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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 369
- 试验地点
- 3
- 主要终点
- Progression-free survival
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
BPI-7711
180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD
干预措施: BPI-7711 (Drug)
BPI-7711
180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD
干预措施: Placebo Tablet (Drug)
Gefitinib
180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD
干预措施: Gefitinib (Drug)
Gefitinib
180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD
干预措施: Placebo capsule (Drug)
结局指标
主要结局
Progression-free survival
时间窗: up to approximately 16 months
Progression-free survival evaluated by Blinded Independent Center Review
次要结局
- 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)