Gilteritinib for ALK-Positive Non-Small Cell Lung Cancer
This study is testing a drug called gilteritinib for people with stage IV non-small cell lung cancer (NSCLC) that has a specific change called an ALK fusion. This drug works as a kinase inhibitor, targeting certain proteins in cancer cells. You might be able to join if your cancer has an ALK fusion and has progressed on other treatments. Researchers want to find out how safe gilteritinib is and what side effects it might cause. They will also look for the best dose. This study plans to include 30 participants. The main goals are to track any side effects and serious reactions to the drug.
- Study design
- This is a Phase 1 interventional study, meaning it tests a new treatment in a small group of people. It plans to enroll 30 participants.
- What's involved
- You will undergo a tissue biopsy, blood sample collection, CT scans, and echocardiography. You will take gilteritinib by mouth.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor for side effects for up to 30 days after your last dose of gilteritinib.
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NCT06225427
Gilteritinib for the Treatment of ALK NSCLC
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of Michigan Rogel Cancer CenterInvestigator-initiated
~30 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyEchocardiographyGilteritinibMagnetic Resonance Imaging
At a glance
Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 30 days after last dose of gilteritinib
+1 more outcome measured
Conditions
Where it's being run
3 sites across 3 statesCalifornia1
District of Columbia1
Michigan1
Study leadership
- Angel Qin · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Stage IV (American Joint Committee on Cancer \[AJCC\] 8th edition) non-small cell lung cancer with an oncogenic ALK fusion
Histologies include adenocarcinoma, squamous cell carcinoma, adenosquamous adenocarcinoma, and NSCLC NOS (not otherwise specified)
The presence of an oncogenic ALK fusion established from any Clinical Laboratory Improvement Act (CLIA) certified laboratory
The patient must belong to one of the following treatment cohorts.
Cohort 1: Prior 1st generation ALK tyrosine kinase inhibitor (TKI) (crizotinib) and/or prior 2nd generation TKI (ceritinib, brigatinib, alectinib) and/or lorlatinib
Cohort 2: Prior 1st generation ALK TKI (crizotinib) and/or prior 2nd generation TKI (ceritinib, brigatinib, alectinib) and/or lorlatinib, and platinum-doublet chemotherapy
Cohort 3: Prior 1st generation ALK TK (crizotinib) and/or prior 2nd generation TKI (ceritinib, brigatinib, alectinib) and/ or lorlatinib, platinum-doublet chemotherapy, and any other number of antineoplastic agents (including immunotherapy, standard or investigational)
Age ≥ 18
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Absolute neutrophil count (ANC) ≥ 1500/mcL
Platelets ≥ 100,000/mcL
Hemoglobin ≥ 9 g/dL without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
Measured or calculated creatinine clearance (CrCl) ≥ 50mL/min (calculated per Cockcroft-Gault formula)
Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) (per institutional guidelines) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
Albumin ≥ 2.5g/dL
Female subject of childbearing potential should have a negative serum pregnancy test within 21 days of enrollment prior to receiving the first dose of study medication
Female subjects of childbearing potential must be willing to use a highly effective method of contraception for the course of the study, through 180 days after the last dose of study medication. Note: Abstinence is acceptable, if patient documents that this is their usual lifestyle or preferred contraception method
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 4 months after the last dose of study therapy. Note: Abstinence is acceptable, if patient documents that this is their usual lifestyle or preferred contraception method
Ability to swallow pills orally and per investigator's assessment, do not have any significant issues limiting absorption of drug
Ability to understand and the willingness to sign a written informed consent
Measurable disease per RECIST v1.1 criteria assessed per screening imaging
If a cancerous lesion is easily and safely accessible, a pre-treatment biopsy of this lesion is strongly encouraged but NOT required prior to first dose of gilteritinib. Archival or fresh tissue biopsy may be used as long as it was obtained prior to cycle 1 day 1 (C1D1)
At least 7 days must have elapsed since last anti-neoplastic TKI, chemotherapy, immunotherapy, or investigational agent prior to the first dose of gilteritinib
Exclusion
Received palliative radiation within 7 days of enrollment
Received prior therapy with a FLT3 inhibitor
Has a concurrent active malignancy receiving interventional therapy unless it is the investigator's opinion that the concurrent active malignancy will NOT significantly impact the survival of the patient (i.e. early stage breast cancer or prostate cancer on hormonal therapy, basal cell carcinoma awaiting Moh's or other surgery and the respective interventional therapy does NOT interact or interfere with gilteritinib.
Has known active and symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
Subjects with previously treated brain metastases may participate provided they are stable (clinically asymptomatic, and ≥ 2 weeks since completion of treatment) and are not using steroids for at least 7 days prior to enrollment. A repeat MRI brain is not necessary to document stability
Patients with carcinomatous meningitis are excluded regardless of clinical stability
If a patient is found to have new/enlarging brain metastases on the screening MRI, the patient may be monitored closely and radiation could be delayed if the patient has no symptoms, there is no vasogenic edema, and there is no evidence of midline shift.
Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment
Has Child-Pugh class C cirrhosis from any cause
Mean triplicate screening electrocardiogram (EKG) corrected QT (QTc) \> 480 ms. (QTc Framingham will be used for heart rate \>100 bpm)
Grade 3 or 4 NYHA (New York Heart Association) congestive heart failure, unless screening echocardiogram obtained prior to enrollment showed a LVEF (left ventricular ejection fraction) ≥ 45%
Surgery within 4 weeks prior to first study dose
Requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A
Requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the patient
Requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor, with the exception of drugs that are considered absolutely essential for the care of the patient
Active/untreated hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; patients with treated HBV and HCV are allowed as long as they meet the AST/ALT and bilirubin criteria
Known hypersensitivity to gilteritinib or any of the excipients
Active and clinically significant pancreatitis
What this trial measures
- Incidence of adverse eventsUp to 30 days after last dose of gilteritinib
Safety will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
- Dose-limiting toxicities (DLT)Cycle 1 day 1 up to cycle 2 day 1 (each cycle is 21 days)
Toxicities will be assessed by CTCAE v 5.0. DLT's will be defined as \>= grade 4 hematologic toxicities, \>= grade 3 febrile neutropenia, \>= grade 3 non-hematologic toxicities, and posterior reversible encephalopathy syndrome of any grade. Toxicity will be quantified by reporting the proportion of patients who experience a DLT at the identified maximum tolerated dose and by reporting a 95% confidence interval for this proportion.