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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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NSCLC

Intervention / Treatment
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* Drug: BPI-7711
* Drug: Gefitinib
* Drug: Placebo Tablet
* Drug: Placebo capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPI-7711<br>180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD | Drug: BPI-7711<br>* 180 mg, oral, QD<br>* Other names: BPI-7711 capsule;Drug: Placebo Tablet<br>* 250 mg gefitinib placebo tablet, QD<br>* Other names: placebo;|
| Active Comparator: Gefitinib<br>180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD | Drug: Gefitinib<br>* 250 mg, oral, QD<br>* Other names: Iressa;Drug: Placebo capsule<br>* 180 mg BPI-7711 placebo capsule, QD<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival evaluated by Blinded Independent Center Review | up to approximately 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival evaluated by investigators | up to approximately 16 months | 
| Objective response rate | Objective response rate | up to approximately 16 months | 
| Best objective response | Best objective response | up to approximately 16 months | 
| Disease control rate | Disease control rate | up to approximately 16 months | 
| Duration of response | Duration of response | up to approximately 16 months | 
| Overall survival | Overall survival | up to approximately 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGFR mutation, EGFR TKI, NSCLC