Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Untreated Advanced Non-small-cell Lung Cancer: a Randomized, Open-label Study
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer patients with EGFR mutation.
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
- •Stage IV or IIIB advanced non-small cell lung cancer patients
- •Positive EGFR Mutation
- •Non-progressive disease after first-line gemcitabine/cisplatin therapy
- •Measurable lesion according to RECIST 1.1 with at least one measurable lesion
排除标准
- •Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
- •Patients with wild-type EGFR
- •Evidence of interstitial lung diseases
- •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
Sequential and maintenance icotinib
Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
干预措施: Sequential and maintenance icotinib (Drug)
Maintenance icotinib
Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib (125 mg three times per day) as maintenance treatment until disease progression or intolerable toxicity.
干预措施: Maintenance icotinib (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 15 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
- Overall survival(24 months)
- Objective response rate(24 months)
- Disease control rate (DCR)(24 months)
- Adverse events(24 months)