A Single Arm, One Center, Phase Ⅱ Study of Erlotinib as Neoadjuvent Treatment in Patients With Endobronchial Ultrasound Confirmed Stage ⅢA N2 NSCLC With EGFR Mutation in Exon 19 or 21
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- radical resection rate
研究概览
简要总结
This is a single arm, one center, phaseⅡ study evaluating efficacy and safety of erlotinib as neoadjuvent treatment in patients with EBUS confirmed stage ⅢA N2 NSCLC with activating EGFR mutation in exon 19 or 21.
详细描述
Screening phase:
Patients clinically diagnosed as stage ⅢA N2 lung caner by CT technique will be pathologically proven as NSCLC with N2 by EBUS. The pathology specimen will be detected EGFR mutation by DNA sequencing. The patients with EGFR mutation in exon 19 or 21 will be enrolled in this study.
Neoadjuvant treatment phase:
Patient will receive erlotinib 150mg/day. Treatment will be scheduled to continue for a total of 8 weeks or disease progression or unacceptable toxicities.
Surgery treatment phase:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent provided. Males or females aged ≥18 years. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- •Stage IIIA N2 NSCLC according to the pathological evidence of endobronchial ultrasound(EBUS).
- •The biopsy specimen shows EGFR mutation in exon 19 or 21 by DNA sequencing. Measurable disease must be characterized according to RECIST criteria: measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20cm with conventional techniques (PE, CT, XR, MRI) or as ≥ 10cm with spiral scan.
- •ECOG performance status 0-
- •Life expectancy ≥12 weeks.
- •Female subjects should not be pregnant or breast-feeding.
排除标准
- •The biopsy specimen shows EGFR wildtype in exon 19 or 21 by DNA sequencing. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- •Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
- •Known hypersensitivity to Tarceva or any of its recipients.
- •Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.
- •Sexually active males and females(of childbearing potential) unwilling to practice contraception during the study.
研究组 & 干预措施
Erlotinib
Single-arm
干预措施: erlotinib (Drug)
结局指标
主要结局
radical resection rate
时间窗: operation after effective neoadjuvant treatment of tarceva for 56 days
To evaluate radical resection rate of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
次要结局
- Objective Response Rate(Objective Response Rate measured by RECIST criteria in ITT population treated by erlotinib)
- safety profile(For all the patient accepted study treatment)
- explorative biomarkers(During study conduction period)
- Pathological Complete Remission(operation after effective neoadjuvant treatment of tarceva for 56 days)
- overall survival(From study treatment to death due to any cause)
- disease free survival(From surgery to disease relapse or death)
- quality of life(During study treatment period)
研究者
Baohui Han
Vice President
Shanghai Chest Hospital