A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor‑positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (COMPOSE)

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.

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.