NCT04041011已完成1 期
A Phase Ib Study of SHR-1316 in Combination With Fluzoparib（SHR-3162） in Small Cell Lung Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Part 1: 2. RP2D: Recommended dose for phase II study
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of SHR-1316 in combination with Fluzoparib（SHR-3162） in Small Cell Lung Cancer Patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be at least 18 years of age.
- •Histologically or cytologically confirmed SCLC.
- •Failed at least one prior line of platinum-based chemotherapy.
- •Patients must have measurable disease as defined by RECIST v1.
- •Adequate hematologic and organ function
- •Signed inform consent form
排除标准
- •Active or untreated central nervous system (CNS) metastases
- •Spinal cord compression not definitively treated with surgery and/or radiation .
- •Leptomeningeal disease
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •Malignancies other than SCLC within 5 years prior to randomization
- •History of autoimmune disease
- •Positive test result for human immunodeficiency virus (HIV)
- •Active hepatitis B or hepatitis C
- •Severe infections
- •Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment.
- •Significant cardiovascular disease
- •Prior allogeneic bone marrow transplantation or solid organ transplant
- •Treatment with systemic immunosuppressive medications prior to randomization
- •Pregnant or lactating women
- •History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
结局指标
主要结局
Part 1: 2. RP2D: Recommended dose for phase II study
时间窗: Up to approximately 24 months.
Part 1: 1.Number of Participants with AEs and SAEs
时间窗: Up to approximately 24 months.
Part 2: 1. ORR: Percentage of Participants With a CR or PR
时间窗: Up to approximately 24 months.
次要结局
- Part 1: 1. ORR: Percentage of Participants With a CR or PR(Up to approximately 24 months.)
- Part 2: 3. DCR: Percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.(Up to approximately 24 months.)
- Part 2: 1.Number of Participants with AEs and SAEs(Up to approximately 24 months.)
- Part 2: 4. PFS: PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.(Up to approximately 24 months.)
- Part 2: 2.DoR: Percentage of Participants With a CR or PR(Up to approximately 24 months.)
- Part 2: 5. OS: Baseline until death from any cause(Up to approximately 24 months.)
研究者
研究点 (1)
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