A 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
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation
研究概览
简要总结
This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Adult patients, >/=18 years of age
- •Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
- •Measurable disease according to RECIST criteria
- •ECOG performance status 0-2
- •Adequate haematological, renal and liver function
排除标准
- •Previous chemotherapy or therapy against EGFR for metastatic disease
- •History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
- •Symptomatic cerebral metastases
- •Pre-existing parenchymal lung disease such as pulmonary fibrosis
- •Concomitant use of coumarins
研究组 & 干预措施
Single Arm
干预措施: erlotinib [Tarceva] (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation
时间窗: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years
PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as \[first event date minus first dose date plus 1\] divided by 30.44.
次要结局
- Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1(Per standard of care (every 3 months) until discontinuation for up to approximately 2 years)
- Percentage of Participants Alive at 6 and 12 Months(At 6 and 12 months)
- Percentage of Participants With EGFR Mutation at Screening(Screening)
- Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants(Per standard of care (every 3 months) until discontinuation for up to approximately 2 years)