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Study identifier: NCT07140016 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)

Condition: Non-small Cell Lung Cancer (NSCLC) · Anaplastic Lymphoma Kinase (ALK) Positive  ·  Sponsor: Astellas Pharma Global Development, Inc.

PhasePhase 1
Planned participants40
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with non small cell lung cancer (NSCLC) have a faulty ALK gene. ALK stands for anaplastic lymphoma kinase. People with NSCLC who have the faulty ALK gene are called ALK-positive. ALK inhibitors are an approved treatment for people with ALK positive NSCLC. Some people stop responding to treatment with ALK inhibitors over time due to more changes happening in their faulty ALK gene, so there is an unmet medical need. Gilteritinib is an approved treatment for people with acute myeloid leukemia (AML) with the faulty FLT3 gene who haven't responded to previous treatment, or their cancer came back after previous treatment. Gilteritinib also blocks changes in the ALK gene which could help people with ALK-positive NSCLC. A study needs to be done with gilteritinib in people with ALK-positive NSCLC. The main aim of the study is to check the safety of gilteritinib in people with ALK-positive NSCLC and if they tolerate gilteritinib. People in this study will be adults with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC). Locally advanced means the cancer has spread to nearby tissue. Metastatic means the cancer has spread to other parts of the body. They have stopped responding to treatment with ALK inhibitors, including alectinib or lorlatinib, over tim…

This description comes directly from the study's public registry record.

Talk to the study team

Astellas Pharma Global Development, Inc.  ·  800-888-7704  ·  Astellas.registration@astellas.com

Always discuss trial participation with your own doctor first.

Locations (16)

Providence Medical Foundation - Fullerton - Virginia K. Crosson Cancer CenterFullerton, California, United StatesRecruiting
University of California - IrvineOrange, California, United StatesRecruiting
Emory Winship Cancer InstituteAtlanta, Georgia, United StatesRecruiting
OSF Health CarePeoria, Illinois, United StatesRecruiting
University of Michigan Health SystemsAnn Arbor, Michigan, United StatesRecruiting
Washington University School of MedicineSt Louis, Missouri, United StatesRecruiting
Hackensack University Medical CenterHackensack, New Jersey, United StatesRecruiting
UT Southwestern Medical Center at DallasDallas, Texas, United StatesRecruiting
Virginia Cancer Specialists PCFairfax, Virginia, United StatesRecruiting
Site FR33008Saint-Herblain, FranceRecruiting
Site FR33005Toulouse, FranceRecruiting
Site FR33001Villejuif, FranceRecruiting

+ 4 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07140016