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
Overview
- Phase
- Phase 3
- Intervention
- BPI-7711
- Conditions
- NSCLC
- Sponsor
- Beta Pharma Shanghai
- Enrollment
- 369
- Locations
- 3
- Primary Endpoint
- Progression-free survival
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed non-small cell lung cancer.
- •The ECOG score of performance status is 0-
- •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.
Arms & Interventions
BPI-7711
180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD
Intervention: BPI-7711
BPI-7711
180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD
Intervention: Placebo Tablet
Gefitinib
180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD
Intervention: Gefitinib
Gefitinib
180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD
Intervention: Placebo capsule
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: up to approximately 16 months
Progression-free survival evaluated by Blinded Independent Center Review
Secondary Outcomes
- Progression-free survival(up to approximately 16 months)
- Objective response rate(up to approximately 16 months)
- Best objective response(up to approximately 16 months)
- Disease control rate(up to approximately 16 months)
- Duration of response(up to approximately 16 months)
- Overall survival(up to approximately 30 months)