Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Lutathera clinical trials

Also listed in trial records as AAA601, Lu 177 dotatate
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 11 trials in our France, Spain, USA, UK, Canada, Germany, South Korea, Portugal, Austria, Switzerland, Italy, Netherlands, Poland, China, Czechia, Singapore, Israel, Norway and Mexico registers that name Lutathera as an intervention. Synced 10 Nov 2026
11Current trials
6Recruiting now
7Lead sponsors
19Country registers
At a glance

Lutathera is named as an intervention in 11 current clinical trials in our France, Spain, USA, UK, Canada, Germany, South Korea, Portugal, Austria, Switzerland, Italy, Netherlands, Poland, China, Czechia, Singapore, Israel, Norway and Mexico registers. 6 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Advanced Accelerator Applications (3). The most-studied condition is Neuroendocrine Tumors.

Patient leaflets for Lutathera

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting655%
  • Active, closed545%

Trials by phase

  • Phase 2436%
  • Phase 3218%
  • Observational218%
  • Phase 1218%
  • Phase 1/219%
01

Clinical trials of Lutathera

11 trials
StudyPhaseStatusLead sponsorRegisters
Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors
NCT06878664 · ClinicalTrials.gov ↗ · Grade1-2 Advanced Midgut Neuroendocrine Tumors (NETs)
Phase 3 Recruiting Grupo Espanol de Tumores Neuroendocrinos France, Spain
Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
NCT04954820 · ClinicalTrials.gov ↗ · Neuroendocrine Tumors, Intestinal Well Differentiated Endocrine Tumor, Progressive Disease
Phase 2 Recruiting Institut du Cancer de Montpellier - Val d'Aurelle France
Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial
NCT05773274 · ClinicalTrials.gov ↗ · Metastatic Digestive System Neuroendocrine Tumor G1, Metastatic Digestive System Neuroendocrine Tumor G2, Unresectable Digestive System Neuroendocrine Tumor G1
Phase 2 Recruiting National Cancer Institute (NCI) Canada, Mexico
177Lu-DOTATATE for Recurrent Meningioma
NCT06326190 · ClinicalTrials.gov ↗ · Recurrent Meningioma
Phase 2 Recruiting European Organisation for Research and Treatment of Cancer - EORTC Germany, France, Spain, Switzerland, Austria, Norway
Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
NCT05687123 · ClinicalTrials.gov ↗ · Metastatic Pancreatic Neuroendocrine Tumor, Pancreatic Neoplasm, Stage III Pancreatic Neuroendocrine Tumor AJCC v8
Phase 1 Recruiting National Cancer Institute (NCI) Canada
Spanish Series of Patients Treated With the Radionuclide Lutetium177
NCT04949282 · ClinicalTrials.gov ↗ · Neuroendocrine Tumors, Intestinal Neoplasms, Pancreatic Neoplasms
Observational Recruiting Sociedad Española de Medicina Nuclear e Imagen Molecular Spain
Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
NCT03972488 · Gastro-enteropancreatic Neuroendocrine Tumor
Phase 3 Active, closed Advanced Accelerator Applications UK, USA, Germany, France, Spain, Italy, Netherlands, Canada, South Korea
Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs
NCT04711135 · Gastroenteropancreatic Neuroendocrine Tumors, Pheochromocytoma, Paraganglioma
Phase 2 Active, closed Advanced Accelerator Applications UK, USA, France, Spain, Poland
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
NCT05142696 · Extensive Stage Small Cell Lung Cancer
Phase 1/2 Active, closed Novartis Pharmaceuticals UK, USA, China, Germany, France, Spain, Austria, Czechia, Canada, South Korea, Singapore, Israel
A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent.
NCT05109728 · Glioblastoma
Phase 1 Active, closed Novartis Pharmaceuticals USA, France, Spain, Switzerland, Portugal
Post-Authorization Long-Term Safety Study of LUTATHERA
NCT03691064 · Neuroendocrine Tumors
Observational Active, closed Advanced Accelerator Applications UK, USA, France, Spain, Portugal

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Lutathera

22 conditions
Neuroendocrine Tumors3Gastro-enteropancreatic Neuroendocrine Tumor1Gastroenteropancreatic Neuroendocrine Tumors1Pheochromocytoma1Paraganglioma1Extensive Stage Small Cell Lung Cancer1Glioblastoma1Recurrent Meningioma1Grade1-2 Advanced Midgut Neuroendocrine Tumors (NETs)1Intestinal Well Differentiated Endocrine Tumor1Progressive Disease1Intestinal Neoplasms1
All 22 conditions
Condition (as registered)Trials
Neuroendocrine Tumors3
Gastro-enteropancreatic Neuroendocrine Tumor1
Gastroenteropancreatic Neuroendocrine Tumors1
Pheochromocytoma1
Paraganglioma1
Extensive Stage Small Cell Lung Cancer1
Glioblastoma1
Recurrent Meningioma1
Grade1-2 Advanced Midgut Neuroendocrine Tumors (NETs)1
Intestinal Well Differentiated Endocrine Tumor1
Progressive Disease1
Intestinal Neoplasms1
Pancreatic Neoplasms1
Stomach Neoplasms1
Metastatic Digestive System Neuroendocrine Tumor G11
Metastatic Digestive System Neuroendocrine Tumor G21
Unresectable Digestive System Neuroendocrine Tumor G11
Unresectable Digestive System Neuroendocrine Tumor G21
Metastatic Pancreatic Neuroendocrine Tumor1
Pancreatic Neoplasm1
Stage III Pancreatic Neuroendocrine Tumor AJCC v81
Stage IV Pancreatic Neuroendocrine Tumor AJCC v81
05

Related compounds

06

Questions about Lutathera trials

How many clinical trials are testing Lutathera?

11 current trials in our France, Spain, USA, UK, Canada, Germany, South Korea, Portugal, Austria, Switzerland, Italy, Netherlands, Poland, China, Czechia, Singapore, Israel, Norway and Mexico registers name Lutathera (also registered as AAA601) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Lutathera trials recruiting patients?

Yes. 6 of the 11 trials are recruiting: 3 with sites in France, 3 with sites in Spain, 2 with sites in Canada, 1 with sites in Germany, 1 with sites in Austria, 1 with sites in Switzerland, 1 with sites in Norway and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Lutathera clinical trials?

Advanced Accelerator Applications (3), Novartis Pharmaceuticals (2), National Cancer Institute (NCI) (2) and European Organisation for Research and Treatment of Cancer - EORTC (1), among 7 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Lutathera works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Lutathera works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Lutathera (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.