Study detail
RecruitingPhase 3
A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients Newly Diagnosed With Grade 1 and Grade 2 (Ki-67 <10%) Advanced GEP-NET With High Disease Burden (NETTER-3)
Novartis Pharmaceuticals
Summary
The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with high disease burden
Description
The study consists of a screening phase, a treatment phase and a follow-up phase. This study compares treatment with \[177Lu\]Lu-DOTA-TATE plus octreotide LAR and octreotide LAR only.
Eligibility
- Age range
- 12–100 years
- Sex