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

Phase 3

Active, not recruiting

• Conditions: NSCLC
• Interventions: Drug: BPI-7711; Drug: Gefitinib; Drug: Placebo Tablet; Drug: Placebo capsule

• Registration Number: NCT03866499
• Lead Sponsor: Beta Pharma Shanghai

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-07
• Study Start: 2021-04-30
• Primary Completion: 2023-11-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 369

Inclusion Criteria

• Histologically or cytologically confirmed non-small cell lung cancer.
• The ECOG score of performance status is 0-1.
• Locally advanced or recurrent metastatic NSCLC that has never received systemic treatment.
• According to RECIST1.1 criteria, there is at least 1 measurable lesion that has not been previously irradiated.
• Prior to enrollment, a central laboratory testing report has confirmed that the tumor has one of two common EGFR mutations positive that are sensitive to EGFR-TKI therapy, accompanied with or not accompanied with other EGFR mutation, with the exception of exon 20 insertion.

Exclusion Criteria

• Previously received systemic treatment for locally advanced or recurrent metastatic cancer.
• Primary T790M mutation-positive patient.
• Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring hormonal therapy, or any clinically proven active interstitial lung disease.
• Known active infections such as hepatitis B, hepatitis C, and human immunodeficiency virus.
• Local radiation therapy is carried out within 1 week; more than 30% bone marrow radiation therapy or extensive radiation therapy is performed within 4 weeks.
• ≤ 4 weeks from major surgery or ≤ 2 weeks from minor surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPI-7711	BPI-7711	180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD
BPI-7711	Placebo Tablet	180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD
Gefitinib	Gefitinib	180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD
Gefitinib	Placebo capsule	180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD

Primary Outcome Measures

Name	Time	Method
Progression-free survival	up to approximately 16 months	Progression-free survival evaluated by Blinded Independent Center Review

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	up to approximately 16 months	Progression-free survival evaluated by investigators
Objective response rate	up to approximately 16 months	Objective response rate
Best objective response	up to approximately 16 months	Best objective response
Disease control rate	up to approximately 16 months	Disease control rate
Duration of response	up to approximately 16 months	Duration of response
Overall survival	up to approximately 30 months	Overall survival

Trial Locations

Locations (3)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Linyi Cancer Hospital; 🇨🇳 Linyi, Shandong, China