Leukemia drug repurposed for hard-to-treat lung cancer in early trial

NCT ID NCT07140016

Recruiting now Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tests gilteritinib, a drug already approved for a type of leukemia, in about 40 adults with ALK-positive non-small cell lung cancer whose tumors no longer respond to standard ALK inhibitors. Participants take gilteritinib tablets daily in 28-day cycles. The main goal is to check safety and tolerability, while also looking at whether tumors shrink. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: gilteritinib
What this could lead to: If it works, this could point toward a new treatment option for people with ALK-positive lung cancer whose current drugs have stopped working.
What could go wrong: This is a very early (Phase 1b) and small (40 people) study focused mainly on safety, not yet on effectiveness. The drug may not shrink tumors or may cause side effects that limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

ALK-positive anaplastic large cell lymphoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)

Contacts and locations

Locations

Emory Winship Cancer Institute
RECRUITING

Atlanta, Georgia, 30322, United States
Hackensack University Medical Center
RECRUITING

Hackensack, New Jersey, 07601, United States
OSF Health Care
RECRUITING

Peoria, Illinois, 61637, United States
Providence Medical Foundation - Fullerton - Virginia K. Crosson Cancer Center
RECRUITING

Fullerton, California, 92835, United States
Site ES34006
RECRUITING

Madrid, Spain
Site ES34008
RECRUITING

Málaga, Spain
Site ES34011
RECRUITING

Madrid, Spain
Site ES34017
RECRUITING

Barcelona, Spain
Site FR33001
RECRUITING

Villejuif, France
Site FR33005
RECRUITING

Toulouse, France
Site FR33008
RECRUITING

Saint-Herblain, France
UT Southwestern Medical Center at Dallas
RECRUITING

Dallas, Texas, 75390, United States
University of California - Irvine
RECRUITING

Orange, California, 92868, United States
University of Michigan Health Systems
RECRUITING

Ann Arbor, Michigan, 48109, United States
Virginia Cancer Specialists PC
RECRUITING

Fairfax, Virginia, 22031, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States

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