NCT06465238尚未招募2 期
A Phase II Study of the Efficacy and Safety of SHR-A1921 or SHR-A2009 in Patients With Previously Treated Advanced NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This study is an open-label Phase II clinical trial to evaluate the safety and efficacy of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 participation and written informed consent;
- •Aged 18-75 years (inclusive), males and females;
- •Has a histologically or cytologically confirmed diagnosis of metastatic NSCLC (according to 8th AJCC/UICC Classification);
- •Has failed to standard therapy and disease progressed after antibody-conjugated drugs therapy;
- •Has at least 1 measurable lesion per RECIST 1.1;
- •Patients with ECOG score of 0-1;
- •Life expectancy ≥12 weeks;
- •Have adequate organ function;
- •Participants agrees to use contraception, and be abstinent from heterosexual intercourse during the treatment period and for ≥180 days after the last dose of study treatment.
排除标准
- •Histologically or cytologically confirmed presence of small-cell lung cancer or other benefit-limiting tumor components;
- •Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression;
- •Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
- •Subjects who have received systemic anti-tumor treatments prior to the initiation of the study treatment;
- •Has received major organ surgery or high-intensity thoracic radiotherapy within before first dose of study therapy；
- •Has a history of a second malignancy;
- •Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
- •Subjects with active pulmonary tuberculosis infection；
- •Serious infection before the first dose；
- •Uncontrolled cardiac diseases or symptoms;
- •Arterial/venous thrombosis events occurred before the first dose；
- •Hypertension that can not be well controlled through antihypertensive drugs，previous hypertensive crisis or hypertensive encephalopathy；
- •Has a history of active chronic enteritis;
- •Has a history of bleeding prior to the initiation of the study treatment;
- •History of immunodeficiency disease or organ transplant;
- •Subjects with active hepatitis B or active hepatitis C;
- •Has unresolved toxicities from previous anticancer therapy;
- •Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921or SHR-A2009;
- •Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.
研究组 & 干预措施
Treatment group 1
Experimental
SHR-A2009
干预措施: SHR-A2009 (Drug)
Treatment group 2
Experimental
SHR-A1921
干预措施: SHR-A1921 (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: up to 12 months
Assessed by Investigator According to RECIST v1.1
次要结局
- Progression-free survival (PFS)(up to 12 months)
- overall survival (OS)(up to 24 months)
- Duration of response(DoR )(up to 12 months)
- Disease control rate (DCR)(up to 12 months)
- Time to Response (TTR)(up to 12 months)
- The incidence and severity of adverse events (AEs)(from Day1 to 90 days after last dose)
研究者
Qiming Wang
Professor
Henan Cancer Hospital
研究点 (1)
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