NCT02256852已完成2 期
Open Label,Single Arm,Exploratory Study to Evaluate the Safety,Tolerability,Compliance and MOA,of QBKPN SSI in Subjects With 2 or More Second Primary Pre-invasive/Invasive Adenocarcinoma Following Surgical Resection of Stage I NSCLC
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety, tolerability and compliance variables
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, compliance and mechanism of action of study drug (QBKPN SSI) in subjects with two or more second primary pre-invasive or invasive adenocarcinoma following surgical section of Stage 1 NSCLC.
详细描述
Please refer to summary above.
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
- •Male or female who is at or above the age of consent
- •Histologically confirmed original diagnosis of lung cancer
- •Life expectancy greater than 12 months
- •ECOG performance status 0, 1, or 2 at screening
- •Female subjects who agree to practice two effective methods of contraception from the time of signing the informed consent form through one month after the last dose of study drug
- •Male subjects who agree to practice effective barrier contraception during the entire study drug period and through one month after the last dose of study drug
排除标准
- •Extra-thoracic lung cancer progression
- •Any active malignancies
- •Any uncontrolled or major organ dysfunction
- •Any past or current radiation or systemic therapies for the treatment of lung cancer
- •Known HIV infection or other immunosuppressive disorder
- •Concurrently participating in another study with an investigational immunotherapy or have received investigational immunotherapy within 3 months prior to screening
结局指标
主要结局
Safety, tolerability and compliance variables
时间窗: 16 weeks
Assess the number of adverse events and subject reported data
次要结局
- Exploratory variables(16 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
CONCERTA (OROS Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in AdultsAttention Deficit Disorder With HyperactivityNCT00246207Janssen-Ortho Inc., Canada32
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327Healthy ParticipantsIdiopathic Pulmonary Fibrosis (IPF)NCT04069143Bristol-Myers Squibb14
已完成
1 期
Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer SubjectsMetastatic Gastric CancerMetastatic Colorectal CancerMetastatic Lung CancerMetastatic Breast CancerNCT02310464OBI Pharma, Inc25
Unknown
1 期
UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid TumorsMesothelin-positive Advanced Malignant Solid TumorsNCT05848999Zhejiang University87
尚未招募
1 期
UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid TumorsSolid TumorNCT05775666Peking University87