Efficacy and Safety of First-line mil60 Plus Paclitaxel/Carboplatin Versus Bevacizumab Plus Paclitaxel/Carboplatin in Patients With Advanced and Recurrent Non-squamous Non-small Cell Lung Cancer: a Randomized, Double-blind, Phase 3 Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 517
- 试验地点
- 2
- 主要终点
- Objective response rate
研究概览
简要总结
This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy and safety of mil60 with bevacizumab as first-line treatment when combined with standard chemotherapy (paclitaxel/carboplatin) in treatment-naive patients with advanced or recurrent non-squamous NSCLC.
详细描述
This is a multicenter, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of mil60 plus paclitaxel and carboplatin versus bevacizumab plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.The primary objective of the study was to compare the Objective Response Rate according to RECIST 1.1 of mil60 in combination with paclitaxel plus carboplatin and bevacizumab plus paclitaxel plus carboplatin in the treatment of advanced or recurrent non-squamous NSCLC subjects.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed inform consent form(ICF)
- •Aged 18-75 years, male or female
- •Histologically or cytologically documented inoperable, local advanced (stage IIIB), metastatic (stage IV), or recurrent non-squamous NSCLC
- •At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
- •Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
- •Life expectancy ≥ 12 weeks
- •Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for 6 months after receiving last study treatment
排除标准
- •Mixed non-small cell lung cancer with squamous cell carcinoma component, or small cell carcinoma
- •Patients with known Anaplastic Lymphoma Kinase（ALK） or C-Ros Oncogene 1 Receptor Tyrosine Kinase （ROS1）rearrangement
- •History of hemoptysis within 3 months prior to screening with blood volume more than 2.5 mL
- •Evidence of tumor invading major blood vessels on imaging
- •Patients with brain metastasis, spinal cord compression or carcinomatous meningitis history
- •Uncontrolled hypertension, prior history of hypertensive crisis and hypertensive encephalopathy
- •Clinically significant cardiovascular disease but not limited to active infections; unstable angina; stroke or transient cerebral ischemia; myocardial infarction; congestive heart-failure; serious cardiac arrhythmia, hepatic, renal or metabolic disease requiring medication during the study
- •History of radical radiotherapy to the thorax within 6 months
- •Serious, non-healing wound, active ulcer, or untreated bone fracture, or major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during the course of the study
- •Recent or current treatment with aspirin or other non-steroidal anti-inflammatory drugs (NSAID) known to inhibit platelet function within 10 days prior to first dose of study treatment
- •Recent or current treatment with anticoagulants or thrombolytic agent within 10 days prior to first dose of study treatment
研究组 & 干预措施
mil60
mil60 (15mg/kg) was co-administered intravenously with 4 to 6-cycle paclitaxel/carboplatin, non-progressive patients are then given with maintenance single-agent mil60 (7.5mg/kg) until disease progression, intolerable toxicity, or withdrawal.
干预措施: mil60 (Drug)
Bevacizumab
Bevacizumab (15mg/kg) was co-administered intravenously with 4 to 6-cycle paclitaxel/carboplatin, non-progressive patients are then given with maintenance single-agent mil60 (7.5mg/kg) until disease progression, intolerable toxicity, or withdrawal.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: 24 months
Percentage of patients with complete remission or partial response
次要结局
- Objective response rate(26 months)
- Duration of response(24 months)
- Overall survival(30 months)
- Progression-free survival(24 months)
- Disease control rate(24 months)