A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 主要终点
- Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.
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;
- •histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
- •measurable disease;
- •no previous chemotherapy for non-small cell lung cancer.
排除标准
- •unstable systemic disease;
- •any other malignancies in the last 5 years.
研究组 & 干预措施
Tarceva + gemcitabine/platinum
干预措施: erlotinib [Tarceva] (Drug)
Tarceva + gemcitabine/platinum
干预措施: gemcitabine (Drug)
Tarceva + gemcitabine/platinum
干预措施: cisplatin (Drug)
Tarceva + gemcitabine/platinum
干预措施: carboplatin (Drug)
Placebo + gemcitabine/platinum
干预措施: placebo (Drug)
Placebo + gemcitabine/platinum
干预措施: gemcitabine (Drug)
Placebo + gemcitabine/platinum
干预措施: cisplatin (Drug)
Placebo + gemcitabine/platinum
干预措施: carboplatin (Drug)
结局指标
主要结局
Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Week 8
Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than \[\>\]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.
次要结局
- Percentage of Participants With Confirmed CR or PR as Assessed by RECIST(Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases)
- Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST(Week 16)
- Duration of Response(Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases)
- Time to Progression(Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases)
- Progression-Free Survival (PFS)(Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases)
- Overall Survival(Date of randomization until date of death or date of last follow-up assessment)