Condition: Non-small Cell Lung Cancer (NSCLC) · Anaplastic Lymphoma Kinase (ALK) Positive · Sponsor: Astellas Pharma Global Development, Inc.
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.
Astellas Pharma Global Development, Inc. · 800-888-7704 · Astellas.registration@astellas.com
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| Providence Medical Foundation - Fullerton - Virginia K. Crosson Cancer Center | Fullerton, California, United States | Recruiting |
| University of California - Irvine | Orange, California, United States | Recruiting |
| Emory Winship Cancer Institute | Atlanta, Georgia, United States | Recruiting |
| OSF Health Care | Peoria, Illinois, United States | Recruiting |
| University of Michigan Health Systems | Ann Arbor, Michigan, United States | Recruiting |
| Washington University School of Medicine | St Louis, Missouri, United States | Recruiting |
| Hackensack University Medical Center | Hackensack, New Jersey, United States | Recruiting |
| UT Southwestern Medical Center at Dallas | Dallas, Texas, United States | Recruiting |
| Virginia Cancer Specialists PC | Fairfax, Virginia, United States | Recruiting |
| Site FR33008 | Saint-Herblain, France | Recruiting |
| Site FR33005 | Toulouse, France | Recruiting |
| Site FR33001 | Villejuif, France | Recruiting |
+ 4 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07140016