Non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
Kobe Minimally Invasive Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with unresectable advanced or recurrent NSCLC 2) ALK-positive confirmed by validated tests 3) Age 18 or older at the time consent is obtained 4) No history of ALK-TKI treatment 5) Lorlatinib at 100 mg once daily is scheduled to be administered 6) CNS metastasis with a maximum diameter of 5 mm or more and 2 times the slice width on head MRI (contrast MRI whenever possible, within 42 days prior to registration in principle, when selecting a lesion with a long diameter of 5-10 mm, carefully check that the MRI slice thickness is half or less of the long diameter) 7) Patients who have had a chest CT scan within 42 days prior to enrollment (regardless of whether or not there are measurable lesions other than CNS metastases) 8) Expected to survive at least 12 weeks at time of enrollment
Exclusion criteria
Exclusion criteria: No exclusion criteria in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central nervous system metastases complete response rate: CNS-CR rate | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Overall survival (OS) (2) Overall response rate (ORR) (3) Progression free survival (PFS) (4) Response rate for CNS metastases (CNS-ORR) (5) Progression-free survival for CNS metastases (CNS-PFS) (6) Safety | — |
Countries
Japan
Contacts
Public ContactTeppei Yamaguchi
Aichi Cancer Center Hospital Department of Thoracic Oncology
Outcome results
None listed