non-small cell lung cancer non-small cell lung cancer, ALK rearrangement, lorlatinib-resistant, lorlatinib-intolerant
Conditions
Interventions
Gilteritinib is administered orally at a dose of 120 mg once daily and continued until disease progression is observed or unacceptable disease or other symptoms appear.
D058990
gilteritinib, molecular targeted therapy
Sponsors
Ichihara Eiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed non-small cell lung cancer. 2) Stage III/IV (UICC 8th edition) or recurrent cases that are difficult to treat curatively. 3) The patient has an ALK fusion gene (regardless of the testing method. However, the test must be approved as a companion diagnostic for various ALK inhibitors.) 4) Previously treated with lorlatinib and has become resistant or is not tolerated. 5) The patient is at least 18 years of age at the time consent is obtained. 6) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 7) Expected survival of at least 3 months after enrollment. 8) Neutrophil count greater than or equal to 1500/microL 9) Platelet count greater than or equal to 100,000/microL 10) Standard eGFR greater than or equal to 40 mL/min/1.73 m2 11) Hemoglobin greater than or equal to 9 g/dL without transfusion or erythropoietin dependence 12) Serum total bilirubin less than or equal to 1.5 x upper limit of institutional normal (ULN) or total bilirubin more than 1.5 x upper limit of institutional normal and direct bilirubin less than or equal to ULN 13) AST less than or equal to 2.5 x ULN or less than or equal to 5 x ULN if liver metastases are present 14) ALT less than or equal to 2.5 x ULN or liver metastasis less than or equal to 5 x ULN 15) Women of childbearing potential must have a negative serum pregnancy test within 21 days of enrollment prior to the first dose of gilteritinib. 16) Women of childbearing potential must be willing to use contraceptive methods for the duration of study participation. 17) Males whose partner has childbearing potential must be willing to use contraceptive methods for the duration of study participation. 18) Must have the ability to swallow tablets orally and have no significant problems limiting drug absorption. 19) Must understand informed consent and be willing to sign a consent form. 20) Must have measurable lesions according to RECIST v1.1 criteria as assessed by screening imaging.
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to gilteritinib or excipients 2) Complicated interstitial pneumonia. (except for very slight nonspecific interstitial shadows identified on chest CT) 3) Received palliative radiation within 7 days prior to enrollment. 4) Have confirmed active and symptomatic central nervous system (CNS) metastases and/or cancerous meningitis. (Patients with previously treated brain metastases may participate provided they are stable (clinically asymptomatic, at least 2 weeks since completion of treatment) and have not used more than 10 mg/day of prednisolone equivalent steroids for at least 7 days prior to enrollment. (No repeat brain MRI is required to demonstrate stability.) 5) Complicated liver cirrhosis of Child-Pugh class C or higher. 6) Has a history of QT prolongation syndrome or torsade de pointes. 7) ECG-corrected QT (QTc) longer than 480 ms at screening 8) Grade 3/4 NYHA congestive heart failure (unless echocardiography confirms LVEF (left ventricular ejection fraction) more than or equal to 45%) 9) Patients who have undergone major surgery requiring general anesthesia (excluding surgery for biopsy, etc.) within 4 weeks prior to the start of the study. 10) Active and untreated hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; patients with treatment initiated HBV and HCV will be allowed as long as they meet AST/ALT and bilirubin criteria 11) Pregnant, lactating, or expecting pregnancy or delivery within the anticipated study period from informed consent to 180 days after the last dose of study medication. 12) Otherwise determined by the principal investigator or study investigator to have a condition that jeopardizes the safety of the study subject or precludes evaluation of gilteritinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease or the like, defined as any disease, disability, death or infection which is suspected of being due to the conduct of the clinical trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Response rate and disease control rate 2) Progression-free survival rate and time to progression at 6 months 3) Overall survival rate and overall survival time at 6 months | — |
Contacts
Public ContactAyako Morita
Okayama University Hospital
Outcome results
None listed