A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Patients With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 650
- 试验地点
- 18
- 主要终点
- Overall Response Rate (ORR) at Week 18
研究概览
简要总结
In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenicity.
详细描述
This is a randomised, double-blind, parallel group, equivalence, multicentre Phase III study in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between HD204 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
HD204 (Bevacizumab biosimilar)
HD204 + Carboplatin/Paclitaxel
干预措施: HD204 (Drug)
HD204 (Bevacizumab biosimilar)
HD204 + Carboplatin/Paclitaxel
干预措施: Carboplatin (Drug)
HD204 (Bevacizumab biosimilar)
HD204 + Carboplatin/Paclitaxel
干预措施: Paclitaxel (Drug)
Avastin (Bevacizumab)
Avastin® + Carboplatin/Paclitaxel
干预措施: Bevacizumab (Drug)
Avastin (Bevacizumab)
Avastin® + Carboplatin/Paclitaxel
干预措施: Carboplatin (Drug)
Avastin (Bevacizumab)
Avastin® + Carboplatin/Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall Response Rate (ORR) at Week 18
时间窗: 18 weeks from randomization
Percent patients within each treatment group who achieved complete response (CR) or partial response (PR) by the time of the Week 18 efficacy analysis in accordance with the RECIST 1.1. as assessed by CIR.
次要结局
- ORR at Week 6(6 weeks from randomization)
- Incidence of Treatment-related Adverse Events using CTCAE v5.0(From signing the ICF until 1 month after the last administration of treatment, i.e., up to 52 weeks)
- Change in tumour burden from baseline(Up to 52 weeks from baseline)
- ORR at Week 12(12 weeks from randomization)
- ORR at Week 18 adjusted on dose intensity(18 weeks from randomization)
- Duration of Response(from documented tumour response until disease progression up to 12 months from randomisation)
- Anti-Drug Antibodies (Immunogenicity)(Up to 52 weeks (at Baseline; end of Cycle 4 [pre-dose in cycle 5]; end of Cycle 7 [pre-dose in cycle 8]; and at EOT))
- Neutralizing Antibodies (Immunogenicity)(Up to 52 weeks (at Baseline; end of Cycle 4 [predose in cycle 5]; end of Cycle 7 [predose in cycle 8]; and at EOT))
- 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 (OS)(From the date of randomisation to the date of death up to 12 months from randomisation)
- Trough Level [Ctrough] (Pharmacokinetics)(Up to 52 weeks (end of Cycle 1 [predose of Cycle 2], end of Cycle 3 [predose of Cycle 4], end of Cycle 5 [predose of Cycle 6] and EOT))
- Maximum Plasma Concentration [Cmax] (Pharmacokinetics)(Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.))
- Area under the concentration-time curve from 0 hr to time t [AUC0-t] (Pharmacokinetics)(Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.))