Who is eligible for clinical trial NCT06225427?

Participants must meet the protocol's inclusion criteria for Lung Non-Small Cell Carcinoma. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06225427 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

Gilteritinib for the Treatment of ALK NSCLC (NCT06225427)

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

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: University of Michigan Rogel Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (25 items) and avoid the listed exclusions (20 items).

Location: Cedars-Sinai Medical Center — Los Angeles, California

Age range: 18 Years

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

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.
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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

Cedars-Sinai Medical Center — Los Angeles, California
Georgetown University — Washington D.C., District of Columbia
University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan

📞 Contact the Study Coordinator

Phone: (310) 423-1840

Email: Maria.Tarallo@cshs.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗