πŸ›οΈ Verified NIH Record β€’ Updated 2025-09-03

Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (NCT04919226)

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

πŸ”΅ Active, Not Recruiting Phase3 πŸ’Š Investigational Drug / Biologic Sponsor: ITM Solucin GmbH

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Stanford Cancer Center β€” Palo Alto, California

Age range: 18 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (42 Sites)

Showing the first 25 of 42 sites.

  • Stanford Cancer Center β€” Palo Alto, California
  • University of Colorado Hospital, Nuclear Medicine β€” Aurora, Colorado
  • H. Lee Moffitt Cancer Center & Research Institute β€” Tampa, Florida
  • Dana Farber Cancer Institute β€” Boston, Massachusetts
  • Mayo Clinic - Rochester, Department of Oncology β€” Rochester, Minnesota
  • Washington University Alvin J. Siteman Cancer Center β€” St Louis, Missouri
  • Memorial Sloan-Kettering Cancer Center β€” New York, New York
  • ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute β€” New York, New York
  • Duke University School of Medicine, Duke Cancer Institute β€” Durham, North Carolina
  • Oregon Health and Science University β€” Portland, Oregon
  • Fox Chase Cancer Center β€” Philadelphia, Pennsylvania
  • Texas Oncology β€” Dallas, Texas
  • University of Texas MD Anderson Cancer Center β€” Houston, Texas
  • University of Utah, Huntsman Cancer Institute β€” Salt Lake City, Utah
  • Royal North Shore Hospital β€” St Leonards, New South Wales
  • Peter MacCallum Cancer Centre β€” Melbourne, Victoria
  • Fudan University Shanghai Cancer Center β€” Shanghai,
  • Affiliated Hospital of Jiangnan University β€” Wuxi,
  • Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology β€” Pessac, Bordeaux
  • Nantes University Hospital Center - Hotel Dieu Hospital β€” Nantes, Cedex
  • Edouard Herriot Hospital, Medical Oncology Unit β€” Lyon,
  • IUCT Oncopole - Institut Universitaire du Cancer de Toulouse β€” Toulouse,
  • Charite - University Hospital Berlin β€” Berlin,
  • University Hospital Bonn, Department of Nuclear Medicine β€” Bonn,
  • University Hospital Erlangen, Department of Internal Medicine I - Endocrinology β€” Erlangen,

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—