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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.
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.