Real-world outcomes of brigatinib compared to alectinib as a second-line therapy after crizotinib in advanced anaplastic lymphoma kinase positive non-small cell lung cancer patients
- Conditions
- Neoplasms
- Registration Number
- KCT0005952
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Male or female adult patients aged 18 years old and above
2. Patients who were diagnosed as locally advanced or metastatic NSCLC from Jan 2011
3. Patients who were diagnosed as histologically or cytologically ALK positive adenocarcinoma
4. Patients who initiated crizotinib as a first-line therapy and experienced disease progression
(definitive CCRT, neoadjuvant or adjuvant chemotherapy prior to crizotinib are allowed)
5. Patients who were treated with crizotinib for at least 84 days
6. Patients who are eligible to evaluate response to brigatinib or alectinib
7. Patients who provide written informed consent for the study
1. Patients who were treated with ALK inhibitors other than alectinib or brigatinib after crizotinib failure
2. Patients who stopped a first-line crizotinib treatment for other than disease progression
3. Patients who received chemotherapy in between crizotinib and 2nd line ALK inhibitor
4. Patients whose medical records are not available for review
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method objective response rate (ORR), intracranial objective response rate (IC-ORR), duration of response (DR), intracranial duration of response (IC-DR), time to progression (TTP), intracranial time to progression (IC-TTP), and extracranial time to progression (EC-TTP);disease control rate (DCR) and intracranial disease control rate (IC-DCR) at 6 and 12 weeks;Safety and tolerability