A Phase 3, Randomised, Double-blind Study to Compare the Efficacy, Safety, PK and Immunogenicity Between SB8 (Proposed Bevacizumab Biosimilar) and Avastin® in Subjects With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 763
- 试验地点
- 104
- 主要终点
- Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks
研究概览
简要总结
This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
详细描述
Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between SB8 and bevacizumab.
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
- •Aged ≥ 18 years
- •ECOG performance status of 0-1
- •Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
- •At least one measurable lesion according to RECIST v1.
- •Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters
排除标准
- •Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
- •Sensitizing EGFR mutations or ALK rearrangements
- •Increased risk of bleeding determined by investigator based on radiographic / clinical findings
- •History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.
研究组 & 干预措施
Bevacizumab (Avastin)
Avastin® + Carboplatin/Paclitaxel
干预措施: Bevacizumab (Drug)
Bevacizumab (Avastin)
Avastin® + Carboplatin/Paclitaxel
干预措施: Carboplatin (Drug)
Bevacizumab (Avastin)
Avastin® + Carboplatin/Paclitaxel
干预措施: Paclitaxel (Drug)
SB8 (A proposed bevacizumab biosimilar)
SB8 + Carboplatin/Paclitaxel
干预措施: SB8 (Drug)
SB8 (A proposed bevacizumab biosimilar)
SB8 + Carboplatin/Paclitaxel
干预措施: Carboplatin (Drug)
SB8 (A proposed bevacizumab biosimilar)
SB8 + Carboplatin/Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks
时间窗: 24 weeks from randomisation
The best ORR was defined as the proportion of subjects whose best overall response was either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 during the induction treatment period by 24 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Progression Free Survival(from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject)
- Overall Survival(from the date of randomisation to the date of death up to 12 months from randomisation of the last subject)
- Duration of Response (DoR)(from documented tumour response until disease progression up to 12 months from randomisation of the last subject)
- Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03(AEs were reported from the time the informed consent form (ICF) was signed until the EOT visit, approximately 24 months from study initiation.)
- Pharmacokinetics: Trough Level [Ctrough](Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.))
- Pharmacokinetics: Maximum Plasma Concentration [Cmax](Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.))
- Immunogenicity Assessments (Anti-drug Antibodies)(Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation.)
- Immunogenicity Assessments (Neutralizing Antibodies)(Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation.)