A Phase 2, Multicenter, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination With Paclitaxel and Carboplatin for Advanced Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 186
- 主要终点
- Objective tumor response rate
研究概览
简要总结
The purpose of this study is to estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and paclitaxel/carboplatin plus bevacizumab arm (Arm C) in subjects with advanced non-squamous 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
- •Men or women 18 years or older with histologically or cytologically confirmed advanced non-squamous NSCLC (unresectable stage IIIB with pericardial or pleural effusion or stage IV/recurrent)
- •Measureable disease per RECIST criteria modified
- •ECOG performance status of 0 or 1
- •Ability to take oral medications
- •Competent to give written informed consent
排除标准
- •Current or prior history of CNS metastases
- •Any prior chemotherapy for advanced NSCLC
- •History of pulmonary hemorrhage or gross hemoptysis within 6 months prior to randomization
- •Prior targeted therapies
- •Known history of allergy or hypersensitivity to paclitaxel or carboplatin
- •History of arterial or venous thrombosis within 52 weeks prior to randomization
- •History of bleeding diathesis or non-pulmonary bleeding within 14 days prior to randomization
- •Peripheral neuropathy > grade 1 per CTCAE Version 3.0
- •Myocardial infarction, cerebrovascular accident, grade 2 or greater peripheral vascular disease, transient ischemic attack, congestive heart failure, percutaneous transluminal coronary angioplasty/stent, ongoing arrythmias requiring medication or unstable angina within 52 weeks prior to randomization
- •Any kind of disorder that compromises the ability of the subject to comply with the study procedures
- •Uncontrolled hypertension as defined by resting blood pressure > 150/90 mm Hg. Anti-hypertensive medications are allowed if hypertension is stably controlled at the time of randomization.
- •Participation in therapeutic clinical trials or currently receiving other investigational treatment(s) within 30 days prior to randomization
- •Pregnant or breast feeding women
- •Known to be HIV, hepatitis B surface antigen, or hepatitis C positive
研究组 & 干预措施
A
AMG 706 125 mg once daily (QD) and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
干预措施: AMG 706 (Drug)
A
AMG 706 125 mg once daily (QD) and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
干预措施: Paclitaxel (Drug)
A
AMG 706 125 mg once daily (QD) and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
干预措施: Carboplatin (Drug)
B
AMG 706 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
干预措施: AMG 706 (Drug)
B
AMG 706 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
干预措施: Paclitaxel (Drug)
B
AMG 706 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
干预措施: Carboplatin (Drug)
C
Bevacizumab 15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
干预措施: Bevacizumab (Biological)
C
Bevacizumab 15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
干预措施: Paclitaxel (Drug)
C
Bevacizumab 15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Objective tumor response rate
时间窗: Response assessments will be obtained every 6 +/- 1 week until subjects develop disease progression.
次要结局
- Duration of response(Time from first objective tumor response to disease progression or death, if the death was due to disease progression.)
- Pharmacokinetics of AMG 706 when administered with paclitaxel and carboplatin in Arms A and B(From randomization until disease progression or death.)
- Progression free survival(Number of days from randomization tot he date of radiological evidence of disease progression or death.)
- Overall survival(Time from randomization to death.)
- Safety and tolerability in the 3 arms(From randomization until disease progression or death.)