NCT05519865已完成2 期
A Randomized, Double-blind, Controlled, Multi-center Phase II Clinical Trial of Tucidinostat Combined With Tislelizumab as First-line Treatment for PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Chipscreen Biosciences, Ltd.1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2022年10月26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
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) per RECIST v1.1
研究概览
简要总结
A Randomized, Double-blind, Controlled, Multi-center Phase 2 Clinical study to Investigate the Efficacy and Safety of Tucidinostat (Chidamide) Combined with Tislelizumab as First-line Treatment for PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years, Male or female.
- •Histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic (stage IIIB-IV) NSCLC.
- •Must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
- •Must have positive PD-L1 expression in tumor tissue.
- •ECOG performance status of 0 or
- •Must Have ≥1 measurable target lesion as defined by RECIST v.1.
- •Must have adequate organ function.
- •Life expectancy ≥ 12 weeks.
- •Signed informed consent form (ICF).
排除标准
- •With EGFR or ALK gene mutation.
- •Received prior targeted therapy.
- •Prior use of HDAC inhibitor.
- •Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway.
- •Received any anti-tumor therapy or investigational agent and device within 28 days before the first dose of study treatment.
- •Received radiotherapy within 2 weeks or thoracic radiation >30Gy within 6 months before the first dose of study treatment.
- •Received systemic immunosuppressive drugs within 28 days before the first dose of study treatment. Inhaled or topical steroids and physiological dose of systemic glucocorticoid (≤10 mg daily prednisone equivalents) are permitted.
- •Received systemic immunostimulatory drugs within 28 days before the first dose of study treatment.
- •Received a live vaccine within 28 days before the first dose of study treatment or planned to receive during the study period. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; and COVID-19 vaccine also are allowed.
- •Received major surgery within 28 days before the first dose of study treatment.
- •Has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior anti-cancer therapy.
- •Has symptomatic and untreated central nervous system (CNS) metastases.
- •Has hydrothorax and ascites with obvious symptoms or requiring repeated drainage within 1 month before the first dose of study treatment.
- •Uncontrollable or major cardiovascular and cerebrovascular disease.
- •History of hemoptysis within 2 weeks or active bleeding within 2 months before the first dose of study treatment; or subject who is taking anticoagulants, or subject with clear high-risk bleeding tendency during the screening period.
- •History of serious thromboembolism within 6 months before the first dose of study treatment.
- •Suspected interstitial lung disease (ILD) or pulmonary fibrosis or pulmonary inflammation requiring treatment; or history of lung disease treated with oral or intravenous steroids within 6 months before the first dose of study treatment.
- •Obvious gastrointestinal abnormalities during the screening period, which may affect the intake, transport or absorption of drugs.
- •Urinary protein ≥ 2+ and quantitative urinary protein ≥ 1g/24 h during the screening period.
- •Active infection requiring intravenous therapy; or severe infection within 28 days before the first dose of study treatment.
- •Known active pulmonary tuberculosis, or subject who is receiving antituberculous treatment or having received antituberculous treatment within 1 year before the first dose of study treatment.
- •Active hepatitis B or hepatitis C.
- •HIV positive or history of AIDS or other serious infectious diseases.
- •History of malignant tumor.
- •Active autoimmune diseases during the screening period, and have received systemic treatment within 2 years before the first dose of study treatment.
- •History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Contraindications to any of the study drug ingredients.
- •History of hypersensitivity to monoclonal antibody, Chidamide, study drugs, or any of its excipients.
- •History of alcohol or drug abuse.
- •Unwilling or unable to comply with procedures required in this protocol.
- •Pregnant or breast-feeding women. Male/Female is unwilling or unable to use a highly effective method of birth control.
- •33. Any condition not suitable for participating in the trial in the opinion of the Investigator.
研究组 & 干预措施
Tucidinostat Combined with Tislelizumab
Experimental
Subjects receive Tucidinostat 30mg orally biw and Tislelizumab 200 mg intravenously (IV) Q3W.
干预措施: Tucidinostat (Drug)
Tucidinostat Combined with Tislelizumab
Experimental
Subjects receive Tucidinostat 30mg orally biw and Tislelizumab 200 mg intravenously (IV) Q3W.
干预措施: Tislelizumab (Drug)
Tislelizumab
Active Comparator
Subjects receive Tislelizumab 200 mg intravenously (IV) Q3W.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS) per RECIST v1.1
时间窗: Up to 2 years
PFS assessed by investigator per RECIST v1.1, measured from the date of randomization until progression or death, whichever is first met.
次要结局
- Progression Free Survival (PFS) per iRECIST(Up to 2 years)
- Duration of response (DOR)(Up to 2 years)
- time to progression (TTP)(Up to 2 years)
- Safety and Tolerability(Up to 2 years)
- Overall response rate (ORR)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- time to response (TTR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Progression-free survival of 6 months(6 months after randomization)
研究者
研究点 (1)
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