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Lung Non-Small Cell CarcinomaPhase 1NCT06225427

Gilteritinib for the Treatment of ALK NSCLC

A Phase 1 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with Lung Non-Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy, Biospecimen Collection and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited States
Study dates
25 Jul 2024to May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.
  • If the patient is symptomatic, there is vasogenic edema, and/or there is midline shift, the patient will need to undergo treatment for these brain metastases and meet exclusion criteria #4 exception to treated brain metastases prior to enrollment. A new MRI brain is NOT required in this situation
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites, 3 recruiting

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

    Angel Qin, 734-647-8902, qina@med.umich.edu

    Angel Qin

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Maria Tarallo, 310-423-1840, Maria.Tarallo@cshs.org

    Kamya Sankar, MD

    Not yet recruiting

  • Georgetown University

    Washington D.C., District of Columbia, 20007

    Mathew Caffet, 202-444-2223, Mc2731@georgetown.edu

    Joshua Reuss, MD

    Not yet recruiting

Other trials in United States

About this study

Official title: Phase I Study of Gilteritinib for ALK Positive Non-Small Cell Lung Cancer

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.

Being tested
Biopsy, Biospecimen Collection, Computed Tomography, Echocardiography, Gilteritinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tissue biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo echocardiography

  • GilteritinibDrug

    Also called ASP-2215, ASP2215

    Given PO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06225427
Study groupRoleWhat they receive
Treatment (gilteritinib)ExperimentalPatients 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.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography; Drug: Gilteritinib; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Safety will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

    Measured: Up to 30 days after last dose of gilteritinib

  2. Dose-limiting toxicities (DLT)

    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.

    Measured: Cycle 1 day 1 up to cycle 2 day 1 (each cycle is 21 days)

Secondary outcomes (3)

  1. Anti-tumor response

    Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. Best responses including complete response, partial response, stable disease and progressive disease will be determined by independent radiology assessment.

    Measured: Up to 2 years after last dose of gilteritinib

  2. Progression-free survival (PFS)

    Determined by RECIST v 1.1.

    Measured: From start of treatment to time of progression, assessed up to 2 years after last dose of gilteritinib

  3. Overall survival (OS)

    Median OS and associated 95% confidence intervals will be assessed and reported using the Kaplan-Meier method.

    Measured: Cycle 1 day 1 of study start to date of death from any cause, assessed up to 2 years from last dose of gilteritinib

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start25 Jul 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06225427
Sponsor's protocol ID
UMCC 2023.047
Other IDs
NCI-2023-10639, UMCC 2023.047
Status last verified
Jun 2026
First submitted
13 Jan 2024
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with Lung Non-Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to 30 days after last dose of gilteritinib). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06225427.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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