A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SHR-A1811 Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With HER2 Abnormalities
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- PFS
研究概览
简要总结
This is a phase II, open-label, single-arm study evaluating the efficacy and safety of SHR-A1811 (a HER2-targeted ADC) combined with AK112 (a PD-1/VEGF bispecific antibody) in patients with HER2-amplified or overexpressed locally advanced or metastatic NSCLC.
详细描述
The study consists of two cohorts: Cohort 1 includes patients who failed standard first-line therapy; Cohort 2 includes treatment-naïve patients. Patients will receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Signed ICF.
- •Life expectancy ≥3 months.
- •Histologically/cytologically confirmed locally advanced or metastatic/recurrent NSCLC, not eligible for curative surgery or definitive chemoradiotherapy.
- •Cohort 1: Failed prior first-line systemic therapy, with HER2 amplification or overexpression . Cohort 2: No prior systemic therapy, with HER2 amplification/overexpression .
- •≥1 measurable lesion per RECIST 1.
- •Adequate organ and bone marrow function.
- •Use of effective contraception.
排除标准
- •History of ILD, pneumonitis requiring steroids, or active non-infectious pneumonitis.
- •Arterial/venous thrombotic event within 6 months.
- •Significant cardiovascular disease.
- •Active autoimmune disease requiring systemic treatment.
- •Use of systemic immunosuppressants within 2 weeks prior.
- •Symptomatic pleural/pericardial/ascitic effusion requiring drainage.
- •Symptomatic, progressive, or diffusely spread CNS metastases.
结局指标
主要结局
PFS
时间窗: From date of first study treatment to the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to approximately 36 months.
Progression-free survival (PFS), defined as the time from first study treatment to disease progression or death from any cause, whichever occurs first. Disease progression is assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
次要结局
- DOR(From the date of first documented objective response to the date of first documented disease progression or death from any cause prior to progression, whichever occurs first, assessed up to approximately 36 months.)
- ORR(From first study treatment to disease progression or initiation of new anti-tumor therapy, assessed up to approximately 36 months.)
- OS(From date of first study treatment to date of death from any cause, assessed up to approximately 36 months.)
- Adverse Events(From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.)
- Serious Adverse Events(From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.)
- Treatment-Related Adverse Events(From first dose of study treatment through 90 days after the last dose or initiation of new anti-tumor therapy, whichever occurs first.)
研究者
Li Zhang, MD
Chief Physician
Sun Yat-sen University