Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of Tislelizumab combined with platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous non-small cell lung cancer. This study aims to provide more treatment options for patients with locally advanced non-small cell lung cancer.
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
- •Age 18-75 years old, gender is not limited;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients with stage IIIB/C-IV non-squamous non-small cell lung cancer confirmed by cytology or histology;
- •Patients who have not received prior systemic therapy;
排除标准
- •Patients with uncontrolled autoimmune diseases;
- •Patients who have had autoimmune reactions in the past 6 months and have not improved or are unstable despite appropriate treatment, such as untreated or unstable pneumonia, thyroiditis, myocarditis, etc.;
- •Patients known to carry driver gene mutations such as EGFR mutation, ALK translocation, BRAF, ROS1, RET, MET, etc.;
- •Patients who have received prior systemic therapy, or those who have received adjuvant or neoadjuvant therapy with a recurrence time of less than 3 months from the last treatment;
- •Patients with known allergies or contraindications to the study drug or its excipients;
- •Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test;
- •Female patients of childbearing potential or male patients with reproductive plans who are unwilling to use effective contraception during the entire trial period and for 6 months after the end of the trial;
- •Patients whose comorbidities or other conditions may affect compliance with the protocol or are deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
treatment arm
For patients with driver gene-negative stage IIIB/C-IV non-squamous non-small cell lung cancer, after 4 cycles of Tislelizumab combined with platinum-based doublet chemotherapy, if the tumor efficacy evaluation reaches SD, PR, or CR, radiotherapy will be administered to the tumor lesions combined withTislelizumab. After that, Tislelizumab maintenance therapy will be continued.
干预措施: SBRT combined with Tislelizumab followed by Tislelizumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to approximately 30 months
PFS is defined as the time from the first dose until the first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
次要结局
- Objective Response Rate (ORR)(Up to approximately 30 months)
- Overall Survival (OS)(Up to ~60 months)
- Disease Control Rate (DCR)(Up to ~24 months)
- Adverse events(Through study completion, an average of 2 year)