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RecruitingLast updated: 2 February 2024

COMPOSE: This phase III study is trying to understand how safe and effective radiation-based treatment (177Lu-Edotreotide PRRT) compared to best standard of care treatment in people with neuroendocrine tumours that originate in the stomach, intestines or pancreas.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

Clinical summary

Summary

To be eligible for this study you will have well-differentiated aggressive grade 2 or grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin. Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive Peptide Receptor Radionuclide Therapy (PRRT). PRRT using 177Lu-edotreotide with a defined number of cycles will be administered. The Amino-Acid Solution to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution. In the Active Comparator Arm, participants will receive best standard of care treatment of the investigator's choice of either CAPTEM (Capecitabine-Temozolomide), Everolimus, FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin).

Conditions

This trial is treating patients with neuroendocrine tumours of gastroenteric or pancreatic origin

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

III

Trial Acronym

COMPOSE

More information

Trial Identifiers

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Trial sponsor

ITM Solucin GmbH

Scientific 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

Eligibility

Inclusion

  • 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

  • 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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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