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Lutathera

DRUG12 trials

Sponsors

Advanced Accelerator Applications, NYU Langone Health, King's College Hospital NHS Trust, Stanford University, David Bushnell

Conditions

Carcinoid Heart DiseaseCarcinoid SyndromeCarcinoid TumorGastro-enteropancreatic Neuroendocrine TumorGastroenteropancreatic Neuroendocrine NeoplasmGastroenteropancreatic Neuroendocrine TumorIntestinal Well Differentiated Endocrine TumorLiver Metastases

Phase 1

Study of PRRT in Metastatic, WHO Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
Active, not recruitingNCT04609592
Stanford UniversityGastroenteropancreatic Neuroendocrine Tumor
Start: 2021-03-17End: 2027-05-01Updated: 2026-08-12
A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors
WithdrawnNCT04614766
David BushnellGastro-enteropancreatic Neuroendocrine Tumor, Neuroendocrine Tumors
Start: 2022-09-30End: 2024-04-23Updated: 2024-04-29
Lutathera and ASTX727 in Neuroendocrine Tumours
RecruitingNCT05178693
Imperial College LondonNeuroendocrine Tumors
Start: 2022-04-25End: 2029-02-28Target: 27Updated: 2025-11-24

Phase 2

Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma
Active, not recruitingNCT03971461
NYU Langone HealthMeningioma
Start: 2019-05-15End: 2027-01-01Updated: 2026-03-11
Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy
NCT04039516
King's College Hospital NHS TrustCarcinoid Heart Disease, Carcinoid Syndrome, Carcinoid Tumor
Start: 2020-10-31End: 2024-12-31Target: 20Updated: 2020-08-04
Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
RecruitingNCT04954820
Institut du Cancer de Montpellier - Val d'AurelleIntestinal Well Differentiated Endocrine Tumor, Neuroendocrine Tumors, Progressive Disease
Start: 2021-10-18End: 2033-10-01Target: 146Updated: 2026-06-04
Comparison of Adjuvant Treatment With 177Lu-DOTATATE to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases
TerminatedNCT05987176
Imperial College LondonGastroenteropancreatic Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Tumor, Liver Metastases +3
Start: 2024-08-02End: 2025-10-21Updated: 2026-01-14

Phase 3

Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
Active, not recruitingNCT03972488
Advanced Accelerator ApplicationsGastro-enteropancreatic Neuroendocrine Tumor
Start: 2020-01-08End: 2027-10-29Updated: 2026-01-21

Unknown Phase

Post-Authorization Long-Term Safety Study of LUTATHERA
Active, not recruitingNCT03691064
Advanced Accelerator ApplicationsNeuroendocrine Tumors
Start: 2018-11-28End: 2027-09-30Updated: 2025-12-23
A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea
CompletedNCT04946305
Novartis PharmaceuticalsSomatostatin Receptor-positive GEP-NET
Start: 2022-05-10End: 2024-07-08Updated: 2024-08-09
Biomarker Identification of Radionuclide Therapy-induced Radiation Responses
NCT05513469
Erasmus Medical CenterNeuroendocrine Tumors
Start: 2023-01-01End: 2024-10-01Target: 20Updated: 2023-04-07
LUTATHERA Injection General Use Result Survey
CompletedNCT05844332
Novartis PharmaceuticalsSomatostatin Receptor-positive Neuroendocrine Tumor
Start: 2021-12-17End: 2024-06-27Updated: 2025-12-22

Related Papers

Final results of a single-arm, open-label, multicenter phase 2 study of the radiopharmaceutical [ <sup>177</sup> Lu]Lu-DOTA-TATE and [ <sup>68</sup> Ga]Ga-DOTA-TATE in adults with advanced intracranial meningioma.
Journal of Clinical Oncology2026-05-27
IMG-72. [68Ga]Ga-DOTA-TATE PET as imaging biomarker for response assessment and monitoring in patients receiving [177Lu]Lu-DOTA-TATE for advanced intracranial meningioma
Neuro-Oncology2025-11-01
CTNI-41. RESULTS OF A SINGLE-ARM, OPEN-LABEL, MULTICENTER PHASE 2 STUDY OF THE RADIOPHARMACEUTICAL [177LU]LU-DOTA-TATE IN ADULTS WITH ADVANCED INTRACRANIAL MENINGIOMA
Neuro-Oncology2025-11-01
A multi-centre, stratified, open, randomized, comparator-controlled, parallel group phase II trial comparing adjuvant treatment with 177Lu-DOTATATE to standard of care in patients after resection of neuroendocrine liver metastases (NELMAS).
Journal of Clinical Oncology2025-05-28
[<sup>177</sup>Lu]Lu-DOTA-TATE plus long-acting octreotide versus high‑dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2-3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study.
2024-06-05184 citations
Safety and time to response of [<sup>177</sup>Lu]Lu-DOTATATE in patients with newly diagnosed advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Sub-analysis of the phase 3 randomized NETTER-2 study.
Journal of Clinical Oncology2024-06-011 citations
[<sup>177</sup>Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Primary analysis of the phase 3 randomized NETTER-2 study.
Journal of Clinical Oncology2024-01-2045 citations
Evaluation of the SSTR2-targeted Radiopharmaceutical 177Lu-DOTATATE and SSTR2-specific 68Ga-DOTATATE PET as Imaging Biomarker in Patients with Intracranial Meningioma
Clinical Cancer Research2023-12-0437 citations
Study protocol of LANTana: a phase Ib study to investigate epigenetic modification of somatostatin receptor-2 with ASTX727 to improve therapeutic outcome with [177Lu]Lu-DOTA-TATE in patients with metastatic neuroendocrine tumours, UK
BMJ Open2023-10-015 citations
LANTana trial protocol: An open label, single arm, phase Ib study to evaluate the effect of pre-treatment with ASTX727 (a demethylating agent) followed by lutetium Lu 177 dotatate in patients with progressive, metastatic neuroendocrine neoplasias (NENs).
Journal of Clinical Oncology2023-06-01
Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study
European Journal of Nuclear Medicine and Molecular Imaging2023-03-0650 citations
A prospective, randomized, phase II study to assess the schemas of retreatment with Lutathera® in patients with new progression of an intestinal, well-differentiated neuroendocrine tumor (ReLUTH).
2022-12-2211 citations
CTNI-57. RADIONUCLIDE THERAPY WITH 177LU-DOTATATE (LUTATHERA) IN ADULTS WITH ADVANCED INTRACRANIAL MENINGIOMA - INTERIM ANALYSIS RESULTS OF A SINGLE-ARM, OPEN-LABEL, MULTICENTER PHASE II STUDY
Neuro-Oncology2022-11-012 citations
CTNI-53. SINGLE ARM, OPEN-LABEL, MULTICENTER PHASE II STUDY OF THE RADIONUCLIDE 177LU-DOTATATE (LUTATHERA) IN ADULTS WITH ADVANCED INTRACRANIAL MENINGIOMA
Neuro-Oncology2020-11-011 citations