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NCT06784752 · ClinicalTrials.gov registry record · Phase 3
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 3 study of Somatostatin Receptor Positive (SSTR+) and Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET), sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT06784752: Recruiting Phase 3 study of Somatostatin Receptor Positive (SSTR+) and Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET), sponsored by Novartis Pharmaceuticals.
NCT06784752 is a Phase 3 study of Somatostatin Receptor Positive (SSTR+) and Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06784752, a Phase 3 study of Somatostatin Receptor Positive (SSTR+) and Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
PFS is defined as the time from randomization to the first occurrence of progression (centrally assessed by Blinded Independent Review Committee (BIRC) according to RECIST v1.1) or death due to any cause.
Conditions Studied
Interventions
- RADIATION [177Lu]Lu-DOTA-TATE
- DRUG Octreotide LAR
Study Locations (20)
Virginia
- Virginia Cancer Specialists - Fairfax
- Virginia Oncology Associates - Norfolk
- Blue Ridge Cancer Center - Wytheville
Connecticut
- Hartford Hospital - Hartford
- Yale New Haven Hospital - New Haven
Texas
- TxO Austin Midtown - Austin
- Texas Oncology - Dallas
Ontario
- Novartis Investigative Site - London
- Novartis Investigative Site - Toronto
Arizona
- Mayo Clinic Arizona - Scottsdale
Arkansas
- Highlands Oncology Group - Fayetteville
Colorado
- Rocky Mountain Cancer Centers - Denver
Florida
- Mayo Clinic Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2025-05-30 |
| Est. Completion | 2034-01-05 |
| Phase | Phase 3 |
What NCT06784752 shows while recruiting
NCT06784752 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Somatostatin Receptor Positive (SSTR+) appearing as the primary indexed condition, and to 2 interventions - of which [177Lu]Lu-DOTA-TATE is the first listed.
NCT06784752 names 20 study sites across 15 states, led by Virginia, Connecticut, Texas.
Frequently Asked Questions
What is clinical trial NCT06784752 about?
NCT06784752 is a clinical study titled "Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET". 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 \<...
What is the current status of trial NCT06784752?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2025-05-30. Estimated completion is 2034-01-05.
What conditions does trial NCT06784752 study?
This clinical trial studies the following conditions: Somatostatin Receptor Positive (SSTR+), Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET).
What interventions are being tested in trial NCT06784752?
The interventions under investigation include: [177Lu]Lu-DOTA-TATE (RADIATION), Octreotide LAR (DRUG).
Who is sponsoring clinical trial NCT06784752?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06784752 being conducted?
This trial has 20 study locations across Arizona, Arkansas, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06784752's enrollment target sits among peer trials
240 1274th of 2000 higher than 710 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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