Chemotherapy in Combination With Erlotinib, or Sequential Chemotherapy for Erlotinib for Treatment, EGFR - TKI Resistance of EGFR Mutations in Patients With NSCLC Randomized Controlled Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 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 evaluate and compare safety and effectiveness of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR - TKI Resistance of EGFR Mutations
详细描述
from the first cycle of treatment (day one) to two month after the last cycle
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
- •Sign the informed consent
- •According to RECIST 1.1 standard, at least one measurable lesions
- •Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation
- •Palliative treatment has received two medicine first-line platinum-based chemotherapy and EGFR - TKI second-line treatment and objective clinical benefit (CR, PR or SD is more than 6 months), RESIST standard curative effect evaluation for progress
- •No serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency
- •Hb≥9g/dL；WBC≥3*109/L，ANC≥1.5*109/L，PLT≥75*109/L
- •Men or women of childbearing age in the experiment are willing to take contraceptive measures
- •Estimated survival period for 3 months or more
排除标准
- •The palliative chemotherapy ever use docetaxel and pemetrexed
- •small cell lung cancer non small cell hybrid
- •Women during pregnancy or lactation
- •In the past the anti-tumor treatment of any outstanding ease of > CTCAE 2 levels of toxicity
- •Ccr<30 ml/min (calculated by Cockcroft-Gault formula)
- •hepatic insufficiency： Tbil> 1.5×ULN ALT and AST > 2.5×ULN (Patients with liver metastasis>5×ULN) Alkaline phosphatase>2.5 ×ULN(Patients with liver metastasis>5×ULN)
- •Severe symptomatic heart disease
- •Symptomatic brain metastases
- •In the last 5 years have been or are suffering from other histological types of malignant tumor
- •There are serious or uncontrolled systemic diseases
- •During the study period planned radiotherapy on target lesion
- •During the study period, plans to use other antineoplastic therapy
- •Clinical study on treatment of 30 days beginning period prior to participate in any study drug
研究组 & 干预措施
combination with Erlotinib
Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
干预措施: docetaxel (Drug)
combination with Erlotinib
Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
干预措施: pemetrexed (Drug)
combination with Erlotinib
Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
干预措施: Erlotinib (Drug)
sequential chemotherapy for Erlotinib
docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd
干预措施: docetaxel (Drug)
sequential chemotherapy for Erlotinib
docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd
干预措施: pemetrexed (Drug)
sequential chemotherapy for Erlotinib
docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: from the first cycle of treatment (day one) to two month after the last cycle
次要结局
未报告次要终点