Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 296
- 试验地点
- 21
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.
详细描述
This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
- •Positive EGFR Mutation.
- •No previous systemic anticancer therapy.
- •Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
- •Provision of written informed consent.
排除标准
- •Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
- •Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
- •Known severe hypersensitivity to icotinib or any of the excipients of this product.
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
研究组 & 干预措施
Icotinib
Icotinib 125mg is administered orally three times per day.
干预措施: Icotinib (Drug)
Chemotherapy
Patients in this arm will receive pemetrexed/cisplatin for 4 cycles, of who don't progress will receive maintenance treatment with pemetrexed.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 12 months
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
次要结局
- Objective response rate(12 weeks)
- Overall survival(20 months)