RecruitingPhase 1NCT06225427

Gilteritinib for the Treatment of ALK NSCLC

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

Sponsor

University of Michigan Rogel Cancer Center

Enrollment

30 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called gilteritinib — currently used for a different gene mutation in leukemia — can treat advanced non-small cell lung cancer (NSCLC) that has a specific ALK gene rearrangement and has stopped responding to standard ALK-targeted treatments. **You may be eligible if...** - You are 18 years old or older - You have stage IV (metastatic) non-small cell lung cancer with an ALK gene fusion (rearrangement) - You have received at least one prior ALK-targeted drug (such as crizotinib, alectinib, ceritinib, brigatinib, or lorlatinib) - Your overall health status is acceptable (ECOG 0–2) - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - Your cancer does not have an ALK gene rearrangement - You have severe liver or kidney impairment - You are pregnant or breastfeeding - You have active brain metastases that are unstable or symptomatic Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Los Angeles, California, United States

Georgetown University

Washington D.C., District of Columbia, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06225427

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