Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE)
- Conditions
- euroendocrine tumours of gastroenteric or pancreatic originMedDRA version: 20.0Level: PTClassification code: 10077559Term: Gastroenteropancreatic neuroendocrine tumour disease Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-510444-21-00
- Lead Sponsor
- ITM Solucin GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 324
1. Written informed consent, 2. Male or female =18 years of age, 3. 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), 4. Measurable disease per RECIST 1.1, 5. Somatostatin receptor positive (SSTR+) disease, 6. 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)
1. Known hypersensitivity to edotreotide or everolimus, 10. Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments, 11. Pregnant or breast-feeding women, 12. 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.), 2. Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative., 3. Prior exposure to any peptide receptor radionuclide therapy (PRRT), 4. Prior therapy with mTor inhibitors, 5. Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy., 6. Therapy with an investigational compound and/or medical device within 30 days prior to randomization, 7. Indication for surgical lesion removal with curative potential, 8. Planned alternative therapy (for the period of study participation), 9. Serious non-malignant disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the efficacy of PRRT with 177Lu-edotreotide to prolong progression-free survival (PFS) in patients with inoperable, progressive, SSTR+ GEP-NET, compared to everolimus;Secondary Objective: 1. To assess objective response rates (ORR), defined as the proportion of patients achieving partial response (PR) or complete response (CR) as best outcome, after treatment with 177Lu-edotreotide compared to everolimus, 2. To assess overall survival (OS), defined as the time from the date of randomisation until death;Primary end point(s): 1. Progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method