This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
601
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
30Gy/10F
Sun Yat-sen University of cancer center
Guangzhou, Guangdong, China
RECRUITINGintracranial PFS (iPFS)
Compare intracranial PFS (iPFS) of two arms
Time frame: up to 41 months
overall survival (OS)
Time frame: up to 77 months
objective response rate (ORR)
Time frame: up to 41 months
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