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Tyrosine Kinase Inhibitor

Gilteritinib for Lung Cancer

Phase 1

Recruiting

Led By Angel Qin

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stage IV non-small cell lung cancer with an oncogenic ALK fusion

The presence of an oncogenic ALK fusion established from any CLIA certified laboratory

Must not have

Received prior therapy with a FLT3 inhibitor

Known history of prior malignancy except for specified cases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment to time of progression, assessed up to 2 years after last dose of gilteritinib

Awards & highlights

Summary

This trial is testing the safety and effectiveness of a drug called gilteritinib in treating stage IV ALK positive non-small cell lung cancer (NSCLC) that has not responded to other treatments

Who is the study for?

This trial is for adults with stage IV ALK positive non-small cell lung cancer (NSCLC) who have not responded to other treatments. Participants must be able to undergo procedures like biopsies and scans, and complete questionnaires.

What is being tested?

The trial is testing the safety, side effects, and best dose of a drug called gilteritinib. This medication is approved for leukemia but will now be tested in patients with a specific type of resistant lung cancer.

What are the potential side effects?

Potential side effects of gilteritinib may include changes in heart rhythm, liver enzyme elevations, fatigue, nausea, diarrhea, blood count abnormalities and risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is stage IV with an ALK gene change.

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My cancer has an ALK gene change found by a certified lab.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

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My kidney function is good.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a FLT3 inhibitor before.

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I have had cancer before, but it fits the exceptions.

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My liver disease is severe.

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I have not had surgery in the last 4 weeks.

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I am currently suffering from severe pancreatitis.

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I need medication that strongly affects how drugs are absorbed in my body.

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I have severe heart failure.

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I need medication that strongly activates liver enzymes.

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I need medication that targets specific receptors in my body.

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I have active brain metastases or cancer in my brain's lining.

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I have an active hepatitis B or C infection that hasn't been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment to time of progression, assessed up to 2 years after last dose of gilteritinib

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment to time of progression, assessed up to 2 years after last dose of gilteritinib

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to time of progression, assessed up to 2 years after last dose of gilteritinib for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicities (DLT)

Incidence of adverse events

Secondary study objectives

Anti-tumor response

Overall survival (OS)

Progression-free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (gilteritinib)Experimental Treatment7 Interventions

Patients receive gilteritinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography at screening and blood sample collection, CT scan and MRI at screening and on study. Additionally, patients may undergo a tumor biopsy pre-treatment and at end of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 3

~2020

Echocardiography

2013

Completed Phase 4

~11580

Gilteritinib

2014

Completed Phase 2

~560

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Computed Tomography

2017

Completed Phase 2

~2740

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor

297 Previous Clinical Trials

24,196 Total Patients Enrolled

Angel QinPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center

~20 spots leftby May 2027

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