Gilteritinib for the Treatment of ALK NSCLC

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT06225427
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Lung Non-Small Cell Carcinoma
  • Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Echocardiography — PROCEDURE
    Undergo echocardiography
  • Gilteritinib — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jul 25, 2024
Status verified
Oct 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (gilteritinib)
    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.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 30 days after last dose of gilteritinib ]

Locations (3)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Maria Tarallo
[email protected]
310-423-1840
Kamya Sankar, MD (PRINCIPAL_INVESTIGATOR)
Georgetown UniversityWashington D.C.District of Columbia20007
Mathew Caffet
[email protected]
202-444-2223
Joshua Reuss, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109
Angel Qin
[email protected]
734-647-8902
Angel Qin (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAGeorgetown University· Washington D.C., DCUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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