Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Apatinib as a Single Agent in Advanced NSCLC Who Failed to at Least Two Lines Systemic Treatment, or Were Not Amendable to Receive the Second-line Standard Therapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2) and also represents mild inhibition to PDGFR, c-Kit and c-src tyrosine kinases. It is an orally bioavailable, small molecule agent which is thought to inhibit VEGF-mediated endothelial cell migration and proliferation thus blocking blood vessel formation in tumor tissues. Previous studies have identified that apatinib was well tolerated at doses below 750mg daily. In phase I/II study, investigators reported an objective response rate of 68%. In a phase III trial conducted in advanced pretreated gastric cancer, the median overall survival was significantly prolonged in the apatinib group compared with placebo group. Thus, in this trial, the investigators aim to investigate the efficacy and safety of apatinib in previously treated advanced non-squamous non-small cell lung cancer.
详细描述
Observing the efficacy and safety of apatinib in heavily treated non-squamous non-small cell lung cancer.
Primary Outcome Measure: Objective Response Rate Secondary Outcome Measures: Progression free survival, overall survival, Side effects, Quality Of Life
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obtain of informed consent.
- •Aged 18 years and over.
- •Histologically or cytologically confirmed non-squamous non-small cell lung cancer.
- •World Health Organization (WHO) performance status (PS) of 0 to
- •Measurable lesions as defined by RECIST criteria.
- •Life expectancy ≥12 weeks.
- •Progressed after at least two lines systemic treatment, or were not amendable to receive the current standard therapy
- •Organ functions normal, as defined below, within two weeks of randomization: Hb≥90g/L Absolute neutrophils count(ANC)≥1.5×109/L Platelets≥80×109/L Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT)≤2.5×ULN(≤5×ULN if liver metastases) Creatinine clearance≥45ml/min or Cr≤1.25×ULN
- •Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.
排除标准
- •Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
- •Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
- •Tumor invade big vessels or close to big vessels (less than 5mm)
- •Obvious cavity or necrosis formed in the tumor
- •Uncontrolled hypertension
- •Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
- •Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy
- •Hemoptysis, more than 2.5ml daily
- •Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
- •Unhealed bone fracture or wound for long time
- •Received big surgery, had bone fracture or ulcer in 4 weeks.
- •Urine protein≥++, or urine protein in 24 hours≥1.0g
- •Pregnant or lactating woman.
研究组 & 干预措施
apatinib single agent
apatinib, single agent, 500mg or 750mg Qd po, continue until disease progression
干预措施: apatinib single agent (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: tumor assessment every 2 cycles after the initiation of apatinib，up to 24 months
To evaluate Objective response rate every 6-8 weeks after the initiation of apatinib.
次要结局
- Progression free survival(12 months)
研究者
Caicun Zhou
Pro, Dr
Tongji University