Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer:a Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present phase III trial, the investigators will further evaluate the efficacy and toxicities of apatinib in the treatment of advanced non-squamous non-small cell lung cancer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 to 70 years of age
- •Documented pathological evidence of advanced non-squamous non-small cell lung cancer with measurable lesions
- •Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and second-line or more regimens of chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1
- •Patients had to have recovered from any toxic effects of therapy
- •Patients with brain/meninges metastasis should keep stable disease for 2 months before randomisation
- •Adequate hematologic and biochemical values were required
排除标准
- •Presence of small-cell lung cancer alone or with NSCLC
- •Pregnant or breast-feeding women
- •Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure > 140 mmHg，diastolic pressure > 90 mmHg), cardiac ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac insufficiency
- •Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction)
- •Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy
- •≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks
- •Bone fracture or wounds that was not cured for a long time
- •Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents
- •Mental diseases and psychotropic substances abuse
- •Previous treatment with an experimental agent within 4 weeks
- •Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS
- •Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in situ of uterine cervix)
研究组 & 干预措施
Apatinib
750 mg，po，QD； 28 days every cycle
干预措施: apatinib (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 24 months
Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.
次要结局
- Objective Response Rate(ORR)(24 months)
- Overall Survival(OS)(24 months)
- Toxicity(24 months)
研究者
Li Zhang
Professor
Sun Yat-sen University