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
Name: BPI-7711
Description: 180 mg, oral, QDType: DrugBPI-7711
Name: Gefitinib
Description: 250 mg, oral, QDType: DrugGefitinib
Name: Placebo Tablet
Description: 250 mg gefitinib placebo tablet, QDType: DrugBPI-7711
Name: Placebo capsule
Description: 180 mg BPI-7711 placebo capsule, QDType: DrugGefitinib
Description: Progression-free survival evaluated by Blinded Independent Center Review
Measure: Progression-free survival Time: up to approximately 16 monthsDescription: Progression-free survival evaluated by investigators
Measure: Progression-free survival Time: up to approximately 16 monthsDescription: Objective response rate
Measure: Objective response rate Time: up to approximately 16 monthsDescription: Best objective response
Measure: Best objective response Time: up to approximately 16 monthsDescription: Disease control rate
Measure: Disease control rate Time: up to approximately 16 monthsDescription: Duration of response
Measure: Duration of response Time: up to approximately 16 monthsDescription: Overall survival
Measure: Overall survival Time: up to approximately 30 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
- Primary T790M mutation-positive patient. --- T790M ---