This is a single-arm, phase II study of dacomitinib in advanced EGFR-mutant NSCLC patients who have non-irradiated brain metastasis.
Name: Dacomitinib
Description: To evaluate the CNS efficacy of dacomitinib
Measure: CNS objective response rate (Complete response or Partial response) Time: 1 yearDescription: To evaluate the CNS efficacy of dacomitinib
Measure: CNS progression-free survival Time: 1 yearDescription: To evaluate the CNS efficacy of dacomitinib
Measure: Cumulative incidence of CNS failure by competing risk analysis Time: 1 yearDescription: To evaluate the efficacy of dacomitinib
Measure: Extracranial objective response rate Time: 1 yearDescription: To evaluate the efficacy of dacomitinib
Measure: Progression-free survival Time: 1 yearDescription: To evaluate the efficacy of dacomitinib
Measure: Overall survival Time: 1 yearDescription: To evaluate the safety of dacomitinib
Measure: Safety by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Time: 1 yearAllocation: N/A
Single Group Assignment
There are 2 SNPs
Inclusion Criteria: - Biopsy proven recurrent or metastatic NSCLC (adenocarcinoma) with major EGFR mutation (exon 19 deletion or Leu858Arg mutation without the Thr790Met) - No prior systemic treatment of advanced NSCLC (Neoadjuvant or adjuvant chemotherapy are allowed, without limitation on its treatment timing) - Age ≥20 years - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 - Had at least one measurable intracranial lesion as ≥ 5mm in the longest diameter by magnetic resonance imaging (MRI) (≥ 5mm by thin section (1.2mm) of brain MRI image, ≥ 10mm by less thin section(2.5mm) --- Leu858Arg ---
Inclusion Criteria: - Biopsy proven recurrent or metastatic NSCLC (adenocarcinoma) with major EGFR mutation (exon 19 deletion or Leu858Arg mutation without the Thr790Met) - No prior systemic treatment of advanced NSCLC (Neoadjuvant or adjuvant chemotherapy are allowed, without limitation on its treatment timing) - Age ≥20 years - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 - Had at least one measurable intracranial lesion as ≥ 5mm in the longest diameter by magnetic resonance imaging (MRI) (≥ 5mm by thin section (1.2mm) of brain MRI image, ≥ 10mm by less thin section(2.5mm) --- Leu858Arg --- --- Thr790Met ---