Drugs / Lu-177 DOTATATE

Trials 3 · a red edge is where a trial was stopped

2018201920202021202220232024202520262027202820292030
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT04086485 Oct 2022 → Jul 2027 expected digestive system neuroendocrine neoplasm National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT06121271 Dec 2023 → Nov 2027 expected medullary thyroid gland carcinoma, pheochromocytoma-paraganglioma University College, London Not yet recruiting No outcome recorded
Phase 2 NCT03206060 Oct 2017 → Jan 2030 expected paraganglioma, pheochromocytoma National Cancer Institute (NCI) Recruiting No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT03629847 Background Dec 2012 → Dec 2018 neuroendocrine neoplasm King Faisal Specialist Hospital & Research Center Unknown No outcome recorded

Press releases naming this drug 4 releases

DateIssuerRelease
2023-09-25 Novartis Pharmaceuticals Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) novartis.com
2021-06-03 Novartis Pharmaceuticals Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera novartis.com
2018-10-19 Novartis Pharmaceuticals Novartis announces presentation of new Lutathera® NETTER-1 data at ESMO demonstrating significant improvement in PFS regardless of baseline liver tumor burden novartis.com
2018-06-07 Novartis Pharmaceuticals Novartis announces JCO publication of Lutathera® NETTER-1 data showing significantly longer time to deterioration of key quality of life measures in patients with progressive midgut NETs novartis.com

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as Lu-177 DOTATATE “The goal of this study is to assess the safety and efficacy of the combination of everolimus and the intravenous radiolabeled Lu-177 DOTATATE Therapy as a 1st line therapy in...” NCT03629847
3

NCT04086485

NCT03206060

NCT06121271

Known as 177Lu-DOTATATE “Lutetium 177 (177Lu) - DOTATATE is a form of peptide receptor radionuclide therapy (PRRT) utilized in the treatment of neuroendocrine tumors.” PMID 33551992 Jan 2021
1

“The radiopeptide 177Lu-DOTATATE will be administered as a slow intravenous infusion via a cannula into a vein in the arm.” NCT06121271

Known as [177Lu]Lu-DOTA-TATE “The study population included patients (≥18 years) enrolled in a phase 2 trial for treatment of somatostatin receptor (SSTR)-2+ inoperable/metastatic...” PMID 37886645 Oct 2023
Known as Lutathera “Lu-177-DOTATATE (Lutathera) is a SSTR-agonist agent which emits ionizing radiation that causes DNA damage to its target cells through both direct and indirect mechanisms.” NCT04086485
2

“Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma” NCT03206060

“Lu-177 DOTATATE (Lutathera®)” NCT06121271

Known as Lutetium 177 (177Lu) - DOTATATE Lutetium 177 (177Lu) - DOTATATE is a form of peptide receptor radionuclide therapy (PRRT) utilized in the treatment of neuroendocrine tumors.” PMID 33551992 Jan 2021
Modality Peptide “Lutetium 177 (177Lu) - DOTATATE is a form of peptide receptor radionuclide therapy (PRRT) utilized in the treatment of neuroendocrine tumors.” PMID 33551992 Jan 2021
Route Intravenous “Lu-177-DOTATATE is administered IV every 8 (+/- 2) weeks, for a total of 4 administrations.” NCT03206060
Target SSTR2 “Lu-177-DOTATATE is a somatostatin analog that predominantly recognizes SSTR2.” NCT03206060