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Lutetium (177Lu) Edotreotide versus Best Standard of Care in Well-differentiated Aggressive Grade 2 and Grade 3 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
EU CTIS ID: 2024-510812-64-00
What this study is testing
To demonstrate the efficacy of PRRT with lutetium (177Lu) edotreotide in the treatment of aggressive Grade 2 (G2; Ki67 between 15 and 20, both inclusive) and Grade 3 (G3; Ki-67 above 20 up to 55, inclusive) SSTR+ GEP-NETs compared to best standard of care (Investigator's choice [from the protocol comparator list]).
- 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. Patients aged ≥18 years.
- 2. Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). At least 1 measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
- 3. Somatostatin receptor-positive (SSTR+) disease.
You likely can't join if
- 1. Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).
- 2. Prior (Peptide Receptor Radionuclide Therapy) PRRT.
- 3. Any major surgery within 4 weeks prior to randomization in the trial.
- 4. Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
- 5. Other known malignancies.
- 6. Serious non-malignant disease.
See the full eligibility criteria
- 1. Patients aged ≥18 years.
- 2. Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). At least 1 measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
- 3. Somatostatin receptor-positive (SSTR+) disease.
- 1. Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).
- 2. Prior (Peptide Receptor Radionuclide Therapy) PRRT.
- 3. Any major surgery within 4 weeks prior to randomization in the trial.
- 4. Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
- 5. Other known malignancies.
- 6. Serious non-malignant disease.
- 7. Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.
- 8. Pregnant or breastfeeding women.
- 9. Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- India
- Australia
- China
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 Kingdom; United States; India; Australia; China. 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.