Phase III Study Comparing 177LuLu-DOTA-TATE Plus Octreotide LAR Versus Octreotide LAR Alone in Newly Diagnosed Grade 1 and 2 Advanced Gastroenteropancreatic Neuroendocrine Tumors with High Disease Burden

What this Trial Is About

This research aims to evaluate the effectiveness and safety of a combination treatment using 177LuLu-DOTA-TATE plus octreotide long-acting release LAR compared to octreotide LAR alone. It focuses on patients aged 12 and older who have newly diagnosed, somatostatin receptor positive SSTR, well-differentiated Grade 1 or Grade 2 Ki-67 <10% advanced gastroenteropancreatic neuroendocrine tumors GEP-NETs with a high burden of disease. The study is a randomized, open-label Phase III trial sponsored by Novartis Pharmaceuticals. Participants are randomly assigned to one of two treatment groups. One group receives 177LuLu-DOTA-TATE administered four times every eight weeks, combined with octreotide LAR given every eight weeks initially and then every four weeks. The other group receives octreotide LAR alone every four weeks. The study includes a screening phase to confirm eligibility, followed by the treatment phase, and then a follow-up phase to monitor outcomes. During the study, participants undergo regular assessments including imaging to evaluate tumor progression, laboratory tests to monitor organ function, and evaluations of symptoms and quality of life. The main outcome being measured is progression-free survival PFS assessed by a blinded independent review committee after approximately 33 months. Additional measures include overall survival, response rates, disease control, quality of life changes, pharmacokinetics, and safety evaluations. Participants are followed for up to five years to track long-term outcomes.

Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET