A Multicenter, Randomized, Open-label, Parallel-group Study of Paclitaxel Liposome and Cisplatin Compared With Gemcitabine and Cisplatin as First-line Therapy in Advanced Squamous Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 536
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to investigate the efficacy and the safety of paclitaxel liposome and cisplatin compared with gemcitabine and cisplatin as first-line therapy in advanced squamous non-small-cell lung cancer .
详细描述
The purpose of this study is to investigate the efficacy and safety of paclitaxel liposome and cisplatin compared with gemcitabine and cisplatin as first-line therapy in advanced squamous non-small-cell lung cancer .
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
- •Aged 18-75 years old, both gender;
- •Squamous non-small-cell lung cancer (stage IIIB or IV) confirmed by histologically or cytologically ;
- •No prior chemotherapy, biological therapy or immunotherapy; or subjects have recurrence and metastasis more than 6 months after the end of chemotherapy, but not gemcitabine or paclitaxel;
- •At least one radiographically measurable or assessable lesion on chest CG according to RECIST1.1 (response evaluation criteria of solid tumors); regional lymph node metastases may also be measured or assessed by imaging (mediastinal lymph nodes);
- •Life expectancy of at least 12 weeks;
- •Before treatment, blood tests or biochemical measurements must meet the following criteria:
- •White blood cell count (WBC)≥ 4.0*10^9/L;
- •Neutrophil count (ANC)≥ 2.0*10^9/L;
- •Platelet count (PLT)≥ 100*10^9/L;
- •Hemoglobin (Hb)≥ 100g/L;
- •Hepatic function: serum bilirubin ≤ 1.5 times the upper normal limit,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit;
- •Renal function: creatinine ≤ 1.5 times the upper normal limit;
- •Signed informed consent.
排除标准
- •Hypersensitivity reaction to the interventional drugs;
- •Pregnant or breastfeeding;
- •Women or men of childbearing age who disagree with the use of effective contraceptive measures during the study period;
- •Brain metastase ;
- •Uncontrolled pleural effusion in patients with squamous non-small-cell lung cancer
研究组 & 干预措施
LP group
Liposome paclitaxel(Lipusu®) plus cisplatin. Paclitaxel liposome Sterile injection powder 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles. Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
干预措施: Paclitaxel Liposome (Drug)
LP group
Liposome paclitaxel(Lipusu®) plus cisplatin. Paclitaxel liposome Sterile injection powder 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles. Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
干预措施: Cisplatin (Drug)
GP group
Gemcitabine (Gemzar®) plus cisplatin. Gemcitabine hydrochloride for injection 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles. Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
干预措施: Gemcitabine (Drug)
GP group
Gemcitabine (Gemzar®) plus cisplatin. Gemcitabine hydrochloride for injection 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles. Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: From study entry to measured progressive disease, up to 2 years
Progression free survival will be calculated from study entry to documented disease progression using RECISTv1.1 or death from any cause, whichever occurs first.
次要结局
- Objective Response Rate(From study entry to measured progressive disease, up to 2 years)
- Overall Survival(From study entry to death from any cause, up to 2 years)
- Adverse events(From baseline until 21 days after the last dose)
- Correlation between gene sequence or expression level and therapeutic effect(From study entry untill radiological disease progression, up to 2 years)
- Quality of Life questionnaire(From study entry to measured progressive disease, up to 2 years)