An Open-label, Randomized, Multicenter, Phase II Trial to Evaluate the Safety and Efficacy of Dose Escalation of Icotinib in Advanced or Metastatic NSCLC Patients After 8 Weeks Routine Therapy Evaluated as Stable Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 180
- 试验地点
- 17
- 主要终点
- Progression Free Survival
研究概览
简要总结
The primary purposes of this study are to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy.
详细描述
This is a multi-center phase II randomized controlled study to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS, as well as OS and DCR. The adverse events and adverse reaction are evaluated as well.
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
- •Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
- •No previous targeted treatment such as gefitinib, erlotinib.
- •With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) at least according to RECIST Criteria
- •WHO performance status(PS)<= 2
- •N>=1.5×109/L, Plt>=1.0×109/L,Hb>=10g/dL;AST&ALT should <3ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
- •Signed and dated informed consent before the start of specific protocol procedures.
排除标准
- •Allergic to icotinib
- •Patients with metastatic brain tumors with symptoms.
- •Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
- •Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
研究组 & 干预措施
Icotinib of Routine Dose
Oral Drug icotinib 125 mg three times per day
干预措施: Icotinib of routine dose (Drug)
Icotinib of High Dose
Oral Drug icotinib 250 mg three times per day
干预措施: Icotinib of high dose (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 6 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(15 months)
- Transformation rate from stable disease to complete response or partial response(6 weeks)
- Incidence rate of adverse events(40 months)