NCT07778745尚未招募2 期
A Prospective Phase II Clinical Trial Evaluating the Efficacy and Safety of Adebrelimab in Combination With Trastuzumab Rezetecan for Patients With Stage III Unresectable HER2-Positive NSCLC
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
- 入组人数
- 37
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a single-arm, open-label, multicenter phase II investigator-initiated trial. The study aims to explore the efficacy and safety of Adebrelimab plus Trastuzumab rezetecan induction therapy in patients with stage III unresectable HER2-altered non-small cell lung cancer (NSCLC). Eligible patients receive 3-4 cycles Q3W induction combination therapy. After induction, patients will receive radical surgery or concurrent chemoradiotherapy via MDT evaluation, followed by consolidation therapy and long-term survival follow-up. The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include surgical conversion rate, major pathological response (MPR), event-free survival (EFS), overall survival (OS), and safety profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Aged 18-75 years, male or female.
- •Histologically or cytologically confirmed stage III unresectable NSCLC per AJCC 9th edition, judged unresectable by institutional MDT team.
- •Confirmed HER2 alteration: HER2 mutation/amplification detected by tissue NGS, or HER2 protein overexpression (IHC 2+ or 3+).
- •No prior systemic anti-tumor therapy for NSCLC; prior anti-tumor Chinese herbal medicine allowed if ≥2 weeks washout before first dose.
- •At least 1 measurable target lesion per RECIST v1.
- •ECOG performance status 0 or
- •Able to provide tumor tissue specimen (archival ≤6 months or newly biopsied non-irradiated lesion).
- •FEV1 >1.0 L and FEV1% predicted >40% within past 3 months.
- •Adequate organ function within 7 days before first dose (no blood product/G-CSF support within 14 days):
- •Hematology: WBC ≥3.0×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90g/L
- •Liver: AST/ALT ≤2.5×ULN (≤5×ULN for liver metastasis), TBIL ≤1.5×ULN
- •Renal: Serum Cr ≤1.5×ULN or CrCl ≥50 mL/min
- •Cardiac: LVEF ≥50% by echocardiogram
- •Fertile male/female participants must use effective contraception during treatment and 6 months after last dose; female participants non-lactating, negative serum HCG within 14 days pre-first dose.
- •Voluntarily sign written informed consent, good compliance for follow-up.
排除标准
- •Mixed small cell/large cell neuroendocrine/sarcomatoid NSCLC histology.
- •Concurrent other actionable driver gene alterations (EGFR, ALK, MET, BRAF, RET etc.) besides HER
- •Past or concurrent other malignant tumor (except fully resected cancer ≥5 years without active treatment).
- •Prior thoracic radiotherapy.
- •Major surgery within 28 days or minor invasive surgery within 7 days before first dose.
- •HIV infection, active hepatitis B/C, organ transplant history, congenital/acquired immunodeficiency.
- •Systemic immune modulators (thymosin, interferon, IL-2) within 4 weeks pre-enrollment.
- •Uncontrolled severe cardiovascular disease, unstable angina or intervention-required ventricular arrhythmia within 1 month.
- •Confirmed or suspected interstitial lung disease, severe baseline pulmonary dysfunction interfering with lung toxicity monitoring.
- •Active uncontrolled ≥2 grade infection within 2 weeks before enrollment.
- •Active tuberculosis under treatment.
- •Known hypersensitivity to any component of study drugs or other monoclonal antibodies/fusion proteins.
- •Any condition judged by investigator to compromise participant safety or trial compliance.
研究组 & 干预措施
Experimental: Adebrelimab + Trastuzumab rezetecan Induction Therapy
Experimental
干预措施: Adebrelimab (Drug)
Experimental: Adebrelimab + Trastuzumab rezetecan Induction Therapy
Experimental
干预措施: Trastuzumab rezetecan (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: End of Cycle 3/Cycle 4 induction (each cycle 21 days). Surgery-eligible patients assess tumor 6-8 weeks after Cycle3 last dose; others evaluate at Cycle4 end, ±7-day imaging window.
Proportion of participants achieving Complete Response (CR) or Partial Response (PR) after 3-4 cycles induction therapy, assessed per RECIST v1.1 by investigators
次要结局
- Surgical Conversion Rate(Within 6 to 8 weeks after the last induction study drug infusion (42-56 days post final induction dose))
- Major Pathological Response (MPR) Rate(Within 4 weeks after curative lung resection (pathology report completion window))
- Event-Free Survival (EFS)(Up to 36 months after the first dose of study treatment (3-year full survival follow-up))
- Overall Survival (OS)(12 months, 18 months, 24 months, and 36 months after the first dose of study treatment)
- Safety Profile (Treatment-Related Adverse Events)(From the date of signed informed consent through 30 days after the last study treatment infusion; long-term safety follow-up continues up to 36 months post first dose for delayed irAEs.)
研究者
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