A Phase Ⅰb/Ⅱ Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Phase Ⅱ: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1.
研究概览
简要总结
This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small cell lung cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subjects who have recurrent small cell lung cancer confirmed by histology or cytology.
- •Failed one prior line of platinum-based chemotherapy.
- •Subjects must have measurable disease, at least one lesion, by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria (within 28 days prior to administration of study treatment) ;
- •Freshly acquired samples or archived specimens within 12 months before randomization must be provided.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Participant must have a life expectancy ≥ 12 weeks.
排除标准
- •Active or untreated central nervous system (CNS) metastases.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •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.
- •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.
研究组 & 干预措施
Experimental A (part 1) : Fluzoparib + temozolomide
干预措施: Fluzoparib (Drug)
Experimental A (part 1) : Fluzoparib + temozolomide
干预措施: temozolomide (Drug)
Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316
干预措施: Fluzoparib (Drug)
Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316
干预措施: temozolomide (Drug)
Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316
干预措施: SHR-1316 (Biological)
结局指标
主要结局
Phase Ⅱ: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1.
时间窗: Up to approximately 2 Years
Progression Free Survival, defined as the time from randomization to first assessment of disease progression or death, whichever is earlier.
Phase Ⅰb: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.
时间窗: At the end of Cycle1 (each cycle is 21 days )
Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib and temozolomide with or without SHR-1316.
时间窗: Up to approximately 2 Years
Phase Ⅱ: Progression Free Survival (PFS) at four months.
时间窗: Up to approximately 2 Years
次要结局
- Disease Control Rate(Up to approximately 2 Years)
- Time to Response(Up to approximately 2 Years)
- Duration of Response(Up to approximately 2 Years)
- Objective Response Rate(up to approximately 2 Years)
- Overall survival and overall survival at 6 months, 9months and 12 months(Up to approximately 1 Year)