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ACTIVE NOT RECRUITING
NCT03866499
PHASE3

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

Sponsor: Beta Pharma Shanghai

View on ClinicalTrials.gov

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

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

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