NCT06225427

Gilteritinib for the Treatment of ALK NSCLC

Phase I Study of Gilteritinib for ALK Positive Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo tissue biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Echocardiography	Undergo echocardiography
DRUG	Gilteritinib	Given PO
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2024-07-25
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2024-01-26
• Last updated: 2025-10-20

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study