{"entity":{"id":"netter-1","kind":"trial","name":"NETTER-1","aka":[],"tldr":"The trial that made radioligand therapy a standard: a radioactive drug homing to the somatostatin receptor held midgut neuroendocrine tumours in check far longer than high-dose octreotide, and it underpins Lutathera's approvals.","summary":"NETTER-1, trial NCT01578239 sponsored by Advanced Accelerator Applications and published in the New England Journal of Medicine in 2017, randomised 231 patients with inoperable, progressive, somatostatin receptor-positive midgut neuroendocrine tumours to 177Lu-Dotatate (four cycles, with octreotide) or high-dose octreotide LAR. Progression-free survival at 20 months was 65.2% with 177Lu-Dotatate against 10.8% with octreotide, and the response rate was 18% against 3%. The result supported the 2018 US and EU approvals of Lutathera and made peptide receptor radionuclide therapy the reference treatment after somatostatin analogues.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT01578239","url":"https://clinicaltrials.gov/study/NCT01578239"},{"label":"Strosberg et al., Phase 3 trial of 177Lu-Dotatate for midgut neuroendocrine tumours (NEJM 2017)","url":"https://doi.org/10.1056/NEJMoa1607427"}],"tags":[],"related":["lu-177"],"indications":["neuroendocrine","small-intestinal-net"],"sections":[],"technologies":["prrt"],"targets":["sstr2"],"drugs":["lutathera"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01578239","phase":"3","setting":"Inoperable, progressive midgut neuroendocrine tumours: 177Lu-Dotatate plus octreotide versus high-dose octreotide LAR","sponsor":"Advanced Accelerator Applications (Novartis)","result":"PFS at 20 months 65.2% vs 10.8% (HR 0.21); ORR 18% vs 3%.","yearReported":2017,"enrolled":231,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 20 months","primary":true,"unit":"%","arms":[{"name":"177Lu-Dotatate + octreotide","n":116,"value":65.2},{"name":"High-dose octreotide LAR","n":113,"value":10.8}],"hr":0.21,"ci":[0.13,0.33],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1607427"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"177Lu-Dotatate + octreotide","n":116,"value":18},{"name":"High-dose octreotide LAR","n":113,"value":3}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1607427"}]},"route":"/trials/netter-1/","neighbours":{"isotope":[{"id":"lu-177","kind":"isotope","name":"Lutetium-177","route":"/isotopes/lu-177/"}],"indication":[{"id":"neuroendocrine","kind":"indication","name":"Neuroendocrine tumours","route":"/indications/neuroendocrine/"},{"id":"pancreatic-net","kind":"indication","name":"Pancreatic neuroendocrine tumours","route":"/indications/pancreatic-net/"},{"id":"small-intestinal-net","kind":"indication","name":"Small intestinal neuroendocrine tumours","route":"/indications/small-intestinal-net/"}],"technology":[{"id":"prrt","kind":"technology","name":"Peptide receptor radionuclide therapy (PRRT)","route":"/technologies/prrt/"}],"target":[{"id":"sstr2","kind":"target","name":"Somatostatin receptor 2","route":"/targets/sstr2/"}],"drug":[{"id":"lutathera","kind":"drug","name":"Lutetium-177 dotatate","route":"/drugs/lutathera/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"paper":[{"id":"paper-strosberg-netter1-qol-jco-2018","kind":"paper","name":"Health-related quality of life in the NETTER-1 trial of 177Lu-Dotatate","route":"/key-papers/paper-strosberg-netter1-qol-jco-2018/"},{"id":"paper-netter-1-nejm-2017","kind":"paper","name":"NETTER-1: 177Lu-Dotatate for midgut neuroendocrine tumours progressing on octreotide","route":"/key-papers/paper-netter-1-nejm-2017/"}],"section":[{"id":"f-radioligand-therapy","kind":"section","name":"Radioligand therapy","route":"/fronts/f-radioligand-therapy/"}],"person":[{"id":"erik-mittra","kind":"person","name":"Erik S. Mittra","route":"/people/erik-mittra/"},{"id":"lisa-bodei","kind":"person","name":"Lisa Bodei","route":"/people/lisa-bodei/"}],"roadmap":[{"id":"dosimetry-roadmap","kind":"roadmap","name":"Dosimetry roadmap: MIRD schema → fixed dosing → personalised, image-based dose","route":"/roadmaps/dosimetry-roadmap/"},{"id":"sstr-theranostics-roadmap","kind":"roadmap","name":"SSTR theranostics roadmap: octreotide scintigraphy → 68Ga-DOTATATE → 177Lu-DOTATATE → alpha","route":"/roadmaps/sstr-theranostics-roadmap/"}],"term":[{"id":"krenning-score","kind":"term","name":"Krenning score","route":"/terms/krenning-score/"}]}}