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

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 i

Trial Details

NCT ID
NCT07140016
Phase
PHASE1
Sponsor
Astellas Pharma Global Development, Inc.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • gilteritinib
Locations (sample)
  • Orange, California, United States|33.78779,-117.85311
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Peoria, Illinois, United States|40.69365,-89.58899
  • Ann Arbor, Michigan, United States|42.27756,-83.74088
  • St Louis, Missouri, United States|38.62727,-90.19789

Key Eligibility Criteria

  • Participant has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) with a documented anapl…
  • Participant is willing to submit, prior to enrollment, a fresh tumor tissue sample that was collected after completion of the most recent anti-canc…
  • Participant must have at least one prior line of ALK inhibitor-based therapy and meet one of the following criteria:
  • Participant received alectinib as the only prior ALK inhibitor regimen. Participant is ineligible or unable to tolerate approved and available seco…

For full eligibility, visit ClinicalTrials.gov.

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