NCT04956146招募中2 期
A Single Arm,Open-label, Study of Fruquintinib Combined With Sintilimab and Chemotherapy in Patients With Unresectable or Metastatic Advanced Wild-type Genotype Non-squamous Non-small Cell Lung Cancer
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年2月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
A phase II study to assess the efficacy and safety of Fruquintinib Combined With Sintilimab and Chemotherapy as a first-line treatment in patients with unresectable or metastatic advanced Wild-type Genotype non-squamous 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
- •Voluntary provision of informed consent.
- •Males or females aged 18-
- •Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ).
- •Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, gene mutation)
- •At least one lesion can be measured by imaging.
- •Have not received systemic treatment in the past.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-
- •Life expectancy ≥ 12 weeks.
- •Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.
排除标准
- •Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
- •Diagnosed with other malignant diseases other than NSCLC within 5 years.
- •Have participated in other interventional clinical research treatments now or within 4 weeks.
- •Have previously received multi-targeted kinase inhibitors therapy.
- •Have active autoimmune diseases requiring systemic treatment within 2 years.
- •Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks.
- •Clinically uncontrollable pleural effusion/abdominal effusion.
- •Vaccinated vaccines or attenuated vaccines within 4 weeks before the group;
- •Pregnant or breastfeeding females.
- •Other serious hazards to the safety of patients.
研究组 & 干预措施
Fruquintinib Combined With Sintilimab and Chemotherapy
Experimental
干预措施: Fruquintinib，Sintilimab，Pemetrexed，Carboplatin (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: up to 24 months
To assess the efficacy of Fruquintinib Combined With Chemotherapy as second-
次要结局
- Overall Survival（OS）(up to 24 months)
- Objective response rate (ORR)(up to 24 months)
- Disease control rate (DCR)(up to 24 months)
研究者
研究点 (1)
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