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Clinical trials for Lorlatinib

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    13 result(s) found for: Lorlatinib. Displaying page 1 of 1.
    EudraCT Number: 2017-000640-18 Sponsor Protocol Number: NANT2015-02 Start Date*: 2018-08-13
    Sponsor Name:NANT Operations Centre
    Full Title: NANT 2015-02: PHASE 1 STUDY OF LORLATANIB (PF-06463922), AN ORAL SMALL MOLECULE INHIBITOR OF ALK/ROS1, FOR PATIENTS WITH RELAPSED OR REFRACTORY NEUROBLASTOMA
    Medical condition: Relapsed or refractory high risk neuroblastoma
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-003862-41 Sponsor Protocol Number: EORTC1825LCG Start Date*: 2020-06-30
    Sponsor Name:European Organisation for Research and Treatment of Cancer
    Full Title: Activity of Lorlatinib based on ALK resistance mutations on blood in ALK positive NSCLC patients previously treated with 2nd generation ALK inhibitor
    Medical condition: Non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 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: NO (Completed) NL (Completed) FR (Completed) IT (Prematurely Ended) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002230-37 Sponsor Protocol Number: IFCT-1902 Start Date*: 2019-09-16
    Sponsor Name:IFCT
    Full Title: A phase II non-randomized, single group assignment, open-label, multicenter study of efficacy and safety of lORlatinib (PF-06463922) monotherapy after failure of first-line second-generation ALK ki...
    Medical condition: advanced ALK-positive non-small cell Lung cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005569-42 Sponsor Protocol Number: B7461039 Start Date*: 2022-02-01
    Sponsor Name:Pfizer Inc.
    Full Title: LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM P...
    Medical condition: ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003970-41 Sponsor Protocol Number: CRU3 Start Date*: 2017-07-06
    Sponsor Name:UNIVERSITÀ DEGLI STUDI MILANO BICOCCA
    Full Title: A PHASE 2 OPEN LABEL STUDY OF ORAL LORLATINIB (PF-06463922) IN PATIENTS WITH RELAPSED ALK POSITIVE LYMPHOMA PREVIOUSLY TREATED WITH ALK INHIBITORS
    Medical condition: Anaplastic Large Cells Lymphoma (ALCL) ALK+
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073478 Anaplastic large-cell lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004466-19 Sponsor Protocol Number: IFCT-2003 Start Date*: 2021-01-07
    Sponsor Name:IFCT
    Full Title: A phase II single-group assignment, multicenter study of efficacy and safety of lorlatinib monotherapy after failure of first-line tyrosine kinase inhibitor in patients with advanced ROS1-positive ...
    Medical condition: advanced ROS1-positive non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002504-41 Sponsor Protocol Number: B7461027 Start Date*: 2020-07-17
    Sponsor Name:Pfizer Inc.
    Full Title: Single-Arm Study of Lorlatinib in Participants with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) Whose Disease Progressed After One Prior Second-Generation ALK Tyros...
    Medical condition: ALK-positive metastatic non-small-cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 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: PL (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003315-35 Sponsor Protocol Number: B7461006 Start Date*: 2017-08-01
    Sponsor Name:Pfizer Inc,
    Full Title: A Phase 3, randomized, open-label study of lorlatinib (PF-06463922) monotherapy versus crizotinib monotherapy in the first-line treatment of patients with advanced ALK-positive non-small cell lung ...
    Medical condition: Advanced ALK positive non small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) DK (Prematurely Ended) CZ (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-002620-17 Sponsor Protocol Number: B7461001 Start Date*: 2014-03-21
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: Phase 1/2 study of PF-06463922 (an ALK/ROS1 tyrosine kinase inhibitor) in patients with advanced non-small cell lung cancer harboring specific molecular alterations.
    Medical condition: Anaplastic Lymphoma Kinase (ALK)-positive (ALK+) or ROS oncogene 1 (ROS1)-positive (ROS1+) advanced 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) 10029522 Non-small cell lung cancer stage IV PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066490 Progression of non-small cell lung cancer LLT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-003616-13 Sponsor Protocol Number: TPX-0005-01 Start Date*: 2020-05-12
    Sponsor Name:Turning Point Therapeutics, Inc.
    Full Title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ...
    Medical condition: advanced solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) DE (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) HU (Trial now transitioned) DK (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000122-21 Sponsor Protocol Number: NVL-655-01 Start Date*: 2022-07-08
    Sponsor Name:Nuvalent, Inc.
    Full Title: A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
    Medical condition: Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors with ALK rearrangement or activating ALK mutation.
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003296-19 Sponsor Protocol Number: AFM24-101 Start Date*: 2020-03-27
    Sponsor Name:Affimed GmbH
    Full Title: A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients with Advanced Solid Cancers
    Medical condition: Advanced solid malignancies in patients whose disease has progressed after treatment with previous anticancer therapies.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002457-29 Sponsor Protocol Number: B9991046 Start Date*: 2021-12-23
    Sponsor Name:Pfizer Inc.
    Full Title: AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER SPONSORED AVELUMAB CLINICAL STUDIES
    Medical condition: This Master Protocol for Avelumab Continuation Sub-Studies has been designed to accommodate continued access to study intervention, safety follow-up, and when applicable, overall survival follow up...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) DK (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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