Actively Recruiting
Gilteritinib for the Treatment of ALK NSCLC
Led by University of Michigan Rogel Cancer Center · Updated on 2025-10-20
30
Participants Needed
3
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gilteritinib for the Treatment of ALK NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stage IV non-small cell lung cancer with an oncogenic ALK fusion confirmed by a certified laboratory
- Histologies include adenocarcinoma, squamous cell carcinoma, adenosquamous adenocarcinoma, and NSCLC not otherwise specified
- Prior treatment with 1st and/or 2nd generation ALK tyrosine kinase inhibitors, with or without platinum-doublet chemotherapy and other antineoplastic agents depending on cohort
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Absolute neutrophil count of 1500/mcL or higher
- Platelet count of 100,000/mcL or higher
- Hemoglobin level of 9 g/dL or higher without recent transfusion or erythropoietin dependency
- Creatinine clearance of 50 mL/min or greater
- Serum total bilirubin less than or equal to 1.5 times upper limit of normal or direct bilirubin within normal limits if total bilirubin is higher
- AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times upper limit of normal or up to 5 times if liver metastases present
- Albumin level of 2.5 g/dL or higher
- Negative pregnancy test for females of childbearing potential within 21 days prior to enrollment
- Agreement to use highly effective contraception during the study and for specified periods after last dose
- Ability to swallow pills and no significant issues limiting drug absorption
- Ability to understand and sign informed consent
- Measurable disease by RECIST v1.1
- Encouraged but not required pre-treatment biopsy if lesion accessible
- At least 7 days since last anti-neoplastic treatment before first dose of gilteritinib
You will not qualify if you...
- Receipt of palliative radiation within 7 days before enrollment
- Prior therapy with a FLT3 inhibitor
- Concurrent active malignancy receiving interventional therapy unless not expected to affect survival
- Known active and symptomatic central nervous system metastases or carcinomatous meningitis; stable treated brain metastases allowed under conditions
- Newly found brain metastases with symptoms or edema requiring treatment prior to enrollment
- Pregnancy, breastfeeding, or intention to conceive or father children during and for 180 days after treatment
- Child-Pugh class C cirrhosis
- Corrected QT interval (QTc) greater than 480 ms on ECG
- Severe congestive heart failure unless preserved left ventricular ejection fraction
- Surgery within 4 weeks prior to first study dose
- Use of strong CYP3A inducers or P-glycoprotein inhibitors/inducers (except essential medications)
- Use of drugs targeting certain serotonin receptors or sigma receptors unless essential
- Active untreated hepatitis B or C infection
- Known allergy to gilteritinib or its ingredients
- Active and clinically significant pancreatitis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
2
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
3
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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