Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The purpose of this study is to evaluate the overall response rate and disease free survival for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.
详细描述
Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung cancer whose primary tumors are too large to allow for surgery. Reduction in size of the primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover, the goals have expanded to include: determination of the sensitivity of the tumor so that subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong survival.
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
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.The patients signed the written informed consent. 2.The patients present with operable IIIAN2 non-small-cell lung cancers with 19 or 21 exon mutation.
- •3.The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, and surgical therapy.
- •4.The patients' Eastern Cooperative Oncology Group scores are ≤ 0-
- •5.The age of patient is ≥ 18 years old with a life expectancy longer than 3 months.
排除标准
- •Patients with unresected tumor.
- •Wild EGFR type.
- •Allergic to the study drug.
- •Patients have severe non-cancerous diseases.
- •Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials.
研究组 & 干预措施
Icotinib
Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.
干预措施: Icotinib (Drug)
Chemotherapy
Patients receive 8-week icotinib induction treatment before surgery and 4-cycle adjuvant chemotherapy with vinorelbine/cisplatin regimen after surgery.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Objective response rate
时间窗: 8 weeks
Disease free survival
时间窗: 1 year
次要结局
- The pathological complete response rate after neoadjuvant therapy with icotinib(8 weeks)
- The lymph node staging reduction rate of patients after neoadjuvant therapy with icotinib(8 weeks)
- The resection rate of patients after neoadjuvant therapy with icotinib(2 months)