NCT03904823Unknown2 期
An Open, Single-arm, Multi-center, Phase 2 Clinical Trial of Famitinib Combined With Epidermal Growth Factor Receptor (EGFR) Inhibitor HS-10296 in Patients With Advanced EGFR-mutant Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety and tolerability of famitinib combined with HS-10296 in subjects with advanced EGFR-mutant NSCLC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's written informed consent obtained prior to any process, sampling, or analysis related to the study.
- •Male or female, no less than 18 years old.
- •Confirmed as NSCLC by histology or cytology.
- •Locally advanced or metastatic NSCLC and not suitable for radical surgery or radiotherapy.
- •Have not received EGFR Tyrosine Kinase Inhibitor (TKI) therapy.
- •At least one baseline tumor lesion.
- •Can swallow pills normally.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0~1 points, expected survival≥12 weeks.
- •Adequate organ function.
排除标准
- •Clinically symptomatic central nervous system metastases.
- •Ascites, pleural effusion or pericardial effusion with clinical symptoms.
- •Other malignant tumors in the past 5 years or at the same time.
- •High blood pressure which are not well controlled.
- •Heart disease that are not well controlled.
- •Coagulation dysfunction, bleeding tendency or receiving thrombolysis or anticoagulant therapy.
- •History of bleeding.
- •Known hereditary or acquired bleeding and thrombophilia.
- •Any serious or uncontrolled ocular lesion.
- •Interstitial lung disease or non-infectious pneumonia treated with corticosteroids.
- •Congenital or acquired immunodeficiency.
- •Other factors that may affect the results of the study or cause the study to be terminated midway.
研究组 & 干预措施
famitinib, HS-10296
Experimental
干预措施: famitinib po (Drug)
famitinib, HS-10296
Experimental
干预措施: HS-10296 po (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
次要结局
- Disease Control Rate (DCR)(From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Clinical Benefit Ratio (CBR)(From the start of treatment to 6 months)
- Duration of Response (DOR)(From the first partial response or complete response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- 12-month-PFS(From the start of treatment to 12 months)
- Rate of Adverse Events and Serious Adverse Events(From the first drug administration to within 30 days after the last dose)
- Number of Participants with Clinically significant toxicity(First cycle (21 days))
- Depth of Response (DepOR)(From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Progression-Free-Survival (PFS)(up to 2 years)
研究者
研究点 (1)
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