Status:
ACTIVE_NOT_RECRUITING
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
Lead Sponsor:
ITM Solucin GmbH
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compare...
Eligibility Criteria
Inclusion
- Patients aged ≥ 18 years.
- Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
- Somatostatin receptor-positive (SSTR+) disease.
Exclusion
- Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).
- Prior (Peptide Receptor Radionuclide Therapy) PRRT.
- Any major surgery within 4 weeks prior to randomization in the trial.
- Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
- Other known malignancies.
- Serious non-malignant disease.
- Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.
- Pregnant or breastfeeding women.
- Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.
Key Trial Info
Start Date :
December 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2027
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT04919226
Start Date
December 21 2021
End Date
September 1 2027
Last Update
September 10 2025
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford Cancer Center
Palo Alto, California, United States, 94305
2
University of Colorado Hospital, Nuclear Medicine
Aurora, Colorado, United States, 80045
3
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215