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The first head-to-head trial of a radioligand against a targeted pill in neuroendocrine tumours; the radioligand won on progression-free survival.
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. OnCo 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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
324 enrolled.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares SSTR antagonist radioligands to increase tumour dose, 177Lu-edotreotide, ITM Isotope Technologies Munich, Dosimetry-personalised PRRT instead of four fixed cycles.
Shares Dosimetry-personalised PRRT instead of four fixed cycles, Peptide receptor radionuclide therapy (PRRT), Somatostatin receptor 2, Small intestinal neuroendocrine tumours.
Shares Dosimetry-personalised PRRT instead of four fixed cycles, Grade 3 well-differentiated neuroendocrine tumour, Small intestinal neuroendocrine tumours, Pancreatic neuroendocrine tumours.
Shares 177Lu-edotreotide, Peptide receptor radionuclide therapy (PRRT), Somatostatin receptor 2, Neuroendocrine tumours.
Shares Jonathan R. Strosberg, Grade 3 well-differentiated neuroendocrine tumour, Somatostatin receptor 2, Small intestinal neuroendocrine tumours.
Shares Grade 3 well-differentiated neuroendocrine tumour, Peptide receptor radionuclide therapy (PRRT), Somatostatin receptor 2, Small intestinal neuroendocrine tumours.
Shares Grade 3 well-differentiated neuroendocrine tumour, Small intestinal neuroendocrine tumours, Pancreatic neuroendocrine tumours, Neuroendocrine tumours.
Shares Peptide receptor radionuclide therapy (PRRT), Somatostatin receptor 2, Small intestinal neuroendocrine tumours, Pancreatic neuroendocrine tumours.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/