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Clinical trials for Lutathera

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    12 result(s) found for: Lutathera. Displaying page 1 of 1.
    EudraCT Number: 2019-001562-15 Sponsor Protocol Number: CAAA601A22301 Start Date*: 2019-11-15
    Sponsor Name:Advanced Accelerator Applications SA
    Full Title: This is a multicenter, stratified, randomized, open-label comparator-controlled, Phase III study in patients with somatostatin receptor positive, well-differentiated G2 and G3, advanced GEP NETs, d...
    Medical condition: Patients with somatostatin receptor positive, well-differentiated G2 and G3, advanced GEP NETs
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052399 Neuroendocrine tumour PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077559 Gastroenteropancreatic neuroendocrine tumour disease PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077560 Gastroenteropancreatic neuroendocrine tumor disease LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) DE (Ongoing) NL (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002951-39 Sponsor Protocol Number: CAAA601A32201 Start Date*: Information not available in EudraCT
    Sponsor Name:Advanced Accelerator Applications SA
    Full Title: A multicenter open-label study to evaluate safety and dosimetry of Lutathera in adolescent patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheoc...
    Medical condition: somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomas
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052399 Neuroendocrine tumour PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077559 Gastroenteropancreatic neuroendocrine tumour disease PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077560 Gastroenteropancreatic neuroendocrine tumor disease LLT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10034876 Pheochromocytoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073860 Paraganglioma LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) FR (Trial now transitioned) PT (Prematurely Ended) PL (Trial now transitioned) BE (Completed) IT (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-001306-30 Sponsor Protocol Number: PROICM2021-04REL Start Date*: 2021-09-13
    Sponsor Name:Institut Régional du Cancer de Montpellier
    Full Title: A prospective randomized phase II study to assess the schemas of retreatment with Lutathera® ([177Lu]Lu-DOTA-TATE) in patients with new progression of intestinal well-differentiated neuroendocrine ...
    Medical condition: Patients with new progression of intestinal well-differentiated neuroendocrine tumor.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10062476 Neuroendocrine tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004073-76 Sponsor Protocol Number: CAAA001A12401 Start Date*: 2020-10-12
    Sponsor Name:Advanced Accelerator Applications International SA
    Full Title: A multicenter, open-label post authorization safety study to evaluate the effect of LysaKare® infusion on serum potassium levels in GEP-NET patients eligible for Lutathera® treatment
    Medical condition: LysaKare® is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177 Lu) oxodotreotide in adults.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10038428 Renal disorder PT
    20.1 10022117 - Injury, poisoning and procedural complications 10029140 Nephritis radiation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-003023-38 Sponsor Protocol Number: CHUBX2017/47 Start Date*: 2019-12-20
    Sponsor Name:CHU de Bordeaux
    Full Title: Imaging with 68Ga-DOTA-peptides and peptide receptor radionuclide therapy with 177Lu-DOTA-peptides of gastroenteropancreatic neuroendocrine tumors: interest of intra-arterial hepatic infusion in pa...
    Medical condition: Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10077560 Gastroenteropancreatic neuroendocrine tumor disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002196-34 Sponsor Protocol Number: Neo.Lu.Pa.NET Start Date*: 2019-11-07
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: A Prospective Phase II Single-Arm Trial on Neoadjuvant Peptide Receptor Radionuclide Therapy with 177Lu-DOTATATE Followed by Surgery for resectable Pancreatic Neuroendocrine Tumors (Neo.Lu.Pa.NET)
    Medical condition: Resectable pancreatic neuroendocrine tumors
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10067518 Pancreatic neuroendocrine tumor LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004445-36 Sponsor Protocol Number: LuDO-N Start Date*: Information not available in EudraCT
    Sponsor Name:Karolinska University Hospital
    Full Title: A phase II trial of 177Lutetium-DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma.
    Medical condition: Primary refractory or relapsed high-risk neuroblastoma.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) DK (Trial now transitioned) NO (Trial now transitioned) LT (Trial now transitioned) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-005049-11 Sponsor Protocol Number: AAA-III-01 Start Date*: 2012-04-25
    Sponsor Name:Advanced Accelerator Applications
    Full Title: A multi-centre, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperabl...
    Medical condition: Patients with inoperable, progressive, OctreoScan® positive, well-differentiated neuroendocrine tumours of the small bowel (midgut carcinoid tumours), who are treated with 20 mg or 30 mg Octreotide...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062392 Carcinoid tumor of the small bowel LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052399 Neuroendocrine tumour PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Completed) IT (Completed) BE (Completed) PT (Completed) FR (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002974-29 Sponsor Protocol Number: HMH008 Start Date*: 2020-01-14
    Sponsor Name:Fundación de investigación de HM Hospitales
    Full Title: A phase II single arm trial evaluating the preliminary efficacy of the combination of 177Lu-DOTATATE and nivolumab in Grade 3 well-differentiated neuroendocrine tumours (NET) or poorly differentiat...
    Medical condition: Neuroendocrine neoplasms (Grade 3 well-differentiated neuroendocrine tumours (NET) or poorly differentiated neuroendocrine carcinomas (NEC))
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057270 Neuroendocrine carcinoma PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052399 Neuroendocrine tumour PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062476 Neuroendocrine tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002996-36 Sponsor Protocol Number: 15TETE04 Start Date*: 2021-06-23
    Sponsor Name:INSTITUT CLAUDIUS REGAUD
    Full Title: A Phase I Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTA0-Tyr3-Octreotate in Children with Refractory or Recurrent Neuroblastoma expressing som...
    Medical condition: Recurrent or refractory neuroblastoma.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066595 Neuroblastoma recurrent PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000369-54 Sponsor Protocol Number: 60725 Start Date*: 2018-06-27
    Sponsor Name:University Medical Center Utrecht
    Full Title: Intra-arterial Lutetium-177- dotatate for treatment of patients with neuroendocrine tumor liver metastases
    Medical condition: Patients with neuro-endocrine tumors with liver metastases with an indication for treatment with lutetium-177-dotatate
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004155-16 Sponsor Protocol Number: CAAA601A42101 Start Date*: 2022-06-07
    Sponsor Name:Novartis Pharma AG
    Full Title: A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination with Carboplatin, Etoposide ...
    Medical condition: Extensive-Stage Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041068 Small cell lung cancer extensive stage PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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