OncoMatch/Clinical Trials/Lutathera

Lutathera (177Lu-DOTATATE) Clinical Trials

Lutathera (lutetium Lu 177 dotatate, 177Lu-DOTATATE) is a peptide receptor radionuclide therapy (PRRT) — a radioligand that binds the somatostatin receptor (SSTR2) overexpressed on neuroendocrine tumor cells and delivers targeted beta-particle radiation directly to the tumor. It was FDA-approved in January 2018 for somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults, based on the Phase 3 NETTER-1 trial, which showed a marked progression-free survival benefit over high-dose octreotide; FDA expanded the approval in April 2024 to pediatric patients 12 years and older. Eligibility requires somatostatin-receptor positivity, established by 68Ga-DOTATATE PET (or an equivalent SSTR imaging scan). The NETTER-2 trial subsequently showed first-line progression-free survival benefit for 177Lu-DOTATATE plus octreotide LAR in newly diagnosed, higher-proliferation grade 2-3 advanced GEP-NETs, and active trials are evaluating earlier-line use, lung and other SSTR-positive NETs, combinations, and next-generation alpha-emitter analogues such as actinium-225 DOTATATE.