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


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Trial ID: NCT04919226


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.

Official Title

A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide 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

Stanford Investigator(s)

Carina Mari Aparici
Carina Mari Aparici

Clinical Professor, Radiology - Rad/Nuclear Medicine


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.


drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT

drug: CAPTEM (Capecitabine and Temozolomide)

other: Amino-Acid Solution

drug: Everolimus

drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
David Marcellus