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Active, Not Recruiting

NCT Number: NCT04919226

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neuroendocrine Tumors Gastro-enteropancreatic neuroendocrine tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal North Shore Hospital, St Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT

Drug

Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.

Other names: 177Lu-DOTATOC 177Lu-Edo

CAPTEM (Capecitabine and Temozolomide)

Drug

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.

Amino-Acid Solution

Other

The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.

Other names: Arginine-Lysine Solution

Everolimus

Drug

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.

FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)

Drug

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.

Primary outcomes

  1. 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 or death, whichever occurs first.

Secondary outcomes

  1. Overall Survival

    Time frame: Up to 3 years after disease progression, or to a maximum of 5 years after randomization

    OS (Overall Survival), defined as the time from randomization until death;

Sponsors and collaborators

Lead sponsor

ITM Solucin GmbH

Industry

Registry information

Official study 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

Acronym: COMPOSE

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2021
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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