Lutetium Lu 177 dotatate clinical trials
Also written Lutathera and 177Lu-DOTATATE.
How each study uses lutetium Lu 177 dotatate is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Approvals
The first approval found in each region, with its record
- United States
- Not in FDA's approval records
- European Union
- Not in EMA's list of EU-wide authorisations
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
49 studies that test it; most in 2020 (9)
| Year | Studies |
|---|---|
| 2004 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 9 |
| 2021 | 4 |
| 2022 | 2 |
| 2023 | 8 |
| 2024 | 7 |
| 2025 | 3 |
| 2026 | 2 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 5 · Other 44
National Cancer Institute (NCI) (6) · Novartis Pharmaceuticals (2) · Advanced Accelerator Applications (2) · Jules Bordet Institute (2) · Fundación de investigación HM (2) · Alliance for Clinical Trials in Oncology (1) · NYU Langone Health (1) · Stanford University (1)
Often tested with
Tested in the same studies.
Pembrolizumab (2) · 64Cu-DOTATATE (2) · Olaparib (2) · Triapine (1) · Peposertib (1) · Capecitabine (1) · Temozolomide (1) · Lutetium-177 (1)
Related medicines
As reviewed, each with the page that says it.
- One of Radiopharmaceuticals source
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 11, 1 in phase 3
Studies that test lutetium Lu 177 dotatate, phase 3 first.
- Nov 2026A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETsPhase 3 · HTA Co., Ltd.
- Nov 2026Study of PRRT in Metastatic, WHO Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive SurgeryPhase 1 · Stanford University
- Dec 2026Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine TumorsPhase 1 · National Cancer Institute (NCI)
- Dec 2026Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine TumorsPhase 1 · National Cancer Institute (NCI)
- Apr 2027177Lu-DOTATATE for Recurrent MeningiomaPhase 2 · European Organisation for Research and Treatment of Cancer - EORTC
- May 2027Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine TumorsPhase 4 · Vanderbilt-Ingram Cancer Center
- Jun 2027Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine CellsPhase 2 · National Cancer Institute (NCI)
- Sep 2027Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the LiverEarly Phase 1 · Memorial Sloan Kettering Cancer Center
- Sep 2027Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation TherapyPhase 2 · Mayo Clinic
- Oct 2027Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors, the ComPareNET TrialPhase 2 · Alliance for Clinical Trials in Oncology
Studies
Open first, then newest update. How each study uses lutetium Lu 177 dotatate is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 49
- Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine CellsRecruitingPhase 2National Cancer Institute (NCI)NCT05691465Written as Lutetium Lu 177 Dotatate
- Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT TrialRecruitingPhase 2National Cancer Institute (NCI)NCT05773274Written as Lutetium Lu 177 Dotatate
- Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine TumorsRecruitingPhase 2National Cancer Institute (NCI)NCT04665739Written as Lutetium Lu 177 Dotatate
- 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk NeuroblastomaRecruitingPhase 2Jakob StenmanNCT04903899Written as 177Lu-DOTATATE
- TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETSNot yet recruitingPhase 3Tata Memorial HospitalNCT07910760Written as Lutetium Lu 177 Dotatate
- Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine TumorsRecruitingPhase 1National Cancer Institute (NCI)NCT05687123Written as Lutetium Lu 177 Dotatate
- Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation TherapyRecruitingPhase 2Mayo ClinicNCT04082520Written as Lutetium Lu 177 Dotatate
- Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell CancerRecruitingPhase 2Weill Medical College of Cornell UniversityNCT05583708Written as Lutetium Lu 177 dotatate
- Lutathera for Treatment of Recurrent or Progressive High-Grade CNS TumorsRecruitingPhase 1/2Nationwide Children's HospitalNCT05278208Written as LUTATHERA® (Lutetium Lu 177 dotatate)
- Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine TumorsRecruitingPhase 4Vanderbilt-Ingram Cancer CenterNCT06016855Written as Lutetium Lu 177 Dotatate
- 177Lu-DOTATATE for Recurrent MeningiomaRecruitingPhase 2European Organisation for Research and Treatment of Cancer - EORTCNCT06326190Written as 177Lu-DOTATATE
- 177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast CancerRecruitingPhase 2OHSU Knight Cancer InstituteNCT04529044Written as Lutetium Lu 177 Dotatate
- Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NETRecruitingPhase 2Institut du Cancer de Montpellier - Val d'AurelleNCT04954820Written as Lutathera
- Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).RecruitingPhase 1/2Fundación de investigación HMNCT06607692Written as Olaparib; 177Lu-DOTATATE
- Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.RecruitingPhase 1Emory UniversityNCT07150546Written as Lutetium Lu 177 Dotatate
- 177Lu-DOTATATE Modified Delivery Based on Individualized DosimetryRecruitingPhase 2University of IowaNCT06395402Written as Lutetium Lu 177 dotatate therapy
- A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETsRecruitingPhase 3HTA Co., Ltd.NCT07057622Written as 177Lu-DOTATATE injection
- Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed IndicationsNot yet recruitingPhase 2University College, LondonNCT06121271Written as Lu-177 DOTATATE (Lutathera®)
- Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine TumorsActive, not recruitingPhase 1National Cancer Institute (NCI)NCT04234568Written as Lutetium Lu 177 Dotatate
- Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine TumorsActive, not recruitingPhase 1National Cancer Institute (NCI)NCT04750954Written as Lutetium Lu 177 Dotatate
See all 49 studies that test lutetium Lu 177 dotatate →
Given beside what is tested · 5 — lutetium Lu 177 dotatate is usual care or a partner of the new treatment
- Study to Test the Combination of Fulvestrant With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine TumorsRecruitingPhase 1University of ChicagoNCT06663072Written as 177Lu-DOTATATE
- A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and AtezolizumabActive, not recruitingPhase 1/2Novartis PharmaceuticalsNCT05142696Written as [177Lu]Lu-DOTA-TATE
- Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine TumorsActive, not recruitingPhase 2National Cancer Institute (NCI)NCT05724108Written as Lutetium Lu 177 Dotatate
- Comparing 177Lu-Dotatate/Capecitabine Combination Treatment With 177Lu-Dotatate in Neuroendocrine Tumor PatientsTerminatedPhase 2Erasmus Medical CenterNCT07012330Written as 177Lu-DOTATATE
- A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine TumorsWithdrawnPhase 1/2David BushnellNCT04614766Written as Lutathera
What changed recently
From the registry's own updates since Oct 16, 2026.
Newly registered1
- TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETSNov 2, 2026NCT07910760
Codes
What other systems call lutetium Lu 177 dotatate · ClinicalTrials.gg INT004424
- MeSH (NLM) C447941lutetium Lu 177 dotatateConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) AE221IM3BBLUTETIUM OXODOTREOTIDE LU-177Confirmed FDA, NLM
- RxNorm 1999335One source FDA
- NCI Thesaurus C95020Lutetium Lu 177 DotatateOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C447941 | lutetium Lu 177 dotatate | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | AE221IM3BB | LUTETIUM OXODOTREOTIDE LU-177 | Confirmed FDA, NLM |
| RxNorm | 1999335 | — | One source FDA |
| NCI Thesaurus | C95020 | Lutetium Lu 177 Dotatate | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.