Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in the Treatment of Advanced Lung Adenocarcinoma: a Single-arm, Phase Ⅱ Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 6m-PFS%
研究概览
简要总结
The single arm clinical study is to evaluate the efficacy and safety of Tislelizumab combined with Bevacizumab and albumin paclitaxel in the treatment of advanced lung adenocarcinoma. All of the patients were received EGFR-TKI therapy for 1 line and disease progression. The primary endpoint is six months PFS and safety, the seconday endpoint is ORR and one-year OS rate.
详细描述
Patients who meet the inclusion criteria will receive Tislelizumab combined with Bevacizumab and albumin paclitaxel for 4 cycles. If there is no disease progression, the patient will continue to receive Tislelizumab maintenance therapy, until the disease progresses or death.
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
- •lung adenocarcinoma stage Ⅳ(according AJCC 8)
- •received EGFR-TKI for 1 line and disease progression
- •EGFR T790M negative
- •ECOG PS 0-2
排除标准
- •histology of mixed NSCLC with squamous cell carcinoma, neuroendocrine carcinoma and small cell carcinoma.
- •have received checkpoint inhibitor.
- •uncontrolled pleural effusion, pericardial effusion, or ascites after appropriate intervention
- •any unstable systemic disease
- •patients who were treated with systemic glucocorticoids (>10mg/ day prednisone therapeutic dose) or other immunosuppressive drugs within 14 days prior to the initial administration or during the study period
研究组 & 干预措施
Arm 1
Tislelizumab (200mg,Q3W )+Bevacizumab(15 mg/kg,Q3W)+Albumin paclitaxel(100mg/m2,d1,8,15) for 4 cycles, and if there is no disease progression, patients will receive Tislelizumab(200mg,Q3W) until progression or death.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
6m-PFS%
时间窗: through study completion, an average of 1 year
The proportion of 6 months progression free survival
Safety of Tislelizumab
时间窗: 30 days after the trial finished
TEAE are adverse events that occur during or after the first administration of the study drug until 30 days after the study drug is discontinued or the new anticancer treatment is initiated or worse than at baseline (before treatment)
次要结局
- OS rate(one year)
- ORR(one year)
研究者
Zhou Chengzhi
Chief Physician
Guangzhou Institute of Respiratory Disease