{"entity":{"id":"nct03972488","kind":"trial","name":"Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET","aka":["NETTER-2"],"tldr":"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.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03972488","url":"https://clinicaltrials.gov/study/NCT03972488"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine","small-intestinal-net","pancreatic-net","grade-3-net"],"sections":[],"technologies":["radioligand-therapy"],"targets":[],"drugs":["lutathera"],"companies":["advanced-accelerator-applications"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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","started":"2020-01-08","startedType":"actual","yearReported":2024,"enrolled":226,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) Per Central Assessment","primary":true,"unit":"months","arms":[{"name":"Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm)","n":151,"value":22.8,"note":"95% CI 19.4 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-10-10), not from a publication"},{"name":"Octreotide LAR 60 mg (Control Arm)","n":75,"value":8.5,"note":"95% CI 7.7 to 13.8"}],"hr":0.276,"ci":[0.182,0.418],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT03972488?tab=results"},{"endpoint":"Overall Response Rate (ORR) Per Central Assessment (Key Secondary)","unit":"%","arms":[{"name":"Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm)","n":151,"value":43,"note":"95% CI 35.0 to 51.3; Figures from the ClinicalTrials.gov results section (first posted 2024-10-10), not from a publication"},{"name":"Octreotide LAR 60 mg (Control Arm)","n":75,"value":9.3,"note":"95% CI 3.8 to 18.3"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT03972488?tab=results"}]},"route":"/trials/nct03972488/","neighbours":{"cancer":[{"id":"grade-3-net","kind":"cancer","name":"Grade 3 well-differentiated neuroendocrine tumour","route":"/cancers/grade-3-net/"},{"id":"lung-net","kind":"cancer","name":"Lung neuroendocrine tumours (typical and atypical carcinoid)","route":"/cancers/lung-net/"},{"id":"neuroendocrine","kind":"cancer","name":"Neuroendocrine tumours","route":"/cancers/neuroendocrine/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"pancreatic-net","kind":"cancer","name":"Pancreatic neuroendocrine tumours","route":"/cancers/pancreatic-net/"},{"id":"small-intestinal-net","kind":"cancer","name":"Small intestinal neuroendocrine tumours","route":"/cancers/small-intestinal-net/"}],"technology":[{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"}],"drug":[{"id":"lutathera","kind":"drug","name":"Lutetium-177 dotatate","route":"/drugs/lutathera/"}],"company":[{"id":"advanced-accelerator-applications","kind":"company","name":"Advanced Accelerator Applications (Novartis)","route":"/companies/advanced-accelerator-applications/"}],"idea":[{"id":"idea-net-dosimetry-prrt","kind":"idea","name":"Dosimetry-personalised PRRT instead of four fixed cycles","route":"/ideas/idea-net-dosimetry-prrt/"}]}}