A Randomized, Controlled Phase III Trial to Evaluate the Efficacy of Elortinib vs Gefitinib in Advanced Non-small-cell Lung Cancer With EGFR Exon 19 or 21 Mutations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was progression-free survival (PFS).
详细描述
Patients with stage IV NSCLC who have EGFR exon 19 or 21 mutations will randomized to received oral erlotinib 150mg or gefitinib 250mg once daily until disease progression or unacceptable toxicity. Method of direct DNA sequencing of tumor tissue is used to analysis EGFR mutation status of exons 18-21. The response will be evaluated by RECIST criteria first month,second month and then repeat every 3 months after the beginning of the treatment weeks.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed stage IIIB (wet) or IV NSCLC.
- •Patients with positive EGFR exon19 or exon21 mutation as confirmed by direct sequencing histologically.
- •Signing the informed consent form.
- •The vital organ functions are tolerant to therapy.
- •Have recovered to CTCAE2 grade below from toxicity of previous chemotherapy and radiotherapy
- •PS 0-2 scores.
- •Functional reserve of bone marrow is adequate, e.g. white blood cell count ≥3.0×109/L, planet count ≥90×109/L, and HB≥80×109/L.
- •Serum bilirubin is 2 times less than the upper limit of normal (ULN), ALT and AST are 3 times less than ULN; for liver metastases, ALT and AST need to be 5 times less than ULN; creatinine should be 2 times less than ULN.
排除标准
- •Informed consent is not provided.
- •Women of pregnancy or breastfeeding.
- •Have difficulty in swallowing.
研究组 & 干预措施
erlotinib
erlotinib 150 mg oral till disease progression
干预措施: erlotinib (Drug)
gefitinib
gefitinib 250mg oral till disease progression.
干预措施: gefitinib (Drug)
结局指标
主要结局
progression-free survival
时间窗: two years
次要结局
- Safety events(two years)
- Pharmacoeconomic(two years)
- overall survival(three years)
- Response rate(one year)
研究者
Yi-Long Wu
Professor
Chinese Society of Lung Cancer