# 177Lu-edotreotide

Source: https://onco.cc/drugs/itm-11/  
OnCo record `itm-11` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.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: Treatment
- 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

- cancers: [Grade 3 well-differentiated neuroendocrine tumour](https://onco.cc/cancers/grade-3-net/), [Neuroendocrine tumours](https://onco.cc/cancers/neuroendocrine/), [Pancreatic neuroendocrine tumours](https://onco.cc/cancers/pancreatic-net/), [Small intestinal neuroendocrine tumours](https://onco.cc/cancers/small-intestinal-net/)
- technologies: [Peptide receptor radionuclide therapy (PRRT)](https://onco.cc/technologies/prrt/), [Radioligand therapy (beta emitters)](https://onco.cc/technologies/radioligand-therapy/)
- targets: [Somatostatin receptor 2](https://onco.cc/targets/sstr2/)
- companies: [ITM Isotope Technologies Munich](https://onco.cc/companies/itm/)
- trials: [COMPETE](https://onco.cc/trials/compete/), [Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.](https://onco.cc/trials/nct05918302/), [Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE](https://onco.cc/trials/nct04919226/)
- pairings: [SSTR PET → PRRT](https://onco.cc/pairings/sstr-pet-to-prrt/)
- ideas: [Dosimetry-personalised PRRT instead of four fixed cycles](https://onco.cc/ideas/idea-net-dosimetry-prrt/)

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