{"entity":{"id":"compete","kind":"trial","name":"COMPETE","aka":[],"tldr":"The first head-to-head trial of a radioligand against a targeted pill in neuroendocrine tumours; the radioligand won on progression-free survival.","summary":"COMPETE, trial NCT03049189 sponsored by ITM Isotope Technologies Munich and published in the Lancet in 2025, was the first head-to-head trial of a radioligand against a targeted tablet in neuroendocrine tumours, and the radioligand won on progression-free survival. It randomised 309 patients with progressive grade 1 to 2 somatostatin-receptor-positive gastroenteropancreatic tumours to 177Lu-edotreotide or everolimus, met its primary progression-free survival endpoint with a significantly higher response rate, and showed an interim overall survival trend that was not significant; the result supports an FDA filing with a PDUFA date of 28 August 2026. Nuclide links it to peptide receptor radionuclide therapy, somatostatin receptor 2, 177Lu-edotreotide, everolimus and Jonathan R. Strosberg. Whether a second lutetium agent differentiates from lutetium dotatate is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03049189","url":"https://clinicaltrials.gov/study/NCT03049189"},{"label":"CancerNetwork: COMPETE","url":"https://www.cancernetwork.com/view/itm-11-demonstrates-superior-pfs-vs-everolimus-in-sstr-gep-nets"}],"tags":[],"related":["lu-177"],"indications":["neuroendocrine","pancreatic-net","small-intestinal-net"],"sections":[],"technologies":["prrt"],"targets":["sstr2"],"drugs":["itm-11","everolimus"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jonathan-strosberg"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03049189","phase":"3","setting":"Progressive grade 1-2 SSTR-positive GEP-NETs: 177Lu-edotreotide vs everolimus","sponsor":"ITM Isotope Technologies Munich","result":"PFS 23.9 vs 14.1 months, HR 0.67.","yearReported":2025,"enrolled":324,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"177Lu-edotreotide","n":207,"value":23.9},{"name":"Everolimus","n":102,"value":14.1}],"hr":0.67,"ci":[0.48,0.95],"p":"0.022","source":"https://doi.org/10.1016/S0140-6736(26)00604-5"},{"endpoint":"Overall survival (interim)","unit":"months","arms":[{"name":"177Lu-edotreotide","value":63.4},{"name":"Everolimus","value":58.7}],"hr":0.78,"ci":[0.5,1.1],"p":"0.206","source":"https://doi.org/10.1016/S0140-6736(26)00604-5"}]},"route":"/trials/compete/","neighbours":{"isotope":[{"id":"lu-177","kind":"isotope","name":"Lutetium-177","route":"/isotopes/lu-177/"}],"indication":[{"id":"grade-3-net","kind":"indication","name":"Grade 3 well-differentiated neuroendocrine tumour","route":"/indications/grade-3-net/"},{"id":"neuroendocrine","kind":"indication","name":"Neuroendocrine tumours","route":"/indications/neuroendocrine/"},{"id":"pancreatic-net","kind":"indication","name":"Pancreatic neuroendocrine tumours","route":"/indications/pancreatic-net/"},{"id":"small-intestinal-net","kind":"indication","name":"Small intestinal neuroendocrine tumours","route":"/indications/small-intestinal-net/"}],"technology":[{"id":"prrt","kind":"technology","name":"Peptide receptor radionuclide therapy (PRRT)","route":"/technologies/prrt/"}],"target":[{"id":"sstr2","kind":"target","name":"Somatostatin receptor 2","route":"/targets/sstr2/"}],"drug":[{"id":"itm-11","kind":"drug","name":"177Lu-edotreotide","route":"/drugs/itm-11/"},{"id":"everolimus","kind":"drug","name":"Everolimus","route":"/drugs/everolimus/"}],"person":[{"id":"jonathan-strosberg","kind":"person","name":"Jonathan R. Strosberg","route":"/people/jonathan-strosberg/"}]}}