COMPETE
The first head-to-head trial of a radioligand against a targeted pill in neuroendocrine tumours; the radioligand won on progression-free survival.
Overview
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.
- Median 23.9 vs 14.1 months with 177Lu-edotreotide compared with Everolimus; about 9.8 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 33 percent lower chance of the event at any given time (hazard ratio 0.67, likely range 0.48 to 0.95).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- Median 63.4 vs 58.7 months with 177Lu-edotreotide compared with Everolimus; about 4.7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 22 percent lower chance of the event at any given time (hazard ratio 0.78, likely range 0.5 to 1.1).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Progressive grade 1-2 SSTR-positive GEP-NETs: 177Lu-edotreotide vs everolimus. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (SSTR); the result should not be assumed for people whose cancer does not have it.
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.
Similar pages
not linked directly; found by shared links- AgentLutetium-177 dotatate (radioligand equivalent)
Shares 177Lu-edotreotide, Pancreatic neuroendocrine tumours, Small intestinal neuroendocrine tumours, Somatostatin receptor 2.
- TrialLutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
Shares Everolimus, Grade 3 well-differentiated neuroendocrine tumour, 177Lu-edotreotide, Pancreatic neuroendocrine tumours.
- IdeaSSTR antagonist radioligands to increase tumour dose
Shares Small intestinal neuroendocrine tumours, Somatostatin receptor 2, Peptide receptor radionuclide therapy (PRRT), Neuroendocrine tumours.
- CompanyMolecular Targeting Technologies
Shares Pancreatic neuroendocrine tumours, Small intestinal neuroendocrine tumours, Somatostatin receptor 2, Peptide receptor radionuclide therapy (PRRT).
- TrialRADIANT-3 and RADIANT-4
Shares Everolimus, Pancreatic neuroendocrine tumours, Small intestinal neuroendocrine tumours, Neuroendocrine tumours.
- TrialStudy to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
Shares Grade 3 well-differentiated neuroendocrine tumour, Pancreatic neuroendocrine tumours, Small intestinal neuroendocrine tumours, Neuroendocrine tumours.
- Key paperNETTER-2: lutetium-177 dotatate as first treatment for higher-grade gastroenteropancreatic neuroendocrine tumours
Shares Jonathan R. Strosberg, Grade 3 well-differentiated neuroendocrine tumour, Pancreatic neuroendocrine tumours, Small intestinal neuroendocrine tumours.
- PairingPRRT (177Lu-DOTATATE) with capecitabine and temozolomide (CAPTEM)
Shares Jonathan R. Strosberg, Pancreatic neuroendocrine tumours, Peptide receptor radionuclide therapy (PRRT), Neuroendocrine tumours.