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

Source: https://onco.cc/trials/nct04919226/  
OnCo record `nct04919226` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of 177Lu-edotreotide, Temozolomide, Capecitabine, Everolimus, Leucovorin (folinic acid) and Oxaliplatin in neuroendocrine tumours, run by ITM Solucin GmbH, active and no longer recruiting.

## Summary

Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE is a phase 3 interventional study registered as NCT04919226 by ITM Solucin GmbH, with 259 participants enrolled, started 2021-12-21 and due to reach its primary completion in 2027-06. Interventions recorded: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT, CAPTEM (Capecitabine and Temozolomide), Everolimus and FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin).

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Also known as: COMPOSE
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04919226
- Phase: 3
- Setting: 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
- Sponsor: ITM Solucin GmbH
- Enrolled: 259

## Sources

- ClinicalTrials.gov NCT04919226: https://clinicaltrials.gov/study/NCT04919226

## Connected records

- cancers: [Grade 3 well-differentiated neuroendocrine tumour](https://onco.cc/cancers/grade-3-net/), [Neuroendocrine tumours](https://onco.cc/cancers/neuroendocrine/), [Pancreatic neuroendocrine tumours](https://onco.cc/cancers/pancreatic-net/), [Small intestinal neuroendocrine tumours](https://onco.cc/cancers/small-intestinal-net/)
- technologies: [Peptide receptor radionuclide therapy (PRRT)](https://onco.cc/technologies/prrt/), [Radioligand therapy (beta emitters)](https://onco.cc/technologies/radioligand-therapy/)
- drugs: [177Lu-edotreotide](https://onco.cc/drugs/itm-11/), [Capecitabine](https://onco.cc/drugs/capecitabine/), [Capecitabine + temozolomide (CAPTEM)](https://onco.cc/drugs/capecitabine-temozolomide/), [Everolimus](https://onco.cc/drugs/everolimus/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/), [Temozolomide](https://onco.cc/drugs/temozolomide/)
- companies: [ITM Isotope Technologies Munich](https://onco.cc/companies/itm/)
- ideas: [Dosimetry-personalised PRRT instead of four fixed cycles](https://onco.cc/ideas/idea-net-dosimetry-prrt/), [SSTR antagonist radioligands to increase tumour dose](https://onco.cc/ideas/idea-net-antagonist-ligands/)

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