NCT02006043Unknown2 期
A Phase II, Open, Single Arm Trial to Evaluate Erlotinib Efficacy and Safety as the 2nd/3rd Line Treatment in Advanced or Recurrent NSCLC With EGFR Wild Type and Without C-met Expression
Li Zhang2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- 6 months PFS rate
研究概览
简要总结
evaluate Erlotinib efficacy and safety as the 2nd/3rd line treatment in advanced or recurrent NSCLC with EGFR wild type and without c-met expression
详细描述
In this phase II, open, single arm study, it will be evaluated of the efficacy and safety of erlotinib in 2nd/3rd line of EGFR WT and c-Met negative advanced NSCLC.The treatment goes as follows:Erlotinib 150mg/day taken orally until disease progression or intolerable toxicities.The primary end point of the study was 6 months PFS rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically or cytological documented metastatic (stage IV) or recurrent NSCLC
- •Measurable disease must be characterized according to the response evaluation criteria in solid tumors(RECIST1.1) criteria
- •Must have at least one prior platinum-based chemotherapy regimen for advanced NSCLC and now exhibit progressive disease (PD), and must have recovered from any serious treatment related toxicity
- •Neither with EGFR mutation nor c-met expression on Ventana Benchmark instrument(Met negative expression definition: ≥50% of the cells do not stain or stain with weak intensity (clinical score 0 or 1+) )
- •ECOG Performance Status 0 ~2
- •Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
- •Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN in the absence of liver metastases, or < 5 × ULN in case of liver metastases.
- •Male or female.
- •Age ≥ 18 years and ≤75 years
- •Written (signed) informed consent. Able to comply with study and follow-up procedures.
排除标准
- •Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- •Received treatment with any other investigational agent, or participated in another clinical trial, with the following exceptions.
- •Chemotherapy-only trials are permitted (if completed≧ 28 days prior to receiving the first dose of study drug).
- •Previous adjuvant or neo-adjuvant treatment for nonmetastatic disease is permitted if completed ≥ 6 months before receiving the first dose of study drug; c)Prior surgery is permitted if performed ≥ 4 weeks before receiving the first dose of study drug and the patient is fully recovered.
- •Prior localized radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed ≥ 4 weeks before receiving the first dose of study drug.
- •Participation in a methodological or observational study in which no investigational agent was given
- •Patients who have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months
- •History of another malignancy in the last 5 years with the exception of the following:
- •Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted.
- •Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- •Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient's treating oncologist and the ophthalmologist.
- •Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or that might affect the interpretation of the results or render the subject at high risk from treatment complications.
- •Female subject who is pregnant or breast-feeding
- •Any unstable systemic disease
- •Hypersensitivity to erlotinib
研究组 & 干预措施
Erlotinib 150mg/day taken orally
Experimental
Erlotinib 150mg/day taken orally until disease progression or intolerable toxicities
干预措施: Erlotinib 150mg (Drug)
结局指标
主要结局
6 months PFS rate
时间窗: at when last patient enrolled 6 months
次要结局
- overall survival, OS(at when last patient enrolled 18 months)
- objective response rate, ORR(at when last patient enrolled 18 months)
研究者
Li Zhang
Professor
Sun Yat-sen University
研究点 (2)
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