Overview

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

Status:
Recruiting
Trial end date:
2029-06-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ITM Solucin GmbH
Collaborators:
ABX CRO
PSI CRO
Treatments:
Edotreotide
Everolimus
Octreotide
Pharmaceutical Solutions
Sirolimus
Criteria
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.).