An Open-label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-small Cell Lung Cancer Who Have Experienced Disease Progression During Platinum-based Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 424
- 主要终点
- Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)
研究概览
简要总结
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 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;
- •histologically documented, locally advanced or recurrent or metastatic NSCLC;
- •measurable disease;
- •disease progression during 1-4 cycles of platinum-based chemotherapy.
排除标准
- •any other malignancies within the last 5 years;
- •unstable systemic disease.
研究组 & 干预措施
1
干预措施: erlotinib [Tarceva] (Drug)
2
干预措施: Alimta or Taxotere (Drug)
结局指标
主要结局
Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)
时间窗: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months
Overall survival (OS) was determined from the date of randomization to the date of death irrespective of the cause of death.
Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)
时间窗: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.
Probable Percentage of Participants Remaining Alive at 1 Year
时间窗: 1 Year
OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.
次要结局
- Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months)
- Duration of OS in EGFR Positive and Negative Population(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months)
- Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population(1 Year)
- Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months)
- Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months)
- Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months(6 Months)
- Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months)
- PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months)
- Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population(6 Months)
- Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Death or up to 52 months)
- Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months)
- Time to Deterioration in Quality of Life Using FACT-L(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months)
- Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L(6 Months)
- Percentage of Participants With Symptomatic Progression Using FACT-L(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months)
- Time to Symptomatic Progression Using FACT-L(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months)
- Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L(6 Months)
- Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months)
- Time to Deterioration in the TOI(Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months)
- Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L(6 Months)