A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- predictive value of TS expression
研究概览
简要总结
This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).
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
- •Histologically confirmed nonsquamous NSCLC
- •Stage IIIb, IV or recurrent NSCLC
- •Age ≥ 18years
- •ECOG performance status of 0 to 1
- •Known TS immunohistochemical analysis data
- •At least one measurable lesion by RECIST 1.1
- •No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC
- •Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
- •At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
- •Adequate renal function: estimated creatinine clearance ≥ 50mL/min
排除标准
- •Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.
- •Patients with post-obstructive pneumonia or uncontrolled serious infection
研究组 & 干预措施
TS positive cohort & Gem/Cis Tx arm
Among TS expression positive patients, some will be randomized to Gem/cis therapy
干预措施: Gemcitabine plus cisplatin (Drug)
TS+ cohort & Pem/Cis arm
Among patients with TS+, randomised to Pem/cis chemotherapy
干预措施: pemetrexed plus cisplatin (Drug)
TS negative cohort & Pem/Cis Tx arm
Among patients with TS-, some will be randomised to Pem/cis Tx arm
干预措施: pemetrexed plus cisplatin (Drug)
TS negative cohort & Gem/Cis Tx arm
Among patients with TS-, some will be randomised to Gem/Cis Tx arm
干预措施: Gemcitabine plus cisplatin (Drug)
结局指标
主要结局
predictive value of TS expression
时间窗: 12 months
To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value
次要结局
- response rate(12 months)