Phase II, Open-Label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Percentage of Participants With Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
研究概览
简要总结
This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
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
- •Locally advanced or metastatic NSCLC with EGFR mutations
- •Measurable disease according to RECIST criteria
- •Adequate hematological, renal and liver function
排除标准
- •Previous chemotherapy or therapy against EGFR for metastatic disease
- •Symptomatic cerebral metastases
- •Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
- •History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
- •Concomitant use of coumarins
研究组 & 干预措施
Erlotinib
Participants will receive erlotinib 150 millgrams (mg) orally daily until disease progression.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
时间窗: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years])
Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
次要结局
- Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1(Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]))
- Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population(Screening (21 days prior to Day 1))
- Median Time Taken From the First Response Until Disease Progression Based on RECIST v 1.1 as Determined by the Investigator(Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]))
- Overall Survival(Baseline up to 5 years)
- Percentage of Participants With Adverse Events(Baseline up to 5 years)