Open Label Study of Erlotinib (Tarceva®) as Single Agent First Line Treatment of Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With Activating Epidermal Growth Factor Receptor (EGFR) Mutations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating 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
- •Histologically or cytologically documented, inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
- •Non-small cell lung cancer with an EGFR activating mutation
- •Patients must have evidence of disease, but measurable disease is not mandatory
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate renal and liver function
排除标准
- •Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed if completed within 6 months prior to enrolment. Prior radiochemotherapy is allowed if completed more than 6 months before start of study treatment
- •Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
- •Any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
- •Brain metastasis or spinal cord compression not yet definitely treated with surgery and/or radiation
- •Patients unable to take oral medication or requiring intravenous alimentation, with prior surgical procedures affecting absorption or active peptic ulcer disease
- •Any significant ophthalmologic abnormality, especially those likely to increase the risk of corneal epithelial lesions; the use of contact lenses is not recommended during the study
- •Pregnant or breast-feeding women
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)
时间窗: Baseline to progressive disease or death (up to 34 months)
PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours \[RECIST\] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology.
次要结局
- Percentage of Participants With Best Overall Response (BOR)(Baseline to progressive disease or death (up to 34 months))
- Percentage of Participants Who Were Alive at 1 Year(1 Year (12 months))