Preoperative Stereotactic Body Radiotherapy and Tislelizumab (Immunotherapy) Plus Anlotinib for Operable Stage IB to III EGFR Wild-type Non-small Cell Lung Cancer（STATION）
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 主要终点
- Pathologic Complete Response(pCR, rate)
研究概览
简要总结
The neoadjuvant strategy of immunotherapy combined with chemotherapy has been recommended for resectable or potentially resectable tumors without driver-gene alterations.However, the AE of chemotherapy is more than 40%，which bring fear to the patients，especially for those who cannot tolerate or refuse chemotherapy.Several studies indicated that the strategies of chemo-free ,such as the combination of immunotherapy with antiangiogenic therapy or with SBRT, were safe and well tolerated, without increasing adverse reactions. Both of them have a promising efficacy with a manageable toxicity profile in patients with resectable NSCLC. The investigators aim to assess the activity and safety of neoadjuvant SBRT and immunotherapy plus antiangiogenic therapy in patients with resectable NSCLC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18 years or older
- •Eastern Cooperative Oncology Group performance status: 0 or 1
- •Clinical stage IB to IIIB (T3-4N2) Resectable NSCLC
- •Adequate cardiopulmonary and haematological function.
排除标准
- •Known EGFR-sensitising mutations and EML4-ALK fusions
- •Concomitant malignancy, history of another cancer within the past 3 years.
- •Current or previous use of immunosuppressive medication,active autoimmune disease, and interstitial lung disease or idiopathic pulmonary fibrosis on a screening radiographic scan
研究组 & 干预措施
Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib
干预措施: SBRT (Radiation)
Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib
干预措施: Immunotherapy (Drug)
Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib
干预措施: antiangiogenesis therapy (Drug)
结局指标
主要结局
Pathologic Complete Response(pCR, rate)
时间窗: At the time of surgery
次要结局
- Major pathologic response rate(MPR rate)，Disease-free survival（DFS, month），Event-free survival（EFS,month）(Major Pathologic Response (MPR, rate ):At the time of surgery Disease-Free Survival（DFS, month):From enrollment to disease recurrence or death from any cause Event-Free Survival（EFS,month）：From enrollment to the first pre-specified event)
研究者
Jianhua Fu
Professor
Sun Yat-sen University