NCT06671379招募中3 期
A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) assessed by BICR according to RECIST v1.1
研究概览
简要总结
This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.
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
- 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
- •Age 18 to 75 years old (inclusive), Female or male
- •Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
- •Previously treated by EGFR-TKI；
- •At least one measurable tumor lesion according to RECIST v1.1
- •ECOG performance score of 0-1;
- •Expected survival time ≥ 12 weeks;
- •Adequate bone marrow and organ function
- •Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
排除标准
- •Subjects with active central nervous system (CNS) metastases.
- •Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
- •Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
- •Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
- •Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
- •Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
- •Serious cardiovascular disease
- •Presence of severe infection within 4 weeks prior to first dose of study drug
- •Arterial/venous thrombotic events within 3 months prior to the first study dose
- •History of immunodeficiency, including a positive HIV test
- •Presence of active hepatitis B or C;
- •History of allergic reactions to any component of study treatment or severe allergic reactions to other monoclonal antibodies.
研究组 & 干预措施
SHR-A2009 monotherapy
Experimental
干预措施: SHR-A2009 monotherapy (Drug)
platinum-based dual-agent chemotherapy
Active Comparator
干预措施: platinum-based dual-agent chemotherapy (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by BICR according to RECIST v1.1
时间窗: Up to approximately 32 months
次要结局
- overall survival (OS)(Up to approximately 32 months)
- Progression Free Survival(PFS by investigator)(Up to approximately 32 months)
- Duration of response(DoR，by BICR and investigator )(Up to approximately 32 months)
- Disease control rate（DCR，by BICR and investigator）(Up to approximately 32 months)
- Incidence of AEs(from Day1 to 40 days after last dose)
研究者
研究点 (1)
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