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)

Protocol # :
Neuroendocrine Tumors
Disease Sites
Small Intestine
Other Digestive Organ
Other Endocrine System
Principal Investigator
Perez, Kimberly
Site Research Nurses
Duarte, Kimberly
Graham, Christopher
Jones, Carolyn
McGoldrick, Hannah, Cíara
Ritterband, Lauren
Sawin, Mark

Trial Description

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 Requirements

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.