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

Researching Gilteritinib for advanced ALK-positive lung cancer in adults.

Recruiting
18 years and older
All
Phase 1

Non-small cell lung cancer (NSCLC) is a type of lung cancer. Some people with NSCLC have a faulty gene called ALK, which stands for anaplastic lymphoma kinase. This study is for people whose cancer stopped responding to ALK inhibitor treatments. The study will test a drug called gilteritinib, already used for another cancer type, to see if it helps people with ALK-positive NSCLC.

Participants will take gilteritinib pills once a day in 28-day cycles. Regular tumor scans will be done to check progress. They will stay in the study for up to 4 years, depending on their response to the drug. Visits to the clinic are required after stopping the drug for safety checks and reports on health will continue every 12 weeks.

  • The study lasts up to 4 years, with regular clinic visits and scans.
  • Participants will take daily pills of gilteritinib.
  • Eligibility: Cannot have recent surgeries, certain heart conditions, or brain cancer symptoms.
Study details
    Non-small Cell Lung Cancer (NSCLC)
    Anaplastic Lymphoma Kinase (ALK) Positive

NCT07140016

Astellas Pharma Global Development, Inc.

11 July 2026

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