NCT01372384已完成2 期
Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced, Metastatic or Recurrent Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Progression-free Survival (Tumour Assessments According to RECIST Criteria)
研究概览
简要总结
This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.
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
- •Adult patients, >/= 18 years of age
- •Locally advanced (Stage IIIB), metastatic (Stage IV) or recurrent non-small cell lung cancer with mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR)
- •At least one measurable lesion according to RECIST criteria
- •European Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate hematological, liver and renal function
- •Patients with stable cerebral metastases who have received surgical or radiotherapy will be eligible
排除标准
- •Previous chemotherapy or therapy against EGFR for metastatic disease (neoadjuvant or adjuvant therapy after radical surgery is allowed if finalized >/= 6 months before entering the study)
- •History of another neoplasm except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, radically treated prostate carcinoma with good prognosis (Gleason </= 6), or another curatively treated neoplasm without evidence of disease in the last 5 years
- •Symptomatic cerebral metastases
- •Any significant ophthalmologic abnormality
- •Use of coumarins
- •Pregnant or breast-feeding women
- •Pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and carcinomatosis (if this is the only presence of the disease)
研究组 & 干预措施
Single Arm
Experimental
干预措施: erlotinib [Tarceva] (Drug)
结局指标
主要结局
Progression-free Survival (Tumour Assessments According to RECIST Criteria)
时间窗: Until participants had disease progression, unacceptable toxicity or died; approximately 24 months.
Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death.
次要结局
- Objective Response Rate (Investigator Assessed)(Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months))
- Safety: Incidence of Adverse Events(Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.)
- Overall Survival(Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.)
研究者
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