Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06784752

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

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)

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
240 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Sex
All
Age
12 Years – 100 Years
Healthy volunteers
Not accepted

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
RADIATION[177Lu]Lu-DOTA-TATE\[177Lu\]Lu-DOTA-TATE will be administered 4 times during treatment period with frequency of every 8 weeks (Q8W)
DRUGOctreotide LAROctreotide LAR will be administered Q8W when co-administered with \[177Lu\]Lu-DOTA-TATE in the investigational arm followed by Q4W. In the control arm Octreotide LAR will be administered Q4W.

Timeline

Start date
2025-05-30
Primary completion
2028-12-08
Completion
2034-01-23
First posted
2025-01-20
Last updated
2026-04-16

Locations

66 sites across 12 countries: United States, Canada, China, France, Germany, Hungary, Italy, Netherlands, Poland, South Korea, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT06784752. Inclusion in this directory is not an endorsement.