A Randomized, Placebo-controlled, Double-blind Phase III Study of the Effect of First-line Treatment With Intercalated Tarceva Versus Placebo in Combination With Gemcitabine/Platinum on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 451
- 主要终点
- Median Progression Free Survival (PFS) Time
研究概览
简要总结
This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo 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
- Double (Participant, Investigator)
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;
- •advanced (stage IIIB/IV)non-small cell lung cancer;
- •measurable disease;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
排除标准
- •prior exposure to agents directed at the HER axis;
- •prior chemotherapy or systemic anti-tumor therapy after advanced disease;
- •unstable systemic disease;
- •any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
- •brain metastasis or spinal cord compression.
研究组 & 干预措施
1
干预措施: Platinum chemotherapy (cisplatin or carboplatin) (Drug)
1
干预措施: erlotinib [Tarceva] (Drug)
1
干预措施: gemcitabine (Drug)
2
干预措施: Placebo (Drug)
2
干预措施: Platinum chemotherapy (cisplatin or carboplatin) (Drug)
2
干预措施: gemcitabine (Drug)
结局指标
主要结局
Median Progression Free Survival (PFS) Time
时间窗: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])
Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. Analysis was performed using Kaplan-Meier method.
次要结局
- Percentage of Participants Alive and Free From Disease Progression(Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]))
- Median PFS Time Based on Different Subgroups(Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]))
- Median Overall Survival (OS) Time-Overall and Among Different Subgroups(Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years]))
- Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups(Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years]))
- Non-Progression Rate: Percentage of Participants With a Confirmed Best Overall Response of Either Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for At Least 16 Weeks(Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]))
- Objective Response Rate: Percentage of Participants With a Confirmed Best Overall Response of CR or PR(Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]))
- Duration of Response(Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]))
- Time to Progression(Randomization until PD (assessed at baseline and every 8 weeks thereafter until PD or end of study [up to approximately 1.5 years]))
- Percentage of Participants With Symptomatic Progression Assessed Using the Lung Cancer Subscale (LCS)(Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years))
- Time to Symptomatic Progression(Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years))
- Percentage of Participants With Deterioration in Trial Outcome Index (TOI) Using FACT-L Version 4.0(Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years))
- Time to Deterioration in TOI Using FACT-L Version 4.0(Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years))
- Percentage of Participants With Deterioration in Quality of Life (QOL) Using FACT-L Version 4.0(Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years))
- Time to Deterioration in QOL Using FACT-L Version 4.0(Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years))
- Median Follow-up Time During the Study(Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 5.5 years]))