{"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":["COMPOSE"],"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","grade-3-net","pancreatic-net","small-intestinal-net"],"sections":[],"technologies":["prrt","radioligand-therapy"],"targets":[],"drugs":["itm-11","temozolomide","capecitabine","everolimus","leucovorin","oxaliplatin","capecitabine-temozolomide"],"companies":["itm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"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","started":"2021-12-21","startedType":"actual","enrolled":259,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04919226/","neighbours":{"cancer":[{"id":"grade-3-net","kind":"cancer","name":"Grade 3 well-differentiated neuroendocrine tumour","route":"/cancers/grade-3-net/"},{"id":"neuroendocrine","kind":"cancer","name":"Neuroendocrine tumours","route":"/cancers/neuroendocrine/"},{"id":"pancreatic-net","kind":"cancer","name":"Pancreatic neuroendocrine tumours","route":"/cancers/pancreatic-net/"},{"id":"small-intestinal-net","kind":"cancer","name":"Small intestinal neuroendocrine tumours","route":"/cancers/small-intestinal-net/"}],"technology":[{"id":"prrt","kind":"technology","name":"Peptide receptor radionuclide therapy (PRRT)","route":"/technologies/prrt/"},{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"}],"drug":[{"id":"itm-11","kind":"drug","name":"177Lu-edotreotide","route":"/drugs/itm-11/"},{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"capecitabine-temozolomide","kind":"drug","name":"Capecitabine + temozolomide (CAPTEM)","route":"/drugs/capecitabine-temozolomide/"},{"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/"}],"idea":[{"id":"idea-net-dosimetry-prrt","kind":"idea","name":"Dosimetry-personalised PRRT instead of four fixed cycles","route":"/ideas/idea-net-dosimetry-prrt/"},{"id":"idea-net-antagonist-ligands","kind":"idea","name":"SSTR antagonist radioligands to increase tumour dose","route":"/ideas/idea-net-antagonist-ligands/"}]}}