Gilteritinib for the Treatment of ALK NSCLC

This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments. While there are many approved targeted drugs for ALK NSCLC, resistance to these drugs frequently occur. Giltertinib is a drug that is already FDA approved for the treatment of a specific type of leukemia. However, studies using ALK positive lung cancer cells demonstrate activity of gilteritinib against these resistant cells. Therefore, in this clinical trial, the investigators plan to s

Trial Details

NCT ID
NCT06225427
Phase
PHASE1
Sponsor
University of Michigan Rogel Cancer Center
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography
  • Gilteritinib
  • Magnetic Resonance Imaging
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Ann Arbor, Michigan, United States|42.27756,-83.74088

Key Eligibility Criteria

  • Stage IV (American Joint Committee on Cancer \[AJCC\] 8th edition) non-small cell lung cancer with an oncogenic ALK fusion
  • Histologies include adenocarcinoma, squamous cell carcinoma, adenosquamous adenocarcinoma, and NSCLC NOS (not otherwise specified)
  • The presence of an oncogenic ALK fusion established from any Clinical Laboratory Improvement Act (CLIA) certified laboratory
  • The patient must belong to one of the following treatment cohorts.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Non-Small Cell (NSCLC) Lung Cancer Trials on Trialify →