NCT07183189招募中3 期
A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib as First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations
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
- 576
- 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 is a randomized, controlled, open-label, multicenter Phase III clinical trial designed to compare the efficacy and safety of SHR-A2009 combined with aumolertinib versus aumolertinib monotherapy in treatment-naïve subjects with EGFR-mutated, 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
- 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 (inclusive) at the time of signing informed consent, regardless of gender.
- •Subjects with histologically or cytologically confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer, with EGFR mutations confirmed by tissue or blood specimens.
- •No prior systemic therapy for locally advanced, metastatic, or recurrent non-small cell lung cancer.
- •At least one measurable tumor lesion according to RECIST v1.
- •ECOG performance status of 0 or
- •Expected survival time ≥12 weeks.
- •Adequate bone marrow and organ function.
- •Subjects must provide informed consent prior to the trial and voluntarily sign a written informed consent form.
排除标准
- •Histologically or cytologically confirmed combined small cell lung cancer (SCLC), neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma components.
- •Subjects with a history of leptomeningeal metastasis, brainstem metastasis, or spinal cord metastasis.
- •Subjects with uncontrolled tumor-related pain, as determined by the investigator.
- •Clinically uncontrolled third-space fluid accumulation, as determined by the investigator.
- •Insufficient time interval between prior antitumor therapy and the first dose administration.
- •Major organ surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
- •History of other malignancies within ≤5 years prior to the first dose.
- •Subjects with a history of interstitial lung disease, or imaging at screening suggestive of suspected interstitial lung disease; or other moderate to severe pulmonary diseases severely affecting lung function.
- •Severe cardiovascular or cerebrovascular diseases.
- •Any severe or uncontrolled ocular lesions that, in the physician's judgment, may increase the patient's safety risk.
- •Refractory nausea, vomiting, chronic gastrointestinal diseases, etc.
- •Severe infections within 4 weeks prior to the first dose.
- •Subjects with arterial/venous thromboembolic events within 6 months prior to the first dose of the study drug.
- •Active tuberculosis infection.
- •History of immunodeficiency, including positive HIV test.
- •Active hepatitis B or hepatitis C.
- •Prior allogeneic hematopoietic stem cell transplantation or organ transplantation.
- •History of severe allergic reactions to aumolertinib or other monoclonal antibodies, or hypersensitivity to any component of SHR-A
- •Known history of alcohol or drug dependence or drug abuse.
- •Psychiatric disorders or poor compliance.
研究组 & 干预措施
investigational treatment group：SHR-A2009 combined with Aumolertinib
Experimental
干预措施: SHR-A2009 ; Aumolertinib (Drug)
control group ：Aumolertinib
Active Comparator
干预措施: Aumolertinib (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 38 months
Progression-free survival (PFS) assessed by BICR according to RECIST v1.1
时间窗: Up to approximately 38 months
次要结局
- overall survival (OS)(Up to approximately 60 months)
- Progression Free Survival(PFS by investigator)(Up to approximately 38months)
- Duration of response(DoR，by BICR and investigator )(Up to approximately 38 months)
- Disease control rate（DCR，by BICR and investigator）(Up to approximately 38 months)
- Incidence of AEs(from Day1 to 40 days after last dose)
- overall survival (OS)(Up to approximately 60 months)
- Progression Free Survival(PFS by investigator)(Up to approximately 38months)
- Duration of response(DoR，by BICR and investigator )(Up to approximately 38 months)
- Disease control rate（DCR，by BICR and investigator）(Up to approximately 38 months)
- Incidence of AEs(from Day1 to 40 days after last dose)
研究者
研究点 (1)
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