A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced 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
- 172
- 主要终点
- Progression free survival
研究概览
简要总结
Part 1 is complete. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, phase 2 segment that will commence upon identification of the maximum tolerated dose in part 1. The Primary objective of Part 2 of the study is to estimate efficacy in combination with carboplatin and paclitaxel. Subjects will be randomized at a 1:1:1 ratio to 1 of 3 treatment arms. Subjects in each of the 3 arms will receive up to 6 cycles of paclitaxel/carboplatin (at the same dose and schedule in part 1) in combination with either AMG 655 at the maximum tolerated dose (Arm 1), AMG 655 at a lower dose (Arm 2), or AMG 655 placebo (Arm 3) IV Q3W. Randomization will be stratified by ECOG (0 or 1) and disease stage (IIIb or IV/recurrent).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease Related
- •Histologically or cytologically confirmed non-small cell lung cancer.
- •Subjects must have advanced non-small cell lung cancer defined as stage IIIB with malignant pleural effusion or stage IV or recurrent disease.
- •Planning to receive up to 6 cycles of chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic
- •Men or women > 18 years of age Ethical
- •Adequate Hematological, renal, hepatic and coagulation function General
- •Plan to begin protocol specific therapy < 7 days after enrollment/randomization
排除标准
- •Disease Related
- •Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
- •Prior chemotherapy as follows:
- •Any prior chemotherapy for advanced non-small cell lung cancer
- •Any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
- •Any prior chemoradiation.
- •Central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
- •Other abnormal medical conditions
- •Documented myocardial infarction or unstable/uncontrolled cardiac condition
- •History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
- •Major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, Minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
研究组 & 干预措施
Arm 2
Low Dose AMG 655 with paclitaxel/carboplatin
干预措施: AMG 655 (Drug)
Arm 3
Placebo with paclitaxel/carboplatin
干预措施: AMG 655 placebo (Other)
Arm 1
AMG 655 High doseplus paclitaxel/carboplatin
干预措施: AMG 655 (Drug)
结局指标
主要结局
Progression free survival
时间窗: Until disease progression
次要结局
- Objective response rate, duration of response, time to response, overall survival and incidence of adverse events and clinical laboratory abnormalities(Until disease progression)