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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2024

Interventions

  • Drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
    • Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.
  • Drug: CAPTEM (Capecitabine and Temozolomide)
    • Best standard of care treatment (investigator’s choice [from the protocol comparator list]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
  • Other: Amino-Acid Solution
    • The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
  • Drug: Everolimus
    • Best standard of care treatment (investigator’s choice [from the protocol comparator list]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
  • Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
    • Best standard of care treatment (investigator’s choice [from the protocol comparator list]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.

Arms, Groups and Cohorts

  • Experimental: Peptide Receptor Radionuclide Therapy (PRRT) Arm
  • Active Comparator: CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)

Clinical Trial Outcome Measures

Primary Measures

  • Progression-Free Survival
    • Time Frame: Every 12 weeks from randomization until disease progression or death whichever occurs earlier, during the time necessary to observe 148 Progression Free Survival (PFS) events.
    • PFS (Progression-Free Survival), defined as the time from randomization until documented RECIST v1.1 (Response evaluation criteria in solid tumors) progression.

Secondary Measures

  • Overall Survival
    • Time Frame: Up to 2 years after disease progression
    • OS (Overall Survival), defined as the time from randomization until death;

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ITM Solucin GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Nicolas Schneider, Dr, info-solucin@itm-radiopharma.com

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