A Multicenter, Randomized, Open-Label, Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HS-20093 Injection Combined With Adebrelimab Versus HS-20093 Injection in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a multicenter, randomized, open-label, controlled phase II clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus HS-20093 injection in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.
详细描述
This is a multicenter, randomized, open-label, controlled phase II clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus HS-20093 injection in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.
Eligible participants will be randomly assigned in a 1:1 ratio to the experimental arm (HS-20093 and adebrelimab) or the control arm (HS-20093 injection). Participants in the experimental arm will receive intravenous infusions of HS-20093 and adebrelimab until disease progression or other treatment discontinuation criteria are met. Participants in the control arm will receive HS-20093 injection until disease progression or other treatment discontinuation criteria are met. Efficacy and safety will be analyzed and evaluated in both arms following the protocol-specified follow-up procedures.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
- •Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
- •Previously treated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC).
- •Presence of at least one measurable target lesion.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to
- •Minimum life expectancy >12 weeks.
- •Adequate organ function.
- •Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
- •Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.
排除标准
- •Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer.
- •Prior or ongoing treatment with any of the following:
- •Prior or current treatment targeting B7-H3;
- •Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.;
- •Prior treatment with docetaxel monotherapy or in combination with other agents.
- •Persistent adverse reactions caused by prior treatment.
- •Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression (identified by radiographic imaging, regardless of symptoms).
- •History of other primary malignancies.
- •Presence of any of the following abnormal cardiac findings:
- •Evidence of currently clinically significant important arrhythmia or ECG abnormality;
- •Presence of risk factors causing QT interval prolongation or arrhythmic events.
- •Severe, uncontrolled, or active cardiovascular or cerebrovascular disease.
- •Severe or poorly controlled hypertension.
- •Severe or poorly controlled diabetes mellitus.
- •Clinically significant bleeding symptoms or significant bleeding tendency.
- •Severe infection.
- •History of severe arterial or venous thromboembolic events.
- •Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
- •Participants with active or history of autoimmune disease with potential for recurrence.
- •Prior occurrence of severe or life-threatening immune-mediated adverse events.
研究组 & 干预措施
HS-20093 and adebrelimab
干预措施: Adebrelimab Injection (Drug)
HS-20093 and adebrelimab
干预措施: HS-20093 for Injection (Drug)
HS-20093
干预措施: HS-20093 for Injection (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 3 years
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
Progression-Free Survival (PFS)
时间窗: Approximately 3 years
2\. Progression-Free Survival (PFS) assessed by investigator per RECIST v1.1
次要结局
- duration of response (DoR)(Approximately 3 years)
- Overall survival (OS)(Approximately 5 years)
- Adverse event (AE) and serious adverse event (SAE)(3 years)
- Changes from baseline in cardiac function [electrocardiogram (ECG)](3 years)