OncoMatch/Clinical Trials/NCT06225427
Gilteritinib for the Treatment of ALK NSCLC
Is NCT06225427 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Gilteritinib for lung non-small cell carcinoma.
Treatment: Gilteritinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK fusion
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: ALK inhibitor (crizotinib, ceritinib, brigatinib, alectinib, lorlatinib)
Prior 1st generation ALK tyrosine kinase inhibitor (TKI) (crizotinib) and/or prior 2nd generation TKI (ceritinib, brigatinib, alectinib) and/or lorlatinib
Cannot have received: FLT3 inhibitor
Received prior therapy with a FLT3 inhibitor
Lab requirements
Blood counts
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)
Kidney function
Measured or calculated creatinine clearance (CrCl) ≥ 50mL/min (calculated per Cockcroft-Gault formula)
Liver function
Serum total bilirubin ≤ 1.5 X ULN (per institutional guidelines) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases; ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases; Albumin ≥ 2.5g/dL
Cardiac function
Mean triplicate screening electrocardiogram (EKG) corrected QT (QTc) ≤ 480 ms; Grade 3 or 4 NYHA congestive heart failure excluded unless LVEF ≥ 45%
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 ULN (per institutional guidelines) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases; ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases; Albumin ≥ 2.5g/dL; Mean triplicate screening electrocardiogram (EKG) corrected QT (QTc) ≤ 480 ms; Grade 3 or 4 NYHA congestive heart failure excluded unless LVEF ≥ 45%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
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