NCT07836543尚未招募2 期
A Randomized, Open-label, Multicenter, Phase II Study of Trastuzumab Rezetecan With Adebrelimab, Trastuzumab Rezetecan Alone and Adebrelimab Alone as Consolidation Therapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Harboring HER2 Alterations Without Progression After Definitive Chemoradiotherapy
Ming Chen0 个研究点目标入组 105 人开始时间: 2026年9月1日最近更新:
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
- 发起方
- 入组人数
- 105
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
A randomized phase II study to assess the efficacy and safety of Trastuzumab Rezetecan and/or Adebrelimab as consolidation therapy following chemoradiotherapy in patients with unresectable stage III HER2-altered NSCLC.
详细描述
This is a randomized, open-label, multi-center phase II study evaluating the efficacy and safety of consolidation therapy with Trastuzumab Rezetecan combined with Adebrelimab versus Trastuzumab Rezetecan monotherapy versus Adebrelimab monotherapy in patients with unresectable stage III NSCLC harboring HER2 alterations (mutation or overexpression) who have not progressed after definitive concurrent or sequential chemoradiotherapy. Eligible patients will be randomized in a 1:1:1 ratio to receive either combination therapy, SHR-A1811 alone, or Adebrelimab alone for up to 12 months. The primary endpoint is progression-free survival (PFS) per RECIST v1.1.
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.
- •ECOG performance status 0-
- •Histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC).
- •Radiologically confirmed unresectable Stage III NSCLC per AJCC 9th edition.
- •Pathologically confirmed HER2 mutation or HER2 overexpression (IHC 2+ or 3+).
- •Life expectancy ≥3 months.
- •Completed at least two cycles of platinum-based chemotherapy (concurrent or sequential) with definitive radiotherapy. Consolidation chemotherapy after radiotherapy is not permitted; chemotherapy with or without immunotherapy before concurrent chemoradiotherapy is permitted.
- •Total radiotherapy dose 60 Gy ± 10% (54-66 Gy) using IMRT (preferred) or 3D-CRT, with acceptable dosimetric constraints.
- •Adequate organ and bone marrow function.
- •Negative pregnancy test for women of childbearing potential within 7 days prior to first dose. Willing to use effective contraception during the study and for 180 days after the last dose.
- •Signed informed consent form (ICF).
排除标准
- •Known EGFR-activating mutations or ALK fusions.
- •Presence of other driver gene mutations with approved targeted therapies available.
- •Mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.
- •Prior treatment with HER2-targeted ADCs or HER2 TKIs.
- •Malignant pleural effusion, pericardial effusion, or ascites.
- •Participation in another clinical trial within 4 weeks or 5 half-lives prior to first dose.
- •Systemic immunosuppressive therapy within 2 weeks prior to first dose.
- •Known HIV infection.
- •Active hepatitis B (HBsAg positive with detectable HBV-DNA and ALT > ULN) or active hepatitis C.
- •Active autoimmune disease requiring systemic treatment.
- •Other malignancies within 5 years, except adequately treated cervical carcinoma in situ, basal/squamous cell skin carcinoma, localized prostate cancer, or ductal carcinoma in situ.
- •Active or history of Grade ≥2 radiation pneumonitis per RTOG/EORTC, or symptomatic interstitial lung disease. Participants with grade 2 radiation pneumonitis that resolves to grade 1 or lower within 14 days without systemic glucocorticoid treatment may undergo screening if the investigator considers there to be no risk of recurrence.
- •Significant cardiovascular disease.
- •Severe infection within 4 weeks prior to first dose.
- •Prior or planned allogeneic bone marrow or solid organ transplantation.
- •Live attenuated vaccine within 28 days prior to first dose or planned during study. Pregnancy or breastfeeding.
- •Known hypersensitivity to Adebrelimab, Trastuzumab Rezetecan, or any excipients.
- •Known history of psychotropic substance abuse, alcohol abuse, or illicit drug use.
- •Any condition that might impair the subject's ability to comply with study requirements.
研究组 & 干预措施
Arm A (Combination Therapy)
Experimental
Drug: Trastuzumab Rezetecan + Adebrelimab
干预措施: Trastuzumab Rezetecan (SHR-A1811) + Adebrelimab (Drug)
Arm B (Targeted Monotherapy)
Experimental
Drug: Trastuzumab Rezetecan
干预措施: Trastuzumab Rezetecan (SHR-A1811) (Drug)
Arm C (Immunotherapy Monotherapy)
Experimental
Drug: Adebrelimab
干预措施: Adebrelimab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Assessed up to approximately 36 months.
Defined as the time from randomization to disease progression or death from any cause, whichever occurs first.
次要结局
- Incidence of Adverse Events (AEs)(Assessed up to approximately 36 months.)
- Overall Survival (OS)(Assessed up to approximately 60 months.)
- Objective Response Rate (ORR)(Assessed up to approximately 36 months.)
- Duration of Response (DoR)(Assessed up to approximately 36 months.)
- Disease Control Rate (DCR)(Assessed up to approximately 36 months.)
- Time to Death or Distant Metastasis (TTDM)(Assessed up to approximately 36 months.)
- Progression-Free Survival Rate at 6 Months(6 months after randomization.)
- Progression-Free Survival Rate at 12 Months(12 months after randomization.)
- Overall Survival Rate at 12 Months(12 months after randomization.)
- Overall Survival Rate at 24 Months(24 months after randomization.)
研究者
Ming Chen
Professor and Chief Physician
Sun Yat-sen University
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