A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 43
- 主要终点
- 6-month Progression-free Survival
研究概览
简要总结
This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age >= 18
- •Histologically or cytologically documented non-small cell lung cancer (NSCLC)
- •Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
- •Radiologically measurable or evaluable disease No prior chemotherapy
- •1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
- •Tumor tissue block or fine needle aspirate
排除标准
- •Any concurrent anticancer therapy or radiation
- •Other active malignancy
- •Uncontrolled brain metastases
- •GI abnormalities
- •Severe abnormalities of the cornea
- •Significant cardiac disease
- •Active infection
研究组 & 干预措施
Erlotinib
150 mg erlotinib daily
干预措施: Tarceva (Drug)
Erlotinib + chemotherapy (intercalated)
carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
干预措施: Tarceva (Drug)
Erlotinib + chemotherapy (intercalated)
carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
干预措施: carboplatin (Drug)
Erlotinib + chemotherapy (intercalated)
carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
干预措施: paclitaxel (Drug)
结局指标
主要结局
6-month Progression-free Survival
时间窗: 6 months after first dose
Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
次要结局
- Progression-free Survival(Until time of disease progression, as assessed every 21 days (maximum 28.8 months))
- Overall Survival at 12 Months(12 months from 1st dose)
- Overall Survival(From first study treatment until time of death (maximum 29.0 months))
- Best Tumor Response(While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months))
- Duration of Tumor Response(While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).)