An Open-label, Single-armed Pilot Study to Evaluate the Efficacy of Icotinib in Previously Treated Non/Light-smoking Patients With Squamous Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study is designed to evaluate the efficacy of icotinib at routine dose in previously treated non/light-smoking patients with advanced squamous cell lung cancer.
详细描述
This study is designed to evaluate the efficacy of icotinib at routine dose in previously treated non/light-smoking patients with advanced squamous cell lung cancer. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, confirmed at least 28 days following the date of the initial response.
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
- 否
入选标准
- •Histologically or cytologically confirmed metastatic or recurrent squamous cell lung cancer from the primary lesion and/or lymph nodes, stage IIIB or IV patients with non-smoking or light-smoking history.
- •Failure of at least 1, and no more than 2, prior chemotherapy regimens for advanced disease (either due to progressive disease or toxicity).
- •Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan.
- •Be >= 18 years of age.
- •Expected survival period over 12 weeks;
- •ECOG PS 0-
- •Adequate organ system function as defined within the protocol.
- •Patients with a history of CNS metastases or cord compression are allowed if they have been definitively treated and are clinically stable.
- •Consent compliance research plan and follow-up process, and be able to carry out oral therapy; Provision of written informed consent.
- •In women of childbearing age, must be in before starting treatment within 7 day of urine pregnancy test and the result is negative, and not in the lactation period, and reproductive age men and women prior to entry into the study, the research process until 90 days after stopping all agree to use reliable methods of contraception;
- •Weight loss =< 10% in past 6 months.
- •Adequate tumor tissue for detection of molecular biomarkers.
排除标准
- •Patients who have previously received treatment with EGFR-TKIs.
- •Concomitant treatment with any other experimental drug under investigation or anti-tumor therapy;
- •Symptomatic CNS metastases or newly diagnosed CNS metastases that have not yet been definitively treated with radiation and/or surgery.
- •Known severe hypersensitivity to icotinib or any of the excipients of this product.
- •Presence of uncontrolled pleural effusion or/and peritoneal effusion;
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
- •Past or current history of neoplasm (other than the entry diagnosis) in past 5 years, with the exception of treated basal cell carcinoma or carcinoma in situ of the cervix, or other cancers cured by local therapy alone.
- •Women who are lactating.or have positive pregnancy test.
研究组 & 干预措施
one arm
Icotinib of routine dose Icotinib: 125mg, oral administration, three times per day.
干预措施: Icotinib (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 4 Weeks
Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, confirmed at least 28 days following the date of the initial response.
次要结局
- Number of Participants with Adverse Events(3 months)
- Progression free survival(3 months)
- Overall survival(14 months)
研究者
Qiong Zhao
Prof.
Zhejiang University