A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) as Third Line Treatment in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 13
- 主要终点
- enhanced CT/MRI scan
研究概览
简要总结
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of andvanced non-small cell lung cancer who failed two lines of chemotherapy
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
- Double (Participant, Investigator)
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
- •pathology diagnosed with advanced NSCL with measurable lesions;
- •Have failed for 2 lines of chemotherapy;
- •18-70years,ECOG PS:0-2,Life expectancy of more than 3 months;
- •Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks;
- •main organs function is normal;
- •must be agreed to take contraceptive measures during the study and within 6 months after end.
排除标准
- •SCLC(including mixed with NSCLC);
- •the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;
- •patients failed to use the anti-tumor angiogenesis therapy;
- •patients has many influence factors toward oral medications ;
- •Brain metastases patients accompanied by symptoms or symptom control for less than two months;
- •patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)>10mmol/L);urine protein≥++,etc.
- •patients failed to heal wounds or fractures for Long-term;
- •4 weeks before enrollment, patients appeared NCI CTC AE grading >1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade> 2 have other parts of the bleeding; patients has a tendency to bleed (eg active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;
- •patients occurred venous thromboembolic events within 6 months;
- •patients has HIV-positive or organ transplantation;
研究组 & 干预措施
Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Anlotinib (Drug)
Placebo Capsule
Placebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent
干预措施: Placebo capsule (Drug)
结局指标
主要结局
enhanced CT/MRI scan
时间窗: each 42 days up to disease progression
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Refer to recist 1.1.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(each 21 days up to intolerance the toxicity(or PD))