EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 主要终点
- Progress Free Survival
研究概览
简要总结
BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.
详细描述
BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Signed informed consent
- •Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)
- •Must have measurable or non-measurable disease
- •Must be able to comply with study and follow-up procedures
排除标准
- •Small cell, carcinoid, or mixed small cell lung cancer
- •Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
- •Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC
- •Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication
- •History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
- •Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
- •Pregnancy or lactation
研究组 & 干预措施
EGFR-TK Inhibitor
Gefitinib
干预措施: EGFR-TK Inhibitor (Drug)
EGFR-TKI and Chemotherapy
gefitinib with pemetrexed/gemcitabine and carboplatin
干预措施: EGFR-TKI (Drug)
EGFR-TKI and Chemotherapy
gefitinib with pemetrexed/gemcitabine and carboplatin
干预措施: EGFR-TKI and Chemotherapy (Drug)
结局指标
主要结局
Progress Free Survival
时间窗: up to 12 months
次要结局
- Overall Survival(up to 24 months)
- Overall Response Rate(up to 12 months)
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(up to 12 months)
研究者
Caicun Zhou
Director Head of Medical Oncology, Principal Investigator, Clinical Professor
Shanghai Pulmonary Hospital, Shanghai, China