Phase II, 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 (EGFR) - (TRIGGER)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Disease Progression or Death at 12 Months After Baseline
研究概览
简要总结
This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.
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 or metastatic non-small cell lung cancer
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Life expectancy over >/=12 weeks
- •Adequate hematological, liver, or kidney function
排除标准
- •Previous therapy against epidermal growth factor receptor for metastatic disease
- •Treatment with investigational drug during the 3 weeks before enrollment
- •History of neoplasm
- •Patients with symptomatic cerebral metastases
- •Unstable systemic disease
研究组 & 干预措施
Single Arm
干预措施: erlotinib (Drug)
结局指标
主要结局
Percentage of Participants With Disease Progression or Death at 12 Months After Baseline
时间窗: 12 months
According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Progression-Free Survival (PFS)
时间窗: Up to 1 year after enrollment of the last participant (maximum up to 27 months)
PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method.
Probability of Being Progression Free 12 Months After Baseline
时间窗: 12 months
According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
次要结局
- Percentage of Participants Who Died(Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months))
- Overall Survival (OS)(Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months))
- Percentage of Participants With a Response by Best Overall Response(Baseline up to disease progression or end of study (up to 12 Months))
- Percentage of Participants With Objective Response(Baseline up to disease progression or end of study (up to 12 Months))
- Percentage of Participants Achieving CR, PR, or SD as Best Overall Response(Baseline up to disease progression or end of study (up to 12 Months))
- Percentage of Participants With Primary and Secondary Resistance(Baseline up to disease progression (up to 12 Months))
- Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type(Baseline, At progression of disease (up to 12 Months))