Phase I Study of Gilteritinib for ALK Positive Non-Small Cell Lung Cancer
University of Michigan Rogel Cancer Center
Summary
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 study the effect of giltertinib in patients with ALK NSCLC.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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. * Cohort 1: Prior 1st generation ALK tyrosine kinase inhibitor (TKI) (crizotinib) and/or prior 2nd generation TKI (ceritin…
Interventions
- ProcedureBiopsy
Undergo tissue biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureEchocardiography
Undergo echocardiography
- DrugGilteritinib
Given PO
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- OtherQuestionnaire Administration
Ancillary studies
Locations (3)
- Cedars-Sinai Medical CenterLos Angeles, California
- Georgetown UniversityWashington D.C., District of Columbia
- University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan