Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
Sponsor: ITM Solucin GmbH
ClinicalTrials ID:NCT04919226
This study assesses the efficacy and safety of 177Lu-Edotreotide PRRT versus standard care in SSTR+ GEP-NETs. Eligible patients are adults with unresectable, well-differentiated tumors. Exclusions include prior PRRT and significant organ dysfunction. Interventions include 177Lu-Edotreotide, CAPTEM, Everolimus, FOLFOX, and an amino-acid solution.
Patient Parameters
| Parameter | Options |
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Program Overview
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 compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford Cancer Center | 94305 | Palo Alto | California |
| University of Colorado Hospital, Nuclear Medicine | 80045 | Aurora | Colorado |
| H. Lee Moffitt Cancer Center & Research Institute | 33612 | Tampa | Florida |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Mayo Clinic - Rochester, Department of Oncology | 55905 | Rochester | Minnesota |
| Washington University Alvin J. Siteman Cancer Center | 63110 | Saint Louis | Missouri |
| Memorial Sloan-Kettering Cancer Center | 10065 | New York | New York |
| ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute | 10128 | New York | New York |
| Duke University School of Medicine, Duke Cancer Institute | 27710 | Durham | North Carolina |
| Oregon Health and Science University | 97239-3098 | Portland | Oregon |
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