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

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 pop…