A randomized, double-blind, positive controlled phase III study to evaluate the efficacy and safety of BPI-7711 capsule in locally advanced or recurrent/metastatic treatment-naïve non-small cell lung cancer patients with EGFR mutation
This is a Phase III clinical study, which aims to compare the efficacy and safety of BPI-7711 capsule and gefitinib tablet in the treatment of initially-treated patients with locally advanced or recurrent metastatic with EGFR mutation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
369
180 mg, oral, QD
250 mg, oral, QD
250 mg gefitinib placebo tablet, QD
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Linyi Cancer Hospital
Linyi, Shandong, China
Progression-free survival
Progression-free survival evaluated by Blinded Independent Center Review
Time frame: up to approximately 16 months
Progression-free survival
Progression-free survival evaluated by investigators
Time frame: up to approximately 16 months
Objective response rate
Objective response rate
Time frame: up to approximately 16 months
Best objective response
Best objective response
Time frame: up to approximately 16 months
Disease control rate
Disease control rate
Time frame: up to approximately 16 months
Duration of response
Duration of response
Time frame: up to approximately 16 months
Overall survival
Overall survival
Time frame: up to approximately 30 months
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180 mg BPI-7711 placebo capsule, QD