A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.
详细描述
To evaluate the incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicity in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with AMG 386 in combination with pemetrexed and carboplatin
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC)
- •Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications
- •Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL ≥ 45 mL/min
- •Other criteria may apply
排除标准
- •Any prior chemotherapy or targeted therapy for non-squamous NSCLC
- •Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
- •Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
- •Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations
- •History or presence of central nervous system metastases
- •Central (chest) radiation therapy within 28 days prior to enrollment/randomization, radiation therapy to any other site(s) within 14 days prior to enrollment/randomization
- •History of pulmonary hemorrhage or gross hemoptysis within 6 months
- •History of arterial or venous thromboembolism within 12 months
- •History of clinically significant bleeding within 6 months
- •Clinically significant cardiovascular disease within 12 months
- •Other criteria may apply
研究组 & 干预措施
Arm A
Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
干预措施: AMG 386 Placebo (Drug)
Arm A
Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
干预措施: Pemetrexed (Drug)
Arm A
Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
干预措施: Carboplatin (Drug)
Arm B
Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
干预措施: AMG 386 (Drug)
Arm B
Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
干预措施: Pemetrexed (Drug)
Arm B
Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
干预措施: Carboplatin (Drug)
Arm C
Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
干预措施: AMG 386 (Drug)
Arm C
Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
干预措施: Pemetrexed (Drug)
Arm C
Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Incidence of adverse events and clinical laboratory abnormalities defined as a DLT
Subjects will be evaluated for progression free survival.
次要结局
未报告次要终点