MERIT - A Phase II Marker Identification Trial for Tarceva in Second Line NSCLC Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 264
- 主要终点
- Number of Differentially Expressed Genes Associated With Clinical Benefit
研究概览
简要总结
This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death.
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
- •Advanced NSCLC
- •Tumor accessible for biopsy by bronchoscopy
- •Disease progression following course of standard chemotherapy, or participants unwilling/unable to undergo chemotherapy
排除标准
- •Unstable systemic disease
- •Any other malignancies in the last 5 years
- •Brain metastases
- •Previous treatment with therapy acting on the epidermal growth factor receptor (EGFR) axis
研究组 & 干预措施
Erlotinib
Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Number of Differentially Expressed Genes Associated With Clinical Benefit
时间窗: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Clinical benefit is defined in the Outcome Measure 5.
Number of KRAS Mutation Participants Who Achieved Clinical Benefit
时间窗: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with KRAS gene mutation and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.
Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit
时间窗: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.
次要结局
- Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST(Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years)
- Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST)(Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years)