An Open-label, Single-arm, Multi-center, Phase 2 Study to Evaluate SHR-1210 Combination With BP102 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Whose PD-L1 Positive and EGFR/ALK Wild Type.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a Phase II, multicenter, open-label study designed to evaluate the safety and efficacy of SHR-1210 with BP102 in subjects who are chemotherapy naive and have Stage IIIB~IV non-squamous NSCLC. The primary end points are ORR and PFS.
In this study, subjects will receive SHR-1210 combined with BP102 until progression or unacceptable toxicity (SHR-1210 or BP102 for a maximum of 2 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
- •Subjects who are chemotherapy naive and have Stage IIIB-IV non-squamous NSCLC;
- •Gene diagnostic tests must show that subjects are with wild type of EGFR, ALK and ROS1;
- •Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening;
- •No prior systemic treatment;
- •Adequate hematologic and end organ function;
- •Female participants of childbearing potential must have a negative serum pregnancy test within -7 days of randomization and must be willing to use very efficient barrier methods of contraception or a barrier method plus a hormonal method starting with the screening visit through 6 months after the last dose Male participants with a female partner(s) of child-bearing potential must be willing to use very efficient barrier methods of contraception from screening through 6 months after the last dose.
排除标准
- •Significant cardiovascular disease;
- •Prior treatment with immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies;
- •History of autoimmune disease;
- •Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome;
- •Severe infection within 4 weeks prior to randomization;
- •Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study;
- •Major surgical procedure within 4 weeks prior to randomization;
- •History of hemoptysis within 12 weeks prior to randomization;
- •Inadequately controlled hypertension;
- •Evidence of bleeding diathesis or coagulopathy;
- •Prior allogeneic bone marrow transplantation or solid organ transplant;
- •Positive test for HIV, and patients with active hepatitis B or hepatitis C.
研究组 & 干预措施
SHR-1210+BP102
Subjects receive SHR-1210 200 mg and BP102 15 mg/kg in day 1 intravenously every 3 weeks, until disease progression or unacceptable toxicity.
干预措施: SHR-1210 (Drug)
SHR-1210+BP102
Subjects receive SHR-1210 200 mg and BP102 15 mg/kg in day 1 intravenously every 3 weeks, until disease progression or unacceptable toxicity.
干预措施: BP102 (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: up to approximately 1 year
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
Objective response rate (ORR)
时间窗: up to approximately 1 year
ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
次要结局
- Overall Survival Rate at 12-month (OSR)(up to 1 year)
- Number of participants with treatment-related adverse events (AEs)(up to approximately 1 year)
- Time to Response (TTR)(up to approximately 1 year)
- Duration of Response Rate (DoR)(up to approximately 1 year)
- Disease Control Rate (DCR)(up to approximately 1 year)