A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" 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
- 70
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.
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
- •Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
- •Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at least 4 weeks prior to study enrolment.
- •Have 'never smoked' (defined as having smoked <100 cigarettes during his/her lifetime)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
排除标准
- •Concurrent administration of any other tumor therapy
- •Other co-existing malignancies
- •Pregnancy or breast feeding
- •Serious concomitant disorders
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation
研究组 & 干预措施
Pemetrexed/Cisplatin/Gefitinib
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
干预措施: Pemetrexed (Drug)
Pemetrexed/Cisplatin/Gefitinib
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
干预措施: Cisplatin (Drug)
Pemetrexed/Cisplatin/Gefitinib
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
干预措施: Gefitinib (Drug)
Pemetrexed/Cisplatin
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
干预措施: Pemetrexed (Drug)
Pemetrexed/Cisplatin
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Baseline to first observation of disease progression or death, 12 weeks up to 31 months
Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
次要结局
- Number of Participants With Tumor Response(Baseline to measured response or death, 12 weeks up to 31 months)
- Duration of Response for Responders(Time of response to progressive disease or death, 12 weeks up to 31 months)
- Overall Survival(Baseline to date of death from any cause, 12 weeks up to 31 months)