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Gilteritinib for the Treatment of ALK NSCLC | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Gilteritinib for the Treatment of ALK NSCLC

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

NCT06225427•University of Michigan Rogel Cancer Center

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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+15 more criteria

Exclusion Criteria

•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
+8 more criteria

Locations (3)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Georgetown University

Washington D.C., District of Columbia, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Key Dates

Start Date

July 25, 2024

Primary Completion Date

May 1, 2027

Completion Date

May 1, 2027

Last Updated

October 20, 2025

Enrollment

ESTIMATED participants

Conditions

Lung Non-Small Cell CarcinomaStage IV Lung Cancer AJCC v8

Interventions

Biopsy

PROCEDURE

Biospecimen Collection

PROCEDURE

Computed Tomography

PROCEDURE

Echocardiography

PROCEDURE

Gilteritinib

DRUG

Magnetic Resonance Imaging

PROCEDURE

Questionnaire Administration

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Gilteritinib for the Treatment of ALK NSCLC

Inclusion Criteria

Exclusion Criteria

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

Grid Radiation Therapy for the Treatment of Stage IV Non-Small Cell Lung Cancer

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer

Phase II Trial of Lung Chemoemobolization