How many clinical trials are studying Lutetium Lu 177 Dotatate?

4 recruiting trials in our tracked data involve Lutetium Lu 177 Dotatate.

What conditions is Lutetium Lu 177 Dotatate being studied for?

In our tracked recruiting trials, Lutetium Lu 177 Dotatate is being studied in trials for Pancreatic cancer, Advanced Lung Neuroendocrine Tumor, Digestive System Neuroendocrine Tumor G1.

Lutetium Lu 177 Dotatate: clinical trials recruiting now

Q: Is Lutetium Lu 177 Dotatate FDA-approved?

Yes. According to the FDA drug label available through openFDA, Lutetium Lu 177 Dotatate is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Lutetium Lu 177 Dotatate appears in the FDA drug-label database. Marketed as Lutathera.

FDA-approved use

LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. LUTATHERA is a radiolabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

FDA label via openFDA

Phase breakdown

Phase 1 1 Phase 2 2 Phase 4 1

Conditions being studied

Condition	Trials
Pancreatic cancer	2
Advanced Lung Neuroendocrine Tumor	1
Digestive System Neuroendocrine Tumor G1	1
Digestive System Neuroendocrine Tumor G2	1
Functioning Lung Neuroendocrine Tumor	1
Locally Advanced Lung Neuroendocrine Neoplasm	1
Lung Neuroendocrine Neoplasm	1
Lung Neuroendocrine Tumor G1	1
Lung Neuroendocrine Tumor G2	1
Lung cancer	1
Metastatic Digestive System Neuroendocrine Neoplasm	1
Metastatic Lung Neuroendocrine Neoplasm	1
Metastatic Lung Neuroendocrine Tumor	1
Metastatic Malignant Neoplasm in the Liver	1
Metastatic Pancreatic Neuroendocrine Tumor	1

Recruiting trials involving Lutetium Lu 177 Dotatate

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors
NCT06016855 · Phase: Phase 4 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
NCT04665739 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 29 locations
Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
NCT05687123 · Phase: Phase 1 · Ages: 18 Years and older · Sex: All (male and female) · 10 locations
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
NCT05691465 · Phase: Phase 2 · Ages: 18 Years and older · Sex: Male · 13 locations

Common questions

Is Lutetium Lu 177 Dotatate FDA-approved?

Yes, marketed as Lutathera.

How many recruiting trials involve Lutetium Lu 177 Dotatate?

4 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.