# 177Lu-edotreotide

Source: https://nuclide.cc/drugs/itm-11/  
Nuclide record `itm-11` (Agent). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

A second lutetium radioligand for neuroendocrine tumours that beat the standard pill everolimus in a head-to-head trial and is awaiting an FDA decision.

## Summary

COMPETE (Lancet 2025; 309 patients, grade 1-2 GEP-NETs): PFS 23.9 vs 14.1 months versus everolimus (HR 0.67); response rate higher; interim OS 63.4 vs 58.7 months, a difference that did not reach statistical significance (HR 0.78). Uses non-carrier-added 177Lu from ITM's own supply. NDA accepted with PDUFA 28 August 2026. COMPOSE (grade 2-3, versus CAPTEM/everolimus/FOLFOX) ongoing.

## Fields

- Kind: Agent
- Status: phase-3
- Last checked: 2026-09-07
- Code: ITM-11, n.c.a. 177Lu-DOTATOC
- Modality: Radioligand therapy (beta)
- Mechanism: DOTATOC peptide (SSTR2 agonist) chelating 177Lu; four cycles of 7.5 GBq every 3 months.
- Dosing: Intravenous; 7.5 GBq every 3 months × 4 with amino-acid renal protection

## Sources

- ClinicalTrials.gov NCT03049189 (COMPETE): https://clinicaltrials.gov/study/NCT03049189

## Connected records

- isotopes: [Lutetium-177](https://nuclide.cc/isotopes/lu-177/)
- indications: [Grade 3 well-differentiated neuroendocrine tumour](https://nuclide.cc/indications/grade-3-net/), [Neuroendocrine tumours](https://nuclide.cc/indications/neuroendocrine/), [Pancreatic neuroendocrine tumours](https://nuclide.cc/indications/pancreatic-net/), [Small intestinal neuroendocrine tumours](https://nuclide.cc/indications/small-intestinal-net/)
- technologies: [Peptide receptor radionuclide therapy (PRRT)](https://nuclide.cc/technologies/prrt/), [Radioligand therapy (beta emitters)](https://nuclide.cc/technologies/radioligand-therapy/)
- targets: [Somatostatin receptor 2](https://nuclide.cc/targets/sstr2/)
- companies: [ITM Isotope Technologies Munich](https://nuclide.cc/companies/itm/)
- trials: [COMPETE](https://nuclide.cc/trials/compete/), [Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE](https://nuclide.cc/trials/nct04919226/)
- pairings: [SSTR PET → PRRT](https://nuclide.cc/pairings/sstr-pet-to-prrt/)
- ideas: [Dosimetry-personalised PRRT instead of four fixed cycles](https://nuclide.cc/ideas/idea-net-dosimetry-prrt/)
- opportunities: [CAIX imaging of the indeterminate renal mass](https://nuclide.cc/opportunities/opp-caix-indeterminate-renal-mass/)
- drugs: [Gallium-68 edotreotide (DOTATOC)](https://nuclide.cc/drugs/ga-68-dotatoc/), [Lead-212 VMT-alpha-NET](https://nuclide.cc/drugs/pb-212-vmt-alpha-net/), [Lutetium-177 dotatate (radioligand equivalent)](https://nuclide.cc/drugs/lu-177-dotatate-generic/)
- bottlenecks: [Enriched target material for therapeutic isotopes](https://nuclide.cc/bottlenecks/b-enriched-target-material/)
- fronts: [Radioligand therapy](https://nuclide.cc/fronts/f-radioligand-therapy/)
- roadmaps: [SSTR theranostics roadmap: octreotide scintigraphy → 68Ga-DOTATATE → 177Lu-DOTATATE → alpha](https://nuclide.cc/roadmaps/sstr-theranostics-roadmap/)
- terms: [Fixed versus personalised (dosimetry-guided) dosing](https://nuclide.cc/terms/fixed-versus-personalised-dosing/), [Krenning score](https://nuclide.cc/terms/krenning-score/), [Renal protection with amino acid co-infusion](https://nuclide.cc/terms/renal-protection-amino-acids/)

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