Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study
试验速览
- 阶段
- 4 期
- 入组人数
- 192
- 试验地点
- 31
- 主要终点
- Progression Free Survival
研究概览
简要总结
This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma 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
- •Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)
- •Patients must have previously untreated locally advanced or metastatic NSCLC
- •EGFR activating mutation (exon 19 deletion, L858R) is required
- •Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
排除标准
- •Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR
- •Patients with wild-type EGFR
- •Any other investigational agents are not permitted
- •Any evidence of interstitial lung disease
研究组 & 干预措施
Icotinib
Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
干预措施: Icotinib (Drug)
Sequential icotinib plus chemotherapy
Sequential icotinib plus chemotherapy : pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
干预措施: Sequential Icotinib Plus Chemotherapy (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
- Adverse events(24 months)
- Overall survival(24 months)
- Objective response rate(15 months)