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A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
Sponsor: Beta Pharma Shanghai
Summary
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
369
Start Date
2021-04-30
Completion Date
2025-12-30
Last Updated
2024-08-07
Healthy Volunteers
No
Conditions
Interventions
BPI-7711
180 mg, oral, QD
Gefitinib
250 mg, oral, QD
Placebo Tablet
250 mg gefitinib placebo tablet, QD
Placebo capsule
180 mg BPI-7711 placebo capsule, QD
Locations (3)
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