This is a single-arm, phase II study of dacomitinib in advanced EGFR-mutant NSCLC patients who have non-irradiated brain metastasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Secondary generation EGFR-tyrosine kinase inhibitor (TKI) (Dacomitinib) for EGFR mutant NSCLC patients with non irradiated brain metastasis
Jong-Mu Sun
Seoul, South Korea
RECRUITINGCNS objective response rate (Complete response or Partial response)
The rate of CR or PR of CNS disease
Time frame: 1 year
CNS progression-free survival
Time from enrollment to CNS progression or death
Time frame: 1 year
Cumulative incidence of CNS failure by competing risk analysis
To evaluate the CNS efficacy of dacomitinib
Time frame: 1 year
Extracranial objective response rate
The rate of CR or PR
Time frame: 1 year
Progression-free survival
Time from enrollment to progression or death
Time frame: 1 year
Overall survival
Time from enrollment to death of any cause
Time frame: 1 year
Safety by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
The % of side effect
Time frame: 1 year
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