NCT03866499

A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Beta Pharma Shanghai · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	BPI-7711	180 mg, oral, QD
DRUG	Gefitinib	250 mg, oral, QD
DRUG	Placebo Tablet	250 mg gefitinib placebo tablet, QD
DRUG	Placebo capsule	180 mg BPI-7711 placebo capsule, QD

Timeline

• Start date: 2021-04-30
• Primary completion: 2023-11-30
• Completion: 2025-12-30
• First posted: 2019-03-07
• Last updated: 2024-08-07

Locations

3 sites across 1 country: China