The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- disease progression-free survival
研究概览
简要总结
To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC
详细描述
In preclinical data, it is identified that pemetrexed combined with erlotinib could achieve good response than pemetrexed because EGFR-TKI (erlotinib) could enhance the sensitivity of pemetrexed. So we design the trial to investigate curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Histological or cytological diagnosis of small-cll lung cancer histology
- •2.18 years or older
- •3.Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
- •4.Local stage SCLC without distant metastases
- •5.After 1st-line chemotherapy (EP or IP) at least 4 cycles
- •6.After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
- •7.CR or PR assessment by RECIST(1.0) before randomized
- •8.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
- •9.Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
- •10.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
排除标准
- •Mixed non-small cell lung cancer histology
- •Neck and supraclavicular lymph node metastasis
- •Be allergic to temozolomide or intolerable to radiotherapy
- •Any unstable systemic disease
- •Pregnant or lactating women
研究组 & 干预措施
pemetrexed/cisplatin intercalating gefitinib
pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 ;gefitinib 250mg d3-20d, to 4 cycles.
pemetrexed 500mg/m2 d1; gefitinib 250mg d2-20d to disease progression or untolerable
干预措施: pemetrexed/cisplatin intercalating gefitinib (Drug)
pemetrexed/cisplatin
pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable
干预措施: pemetrexed/cisplatin (Drug)
结局指标
主要结局
disease progression-free survival
时间窗: 3 years
the last patient into group for three years or dead
次要结局
- side-effects(3 years)
- overall survival(5 years)
- overall response rate(3 years)
研究者
Haihong Yang, MD, Pricipal investigator
Chief Physician
Guangzhou Medical University