# Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET

Source: https://onco.cc/trials/nct03972488/  
OnCo record `nct03972488` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Lutetium-177 dotatate in pancreatic ductal adenocarcinoma, run by Advanced Accelerator Applications, active and no longer recruiting.

## Summary

Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET is a phase 3 interventional study registered as NCT03972488 by Advanced Accelerator Applications, with 226 participants enrolled, started 2020-01-08 and due to reach its primary completion in 2023-07-20. Interventions recorded: Lutathera, 30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot), 2.5% Lys-Arg sterile amino acid solution and High dose 60 mg octreotide long-acting repeatable. Results have been posted on the registry.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Also known as: NETTER-2
- Tags: pipeline; ctgov-ingest
- Registry id: NCT03972488
- Phase: 3
- Setting: A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
- Sponsor: Advanced Accelerator Applications
- Enrolled: 226
- Outcomes: Progression Free Survival (PFS) Per Central Assessment: Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) 22.8 months vs Octreotide LAR 60 mg (Control Arm) 8.5 months, HR 0.276; Overall Response Rate (ORR) Per Central Assessment (Key Secondary): Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) 43% vs Octreotide LAR 60 mg (Control Arm) 9.3%

## Sources

- ClinicalTrials.gov NCT03972488: https://clinicaltrials.gov/study/NCT03972488

## Connected records

- cancers: [Grade 3 well-differentiated neuroendocrine tumour](https://onco.cc/cancers/grade-3-net/), [Lung neuroendocrine tumours (typical and atypical carcinoid)](https://onco.cc/cancers/lung-net/), [Neuroendocrine tumours](https://onco.cc/cancers/neuroendocrine/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Pancreatic neuroendocrine tumours](https://onco.cc/cancers/pancreatic-net/), [Small intestinal neuroendocrine tumours](https://onco.cc/cancers/small-intestinal-net/)
- technologies: [Radioligand therapy (beta emitters)](https://onco.cc/technologies/radioligand-therapy/)
- drugs: [Lutetium-177 dotatate](https://onco.cc/drugs/lutathera/)
- companies: [Advanced Accelerator Applications (Novartis)](https://onco.cc/companies/advanced-accelerator-applications/)
- ideas: [Dosimetry-personalised PRRT instead of four fixed cycles](https://onco.cc/ideas/idea-net-dosimetry-prrt/)

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