NCT02486354已完成3 期
Safety and Efficacy of Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy: a Single-arm, Phase 3 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 10
- 主要终点
- progression-free survival
研究概览
简要总结
This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after failure of at least one platinum-based chemotherapy regimen.
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
- •Histologically or cytologically confirmed locally advanced/metastatic (stage IIIB/stage IV, using the American Joint Committee on Cancer [AJCC] 6th edition of tumor-node-metastasis [TNM] staging system) NSCLC patients
- •Progressed after at least one platinum-based chemotherapy regimen at entry
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- •At least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0
- •Adequate hematologic and biochemical values
排除标准
- •Patients with symptomatic brain metastases
- •Malignant tumor within the previous five years
- •Severe infection; congestive heart failure
- •Previous treatment with drugs targeting EGFR
- •History of interstitial lung disease
研究组 & 干预措施
icotinib
Experimental
Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity.
干预措施: icotinib (Drug)
结局指标
主要结局
progression-free survival
时间窗: 6 months
次要结局
- overall survival(12 months)
- objective response rate(2 months)
- number of patients suffered adverse events(15 months)
研究者
研究点 (10)
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