ALK-rearranged advanced NSCLC
Conditions
Interventions
None listed
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: 1) Patients with advanced (stage IIIB, IIIC, IVA, or IVB) or postoperative recurrent non-small-cell lung cancer with ALK gene translocation unamenable to radical treatment 2) Patients who received prior treatment meeting either of the following: Cohort A (Brigatinib as 2nd or 3rd line) 1. Alectinib monotherapy as 1st line, or as 2nd line following chemotherapy*1 2. Alectinib is the most recent regimen. Cohort B (Brigatinib as 3rd to 5th line) 1. Alectinib monotherapy as 1st line, or as 2nd line following chemotherapy (1 regimen) 2. Alecitinib was followed by chemotherapy (1 regimen) and/or lorlatinib 3. Chemotherapy or lorlatinib was the most recent regimen. Cohort 0 (Brigatinib as 1st or 2nd line) 1. No history of ALK inhibitors 2. No previous systemic treatment or one chemotherapy as 1st line. 3) Patients planned to receive brigatinib monotherapy in clinical practice according to the current labeled indication for brigatinib 4) Patients in whom evaluation by chest CT and brain CT or MRI is performed within 42 days and 56 days, respectively, before initiation of brigatinib (for both CT and MRI, contrast-enhanced scans are preferable) (Images performed before initiation of prior treatment are not acceptable even if they are performed within 42 days before initiation of brigatinib.) 5) Age 20 years or older at the time of informed consent. 6) Patients who have been fully informed of the content of this clinical study and personally provided voluntary written informed consent
Exclusion criteria
Exclusion criteria: Patients for whom the attending physician judged that participation in this clinical study is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed