NCT04284202Unknown2 期
PD-1 Combined With Dasatinib for as Third-line Treatment for ARID1A Mutation Advanced NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to evalute the efficacy and safety of PD-1 antibody combined with Dasatinib as third-line therapy for NSCLC patients with ARID1A mutation until disease progression or intolerable toxicity or patients withdrawal of consent. The target sample size is 30+individuals. The primary endpoint of this study is PFS、ORR、OS and the secondary endpoint is toxicity.
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
- •Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures
- •over 18 years old
- •Metastatic (stage IV) NSCLCwith ARID1A mutation underwent 2 lines of prior treatment.
- •World Health Organization (WHO) performance status 0-2
- •Adequate bone marrow reserve and organ function as demonstrated by complete blood count, biochemistry in blood and urine at baseline
- •ECG recording at baseline showing absence of any cardiac abnormality as per exclusion criterion #5
- •Female patients of childbearing potential must be using adequate contraceptive measures must not be breast feeding, and must have a negative pregnancy test prior to start of dosing.
排除标准
- •Subjects with known EGFR and ALK mutations are excluded.
- •Subjects with untreated CNS metastases are excluded
- •Subjects with an active, known or suspected autoimmune disease.
- •Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody or any other antibody targeting T cell co-regulatory pathways.
- •Prior therapy with Dasatinib
- •Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
研究组 & 干预措施
PD-1 plus Dasatinib
Experimental
干预措施: PD-1 plus Dasatinib (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Event driven, an expected average of 6 months
次要结局
- Overall survival(OS)(An expected average of 24months)
研究者
zhangxiaochun
Director of Precision Medicine Center
The Affiliated Hospital of Qingdao University
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
PD-1 Antibody + Apatinib Mesylate in 2+ Line Serum AFP-elevated Gastric AdenocarcinomaAFPGastric CancerNCT04006821China Medical University, China30
Unknown
早期 1 期
A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal CancerEsophageal Squamous Cell CarcinomaNCT03940001Zhejiang Cancer Hospital20
Unknown
不适用
DEP Combine With PD-1 Antibody as an Treatment for EBV-HLHHemophagocytic LymphohistiocytosisNCT05164978Beijing Friendship Hospital20
Unknown
2 期
A Phase II Study of Anti-PD-1 Antibody, Sintilimab, as Second-line Therapy for Biomarker-selected Advanced or Metastatic NSCLCNon-small Cell Lung CancerNCT04612673China Medical University, China33
已完成
2 期
Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell TransplantationMultiple MyelomaNCT01067287Beth Israel Deaconess Medical Center35