Eine kontrollierte, klinische Studie zum Vergleich der Wirksamkeit und Sicherheit einer neuen Behandlungsmöglichkeit (Peptid-Rezeptor-Radionuklid-Therapie, PRRT) von Tumoren des Magen-Darm-Traktes und der Bauchspeicheldrüse im Vergleich zur gezielten molekularen Therapie mit der derzeitigen Standardbehandlung (Everolimus).

Drug: 177Lu-edotreotide PRRT;Drug: Everolimus;Other: Amino-Acid Solution

Gender: All
Maximum age: N/A
Minimum age: 18 Years

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.).