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

Part of paid clinical trials in Orange, California.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT07140016
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Anaplastic Lymphoma Kinase (ALK) Positive
  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • gilteritinib — DRUG
    Oral

Study Details

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.

Key Dates

Start date
Sep 22, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: gilteritinib
    Participants will receive gilteritinib once daily in a 28-day cycle. For participants who are tolerant and achieve stable disease after 2 scans, a dose increase will be allowed.

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 Days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of California - IrvineOrangeCalifornia92868-
Emory Winship Cancer InstituteAtlantaGeorgia30322-
OSF Health CarePeoriaIllinois61637-
University of Michigan Health SystemsAnn ArborMichigan48109-
Washington University School of MedicineSt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
UT Southwestern Medical Center at DallasDallasTexas75390-
Virginia Cancer Specialists PCFairfaxVirginia22031-

Find similar trials in Orange, CA

By research site
University of California - Irvine· Orange, CAEmory Winship Cancer Institute· Atlanta, GAOSF Health Care· Peoria, ILUniversity of Michigan Health Systems· Ann Arbor, MIWashington University School of Medicine· St Louis, MOHackensack University Medical Center· Hackensack, NJ

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