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Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE)
EU CTIS ID: 2023-510444-21-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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)
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- Switzerland
- United Kingdom
- South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; Switzerland; United Kingdom; South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.