Fruquintinib in Combination With Gefitinib as First-line Therapy in Patients With Advanced Non-squamous Non-small-cell Lung Cancer Harboring Activating EGFR Mutations : a Single-arm, Multicenter, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm, multicenter, phase II study
详细描述
This phase II trial will evaluate the combination of fruquintinib and gefitinib in advanced NSCLC. The endpoint will be to evaluate the efficacy and safety of the combination.
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
- •Signed Informed Consent Form.
- •Age between 18 to 75 years old.
- •Histologically or cytological documented stage IIIB/IV non-squamous non-small cell lung cancer patients who have never received systematic treatment for the late-stage disease.
- •Patients must have measurable lesions
排除标准
- •Prior systematic treatment for the advanced NSCLC
- •Absolute neutrophil count (ANC) < 1.5×10^9 /L, or platelet count < 100 ×10^9/L, or hemoglobin < 9 g/dL
- •Total bilirubin > 1 ULN; SGOT (AST), SGPT (ALT), > 1.5 ULN; for patient with liver metastasis，AST or ALT > 3 ULN
- •Known HIV positive
- •Hypersensitivity to either of the investigation drugs
研究组 & 干预措施
Fruquintinib & Gefitinib
Drug: Fruquintinib and Gefitinib
干预措施: Fruquintinib (Drug)
Fruquintinib & Gefitinib
Drug: Fruquintinib and Gefitinib
干预措施: Gefitinib (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: Each patient will be followed for 30 days after the last dose
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
tumor objective response rate
时间窗: Patients will be followed until study completion, an average of 1 year
Occurrence of completed response or partial response after treatment, assessed by RECIST 1.1
次要结局
- Progression-free survival (PFS)(Patients will be followed until study completion, an average of 1 year)
- Time to response (TTR)(Patients will be followed until study completion, an average of 1 year)
- Duration control rate (DCR)(Patients will be followed until study completion, an average of 1 year)
- Duration of response （DoR）(Patients will be followed until study completion, an average of 1 year)