NCT01836133已完成不适用
Efficacy and Safety of Erlotinib (Tarceva® ) Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) , Subtype Adenocarcinoma, Who Have Good Performance Status (PS 0-1) - ELEMENT
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult participants, >/= 18 years of age
- •Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Adequate hematologic, renal and liver function
- •Participant initiating treatment with Tarceva according to the Summary of Product Characteristics
排除标准
- •Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label
- •Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin
- •Previous systemic anti-cancer treatment with HER1/EGFR inhibitor
研究组 & 干预措施
Erlotinib 150 mg
Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
干预措施: Erlotinib 150 mg (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Approximately 3 years
PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.
次要结局
- Percentage of Participants With Overall Response(Approximately 3 years)
- Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)(Baseline up to 3 years)
研究者
研究点 (5)
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