Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ITM Solucin GmbH
• Treatments: Capecitabine; Edotreotide; Everolimus; Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin; Pharmaceutical Solutions; Temozolomide

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.