Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC Patients Intolerant to First-line Standard Chemotherapy: A Singlearm Phase Il Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy.
详细描述
This study is a clinical intervention study. The patients who comfirm the criteria will be treated with tislelizumab plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated. Drug administration regimen: tislelizumab 200mg intravenous drip once every 3 week3; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b-American Joint Committee on Cancer [AJCC] 8th edition) squamous NSCLC or non-squamous NSCLC without sensitising EGFR or ALK alterations.
- •Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
- •Has not received prior systemic treatment for metastatic NSCLC.
- •Has a life expectancy of at least 3 months.
- •Has fully understood this study and voluntarily signed a written informed consent form.
- •Deemed unsuitable by the investigator for any platinum-doublet chemotherapy due to poor performance status (ECOG performance status of 2-3)；>= 75 years of age；substantial comorbidities; contraindication(s) for any platinum-doublet chemotherapy.
排除标准
- •Histological or cytological confirmation of small cell lung cancer.
- •Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has disorders of oral medication.
研究组 & 干预措施
tislelizumab plus metronomic oral vinorelbine
干预措施: tislelizumab and metronomic oral vinorelbine (Drug)
结局指标
主要结局
PFS
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
progression-free survival
次要结局
- ORR(up to 12 months)
- DCR(up to 12 months)
- AE(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)