A Randomized, Double-blind, Phase 3 Bridging Study Evaluating the Safety and Efficacy of ABP 215 Compared With Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Amgen
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of this research study is to assess the efficacy and safety of ABP 215 compared to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).
详细描述
Approximately 170 subjects will be randomized 1:1 in approximately 40 sites in China. This study consists of a screening period of up to 28 days, followed by a treatment period of 18 weeks, and an end of study visit 3 weeks after the last dose of investigational product or study-specified chemotherapy. After randomization, subjects will receive investigational product at a dose of 15 mg/kg administered every 3 weeks for 6 cycles followed by at least 4 and no more than 6 cycles of carboplatin and paclitaxel chemotherapy every 3 weeks.
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)
盲法说明
Subjects, Amgen, designated PAREXEL, and other clinical site staff will be blinded to the investigational product allocation for each subject.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed non-squamous NSCLC.
- •Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 and no more than 6 cycles of chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0 or
- •Other inclusion criteria may apply.
排除标准
- •Small cell lung cancer (SCLC) or mixed SCLC and NSCLC.
- •Central nervous system (CNS) metastases.
- •Malignancy other than NSCLC.
- •Palliative radiotherapy for bone lesions inside the thorax.
- •Prior radiotherapy of bone marrow.
- •Active hepatitis B.
- •Active hepatitis C.
- •Tested positive for human immunodeficiency virus (HIV).
- •Life expectancy < 6 months.
- •Woman of childbearing potential who is pregnant or is breast feeding.
- •Woman of childbearing potential who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment.
- •Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment.
- •Other exclusion criteria may apply.
研究组 & 干预措施
ABP 215
Subjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles.
All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles.
干预措施: ABP 215 (Drug)
ABP 215
Subjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles.
All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles.
干预措施: Paclitaxel (Drug)
ABP 215
Subjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles.
All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles.
干预措施: Carboplatin (Drug)
Bevacizumab
Subjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles.
All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles.
干预措施: Bevacizumab (Drug)
Bevacizumab
Subjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles.
All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles.
干预措施: Paclitaxel (Drug)
Bevacizumab
Subjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles.
All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: From Day 1 to Week 19 (EOS)
The percentage of subjects with a best overall tumor response of Complete Response (CR) or Partial Response (PR).
次要结局
- Number of participants with incidence of anti-drug antibodies (ADAs)(On Week 1, Week 7, Week 13 and Week 19 (EOS))
- Area Under the Curve (AUC)(Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS))
- Progression-free survival (PFS)(From Day 1 to Week 19 (EOS))
- Duration of response (DOR)(From Day 1 to Week 19 (EOS))
- Minimum observed concentration (Cmin)(Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS))
- Number of participants with treatment-emergent adverse events(From Screening to Week 19 (EOS))
- Maximum Plasma Concentration (Cmax)(Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS))
- Number of participants with treatment-emergent events of interest (EOIs)(From Screening to Week 19 (EOS))