Phase IIIb, Open-Label 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
- 3 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 4
- 主要终点
- Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)
研究概览
简要总结
This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
- •Measurable disease according to RECIST
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Life expectancy greater than or equal to (>/=) 12 weeks
- •Adequate hematological, liver and renal function
- •Participants with asymptomatic and stable cerebral metastases receiving medical treatment
排除标准
- •Previous chemotherapy or treatment against EGFR for metastatic disease
- •Treatment with an investigational agent less than 3 weeks before enrollment
- •History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
- •Participants with symptomatic cerebral metastases
- •Any significant ophthalmologic abnormality
- •Unstable systemic disease
- •Coumarins use
- •Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
- •Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
- •Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
研究组 & 干预措施
Erlotinib
Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)
时间窗: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact.
次要结局
- Proportion of Participants With Objective Response as Assessed by RECIST v 1.1(Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months))
- Proportion of Participants With Disease Control as Assessed by RECIST v 1.1(Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months))
- Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations(Screening up to approximately 7 days)
- Percentage of Participants With Adverse Events(Baseline up to approximately 4 years and 9 months)
- Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L)(Baseline and end of study (approximately 4 years and 9 months))