{"entity":{"id":"nct04919226","kind":"trial","name":"Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE","aka":[],"tldr":"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).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04919226","url":"https://clinicaltrials.gov/study/NCT04919226"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":[],"targets":[],"drugs":["itm-11","temozolomide","capecitabine","everolimus","leucovorin","oxaliplatin"],"companies":["itm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"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,"outcomes":[]},"route":"/trials/nct04919226/","neighbours":{"cancer":[{"id":"neuroendocrine","kind":"cancer","name":"Neuroendocrine tumours","route":"/cancers/neuroendocrine/"}],"drug":[{"id":"itm-11","kind":"drug","name":"177Lu-edotreotide","route":"/drugs/itm-11/"},{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"everolimus","kind":"drug","name":"Everolimus","route":"/drugs/everolimus/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"},{"id":"temozolomide","kind":"drug","name":"Temozolomide","route":"/drugs/temozolomide/"}],"company":[{"id":"itm","kind":"company","name":"ITM Isotope Technologies Munich","route":"/companies/itm/"}]}}