A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Progression Free Survival
研究概览
简要总结
This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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;
- •non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
- •ECOG PS 2;
- •adequate organ function.
排除标准
- •prior chemotherapy or systemic anti-tumor therapy;
- •hypersensitivity to erlotinib;
- •any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.
研究组 & 干预措施
Erlotinib + Gemcitabine
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
干预措施: Erlotinib (Drug)
Erlotinib + Gemcitabine
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
干预措施: Gemcitabine (Drug)
Gemcitabine
Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Up to 2 years
Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
次要结局
- Disease Control Rate(Up to 2 years)
- Objective Response Rate(Up to 2 years)
- Duration of Response(Up to 2 years)
- Overall Survival(Up to 2 years)
- Mean Change in Pulse Rate From Baseline(Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15))
- Mean Change in Blood Pressure From Baseline(Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15))
- Mean Change in Body Temperature From Baseline(Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15))