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

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04919226

Patient View

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

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.

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