Clinical trialPhase 3Active not recruiting
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)
- Outcome
- Ongoing
- Phase
- Phase 3
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 2 February 2017
- Expected end
- November 2029
- Enrollment
- 324 participants
- Sites
- 52
- Primary outcomes
- Progression-Free Survival (PFS)
- Sponsor
- Industry
- Results posted
- 2026-04-06
- Last update
- 20 October 2026
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Brief summary public domain (ClinicalTrials.gov)
The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression-Free Survival (PFS) [From date of randomization until the date of first documented progression or death, assessed up to 30 months,]. Median, Months (95% Confidence Interval). 177Lu-edotreotide PRRT (n=207): 23.9 (18.7 to 30.0); Everolimus (n=102): 14.1 (9.2 to 20.9). Analysis, 177Lu-edotreotide PRRT vs Everolimus: Hazard Ratio (HR) 0.673 (95% CI 0.477 to 0.948); p=0.0223; Log Rank; superiority.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (ORR) [Up to 30 months]. Number, Percentage of participants (95% Confidence Interval). 177Lu-edotreotide PRRT (n=201): 21.9 (16.2 to 27.6); Everolimus (n=95): 4.2 (0.2 to 8.2). Analysis, 177Lu-edotreotide PRRT vs Everolimus: p=<0.0001; Mantel Haenszel; superiority.
Papers 1
- Registry-listed results paper[177Lu]Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multice… DOI 10.1016/s0140-6736(26)00604-5↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.