About this trial
This study looks at how well a treatment called [177Lu]Lu-DOTA-TATE works when added to octreotide long-acting release (LAR) compared to using octreotide LAR alone. It is for patients who have just been diagnosed with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET) that are well differentiated and have a high disease burden. The goal is to see if the combination treatment can help control the cancer better than octreotide LAR by itself.
The trial's ID number is NCT06784752. It is a Phase 3 study, meaning it is looking at how well this treatment works and how safe it is. It is regulated by the FDA, and the trial hopes to include around 240 participants.
Who can join
The trial is open to men and women aged 12 to 100 years. To participate, you must have a specific type of neuroendocrine tumor that has been diagnosed within the last 6 months and show signs of high disease burden. Some medical conditions may prevent you from joining. The trial team will check to see if you meet the requirements to participate.
Conditions
Somatostatin Receptor Positive (SSTR+), Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into one of two groups. One group will receive [177Lu]Lu-DOTA-TATE along with octreotide LAR. The other group will receive only octreotide LAR. The treatment will happen over several visits, with [177Lu]Lu-DOTA-TATE given every 8 weeks.
Where
This trial is running at 19 locations in the United States. 18 of them are currently recruiting.
Blue Ridge Cancer Center
Wytheville, Virginia
Hartford Hospital
Hartford, Connecticut
Henry Ford Hospital
Detroit, Michigan
Highlands Oncology Group
Fayetteville, Arkansas
LSU Medical Center
New Orleans, Louisiana
Mayo Clinic Arizona
Scottsdale, Arizona
Mayo Clinic Jacksonville
Jacksonville, Florida
Mount Sinai Medical Center
New York, New York
The first 8 of 19 sites are listed here. The registry record has the full list.