Lutathera treatment) and high dose octreotide long-acting (60 mg every 4 weeks).
IRAS ID
269540
Contact name
Katherine Murtagh
Contact email
Sponsor organisation
Advanced Accelerator Applications SA
Eudract number
2019-001562-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 5 months, days
Research summary
Gastro-entero-pancreatic neuroendocrine tumour’s (GEP-NETs) are neoplasms that arise from cells of the endocrine (hormonal) and nervous systems and located in the gastro-intestinal tract. The main treatment for GEP-NETs is surgery to remove the primary and metastatic tumour(s); however, this is often not possible as GEP-NETs are frequently detected too late into their development. Where tumours are inoperable, patient treatment is focused on prolonging survival, improving and maintaining quality of life, controlling tumour growth, and controlling symptoms.
Current treatment for inoperable GEP-NETs involves somatostatin analogues (SSAs) such as Octreotide. Somatostatin is a hormone produced naturally by the body which binds to cells carrying somatostatin docking sites (receptors) and SSAs behave like somatostatin in that they bind to the same receptors. Lutathera (177Lutetium Dotatate) is a SSA attached to a radioactive element that emits high energy radiation that can destroy cells. Because this radionuclide is attached to the SSA, the radiation can be targeted to the receptors on the tumours site, and it is a form a targeted therapy.
Both treatments, Lutathera and octreotide long acting, are used to try and stop the disease from getting worse and perhaps to even reduce the size of tumours(s).This study is sponsored by Advanced Accelerator Applications (AAA) and investigates the efficacy and safety of Lutathera compared to high dose of octreotide in certain types of growing GEP-NET tumours that have been recently diagnosed, are inoperable and have somatostatin receptors. Approximately 222 patients will be recruited into this study and will either receive one treatment or the other. After their disease has progressed, patients will be followed up for up to 3 years. Patients receiving high dose octreotide may receive Lutathera after the disease progression.
Lutathera is currently approved in the EU, Canada, Israel and US for treatment of inoperable/metastatic, progressive, somatostatin receptor positive GEP-NET.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/1551
Date of REC Opinion
25 Nov 2019
REC opinion
Further Information Favourable Opinion