Clinical Trial 21383

• Overview

  Study Title:

  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)

  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.

  Objective:

  Primary objective: To demonstrate the efficacy of PRRT with lutetium (177Lu) edotreotide in the treatment of aggressive Grade 2 (G2; Ki67 between 15 and 20, both inclusive) and Grade 3 (G3; Ki-67 above 20 up to 55, inclusive) SSTR+ GEP-NETs compared to best standard of care (investigator s choice [from the protocol comparator list]). Secondary objectives: 1. To further demonstrate the efficacy of PRRT with lutetium (177Lu) edotreotide. 2. To assess the impact of PRRT with lutetium (177Lu) edotreotide on trial patient s health-related quality of life (HRQL) and neuroendocrine functional tumor symptoms during and after therapy in comparison to best standard of care. 3. To assess the safety and tolerability of PRRT with lutetium (177Lu) edotreotide in trial patients compared to control treatment options. Exploratory objectives: To assess the association of clinical/radiological outcomes with baseline characteristics, functional images and tumor gene profiling.

• Treatments

  Therapies:

  Chemotherapy (NOS); Therapy (NOS)

  Medications:

  177Lu-edotreotide (); 5-fluorouracil (); Not Applicable (); Oxaliplatin (); Temodal (Temozolomide); Temozolomide (); Xeloda (capecitabine); capecitabine (); eloxatin (Oxaliplatin); everolimus (RAD001); leucovorin ()

• Inclusion Criteria

  Inclusion Criteria:
  • Patients 18 years of age or more
  • 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.
  • Other criteria may apply

• Exclusion Criteria

  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
  • Other criteria apply

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