NCT07140016

A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)

Recruiting now Phase 1 Last updated 7 April 2026

What this trial tests

Phase 1 trial testing gilteritinib in Non-small Cell Lung Cancer (NSCLC) in 40 participants. Currently enrolling.

Timeline

22 September 2025

Primary endpoint
31 December 2029

31 December 2029

Quick facts

Lead sponsor	Astellas Pharma Global Development, Inc.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	22 September 2025
Primary completion	31 December 2029
Estimated completion	31 December 2029
Sites	10 locations across United States, Spain

Drugs / interventions tested

• gilteritinib (GILTERITINIB) — full drug profile →

Conditions studied

• Non-small Cell Lung Cancer (NSCLC) — all drugs for Non-small Cell Lung Cancer (NSCLC) →
• Anaplastic Lymphoma Kinase (ALK) Positive — all drugs for Anaplastic Lymphoma Kinase (ALK) Positive →

Sponsor

Astellas Pharma Global Development, Inc. — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer (NSCLC) or Anaplastic Lymphoma Kinase (ALK) Positive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with non small cell lung cancer (NSCLC) have a faulty ALK gene. ALK stands for anaplastic lymphoma kinase. People with NSCLC who have the faulty ALK gene are called ALK-positive. ALK inhibitors are an approved treatment for people with ALK positive NSCLC. Some people stop responding to treatment with ALK inhibitors over time due to more changes happening in their faulty ALK gene, so there is an unmet medical need. Gilteritinib is an approved treatment for people with acute myeloid leukemia (AML) with the faulty FLT3 gene who haven't responded to previous treatment, or their cancer came back after previous treatment. Gilteritinib also blocks changes in the ALK gene which could help people with ALK-positive NSCLC. A study needs to be done with gilteritinib in people with ALK-positive NSCLC.

The main aim of the study is to check the safety of gilteritinib in people with ALK-positive NSCLC and if they tolerate gilteritinib.

People in this study will be adults with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC). Locally advanced means the cancer has spread to nearby tissue. Metastatic means the cancer has spread to other parts of the body. They have stopped responding to treatment with ALK inhibitors, including alectinib or lorlatinib, over time. The key reasons people cannot take part are if they have symptomatic cancers in the brain or nervous system, their cancer has spread to the thin tissue that covers the brain and spinal cord (leptomengingeal metastasis), have recently had or planning to have major surgery, have certain heart conditions, or have recently had an infection, a stroke or mini-stroke.

People in the study will take tablets of gilteritinib once a day in a 28-day cycle. They may be given up to 2 different doses of gilteritinib. People in the study will start on the lower dose but can eventually switch to the higher dose if they tolerate the lower dose and meet the safety checks.

Whilst taking gilteritinib, people will have regular scans of their tumors. People will continue taking gilteritinib until their cancer gets worse, they have medical problems from gilteritinib that they can't tolerate, they ask to stop taking gilteritinib, they start other cancer treatment or, sadly pass away. People will visit the clinic about 7 days and then 30 days after they stop taking gilteritinib. They will be asked about any medical problems and will have a safety check. After this, people who stopped taking gilteritinib, but their cancer hadn't become worse, will continue to have regular scans of their tumors. If their cancer does get worse, they will no longer have scans of their tumors. After finishing gilteritinib, people will be phoned every 12 weeks to check on their health. People will be in the study for up to 4 years, depending on how they respond to gilteritinib.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Successful and On-going Long-Term Disease Control (>24 Months) with Gilteritinib in an <i>ALK+</i> NSCLC Patient with Brain Metastasis Who Has Progressed on Multiple ALK TKIs. A Case Report and Review of Literature on Gilteritnib.
   Ou SI, Park CJ, Arter ZL, Nagasaka M. · · 2025 · PMID 41158152 · DOI 10.2147/lctt.s547128