NCT04211896Unknown2 期
The Efficacy and Safety of Anlotinib Combined With Nivolumab as a Second-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This study evaluates the safety and efficacy of anlotinib in combination with nivilumab as second-line treatment in advanced NSCLC patients. The primary endpoint of the study is progression-free survival (PFS);the secondary endpoints are disease control rate (DCR), objective response rate (ORR), overall survival (OS) and safety.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18-75 years old;
- •ECOG PS：0-1,Expected Survival Time: Over 3 months;
- •Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC, with measurable nidus(using RECIST 1.1);
- •For local advanced or advanced NSCLC, disease progression occurred after first-line systemic treatment previously;
- •The negative patients in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs;
- •main organs function is normal;
- •Signed and dated informed consent.
排除标准
- •have used Anlotinib before;
- •Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer);
- •examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs;
- •Previously (within 5 years) or presently suffering from other malignancies;
- •Symptomatic or uncontrolled brain metastases;
- •Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication;
- •Pregnancy or lactation.
研究组 & 干预措施
anlotinib plus nivolumab
Experimental
干预措施: Anlotinib (Drug)
anlotinib plus nivolumab
Experimental
干预措施: Nivolumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 6 months
PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Until 30 day safety follow-up visit)
- Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 12 months))
- Disease control rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 12 months))
- Overall Survival (OS)(12 months)
研究者
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