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Clinical trials for Lurbinectedin

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
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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).

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    14 result(s) found for: Lurbinectedin. Displaying page 1 of 1.
    EudraCT Number: 2021-004471-13 Sponsor Protocol Number: PM1183-C-008-21 Start Date*: 2022-08-03
    Sponsor Name:Pharma Mar, S.A.
    Full Title: A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination with Irinotecan versus Investigator’s Choice (Topotecan or Irinotecan) in Relaps...
    Medical condition: Small Cell Lung Cancer (SCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041067 Small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) BG (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned) AT (Trial now transitioned) DK (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001016-11 Sponsor Protocol Number: SAKK17/16 Start Date*: 2018-01-31
    Sponsor Name:SAKK
    Full Title: Lurbinectedin Monotherapy in Patients with Progressive Malignant Pleural Mesothelioma. A Multicenter, Single-arm Phase II Trial
    Medical condition: Pleural Mesothelioma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059518 Pleural mesothelioma malignant PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003602-16 Sponsor Protocol Number: PM1183-A-014-15 Start Date*: 2022-02-24
    Sponsor Name:Pharma Mar S.A.
    Full Title: Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin in Combination with Irinotecan in Pretreated Patients with Selected Advanced Solid Tumors.
    Medical condition: Selected Advanced Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IT (Trial now transitioned) DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-001930-20 Sponsor Protocol Number: GO43104 Start Date*: 2022-02-09
    Sponsor Name:F.Hoffmann-La Roche Ltd
    Full Title: A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF LURBINECTEDIN IN COMBINATION WITH ATEZOLIZUMAB COMPARED WITH ATEZOLIZUMAB AS MAINTENANCE THERAPY IN PARTICIPANTS WITH EXTENSIVE-STAGE SMALL...
    Medical condition: 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) ES (Ongoing) BE (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-001114-19 Sponsor Protocol Number: IB2022-01 Start Date*: 2023-04-03
    Sponsor Name:Institut Bergonié
    Full Title: Lurbinectedin combined with durvalumab (MEDI 4736) in pre-treated patients with extensive stage small-cell lung cancer
    Medical condition: platinum sensitive 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: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-000206-18 Sponsor Protocol Number: PM1183-B-005-14-QT Start Date*: 2015-09-10
    Sponsor Name:PharmaMar S.A., Sociedad Unipersonal
    Full Title: Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization (QTc Duration) in Patients with Selected Solid Tumors
    Medical condition: - small cell lung cancer (SCLC) - head and neck carcinoma (H&N) - neuroendocrine tumors (NETs) - biliary tract carcinoma - endometrial carcinoma - BRCA 1/2-associated metastatic breast carcinoma - ...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-003773-42 Sponsor Protocol Number: PM1183-B-005-14 Start Date*: 2015-03-30
    Sponsor Name:Pharma Mar S.A. Sociedad Unipersonal
    Full Title: A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors.
    Medical condition: Selected Advanced Solid Tumors.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed) SE (Completed) GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001641-89 Sponsor Protocol Number: PM1183-C-003-14 Start Date*: 2016-06-28
    Sponsor Name:Pharma Mar S.A.
    Full Title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin (DOX) versus Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR) (CAV) or Topotecan as Treatment in Patients w...
    Medical condition: Small-Cell Lung Cancer (SCLC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041067 Small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) AT (Completed) BE (Completed) ES (Completed) DE (Completed) GR (Completed) PT (Completed) CZ (Completed) NL (Completed) BG (Completed) GB (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-005251-39 Sponsor Protocol Number: PM1183-C-004-14 Start Date*: 2015-06-15
    Sponsor Name:Pharma Mar S.A., Sociedad Unipersonal
    Full Title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) versus Pegylated Liposomal Doxorubicin or Topotecan in Patients with Platinum-resistant Ovarian Cancer (CORAIL Trial)
    Medical condition: Platinum-resistant ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033130 Ovarian cancer NOS LLT
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Completed) ES (Completed) CZ (Completed) AT (Completed) BE (Completed) GB (Completed) FR (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002261-35 Sponsor Protocol Number: MedOPP300 Start Date*: 2020-03-03
    Sponsor Name:Dr.Antonio Calles Blanco
    Full Title: “Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Pembrolizumab in Patients with Relapsed Small Cell Lung Cancer (the LUPER stu...
    Medical condition: Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041067 Small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2013-000548-25 Sponsor Protocol Number: PM1183-B-004-13 Start Date*: 2013-06-11
    Sponsor Name:Pharma Mar S.A. Sociedad Unipersonal
    Full Title: A Randomized-Controlled Three-arm Phase II Study of Lurbinectedin (PM01183) Alone or In Combination with Gemcitabine and a control arm with Docetaxel as Second-Line Treatment in Unresectable Non-Sm...
    Medical condition: Unresectable Non-Small Cell Lung Cancer (NSCLC).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed) BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-001141-80 Sponsor Protocol Number: POLA/ACOG1401 Start Date*: 2015-07-27
    Sponsor Name:Andrés Poveda
    Full Title: Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 in combination with olaparib in patients with advanced solid tumors
    Medical condition: Advanced or metastatic solid tumors (Phase I) Patients with potential tumors with possibly sensitivity to PARP inhibitors according to histology, or patients with molecular features (Phase II)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-001553-12 Sponsor Protocol Number: 2SMALL Start Date*: 2019-11-28
    Sponsor Name:Fundacion ONCOSUR
    Full Title: Phase I-II Study to Assess the Safety, Tolerability and Efficacy of PM01183 and Atezolizumab in Patients with Advanced Small Cell Lung Cancer that Progressed Following Prior Therapy with Platinum-B...
    Medical condition: Histologically or cytologically confirmed diagnosis of extensive or limited SCLC. Progression to first-line platinum-based chemotherapy. Measurable disease according to RECIST v.1.1.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-024292-30 Sponsor Protocol Number: PM1183-B-001-10 Start Date*: 2011-09-05
    Sponsor Name:Pharma Mar, S.A. Sociedad Unipersonal
    Full Title: A Phase II Study of PM01183 as Second-line Treatment in Patients with Metastatic Pancreatic Cancer
    Medical condition: Metastatic Pancreatic Cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007109 Cancer of pancreas (excl head) metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
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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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