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中华胸部外科电子杂志 ›› 2026, Vol. 13 ›› Issue (03) : 218 -224. doi: 10.3877/cma.j.issn.2095-8773.2026.03.07

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围手术期派安普利单抗联合安罗替尼±化疗治疗可切除非小细胞肺癌的探索:解读ALTER-L043 Ⅱ期临床试验
武强1,2, 苏文泉1, 汪淑晶2,†(), 雷霆1,†()   
  1. 1116023 大连,大连医科大学第二附属医院胸外科
    2116044 大连,大连医科大学,基础医学院,生物化学与分子生物学教研室,辽宁省糖生物学与糖生物工程重点实验室
  • 收稿日期:2026-01-28 修回日期:2026-02-13 接受日期:2026-08-18 出版日期:2026-08-28
  • 通信作者: 汪淑晶, 雷霆
  • 基金资助:
    中国医药卫生事业发展基金会(HX20220039)

Perioperative penpulimab plus anlotinib with or without chemotherapy in resectable non-small cell lung cancer: an interpretation of the ALTER-L043 phase Ⅱ trial

Qiang Wu1,2, Wenquan Su1, Shujing Wang2,†(), Ting Lei1,†()   

  1. 1Department of Thoracic Surgery, The Second Hospital of Dalian Medical University, Dalian 116023, China
    2Department of Biochemistry and Molecular Biology, Liaoning Provincial Key Laboratory of Glycobiology and Glycoengineering, College of Basic Medical Sciences, Dalian Medical University, Dalian 116044, China
  • Received:2026-01-28 Revised:2026-02-13 Accepted:2026-08-18 Published:2026-08-28
  • Corresponding author: Shujing Wang, Ting Lei
引用本文:

武强, 苏文泉, 汪淑晶, 雷霆. 围手术期派安普利单抗联合安罗替尼±化疗治疗可切除非小细胞肺癌的探索:解读ALTER-L043 Ⅱ期临床试验[J/OL]. 中华胸部外科电子杂志, 2026, 13(03): 218-224.

Qiang Wu, Wenquan Su, Shujing Wang, Ting Lei. Perioperative penpulimab plus anlotinib with or without chemotherapy in resectable non-small cell lung cancer: an interpretation of the ALTER-L043 phase Ⅱ trial[J/OL]. Chinese Journal of Thoracic Surgery(Electronic Edition), 2026, 13(03): 218-224.

本研究围绕ALTER-L043 Ⅱ期随机临床试验展开,旨在探讨围手术期派安普利单抗(penpulimab)联合安罗替尼在联合或不联合化疗模式下治疗可切除非小细胞肺癌(NSCLC)的疗效与安全性。研究背景基于当前免疫检查点抑制剂联合化疗虽改善患者预后,但最佳联合策略及"去化疗"方案可行性仍有待探索。研究方法包括对ALTER-L043试验设计、人群特征、病理缓解率及安全性数据的全面分析,并与近年重要Ⅲ期试验对比。研究结果显示,派安普利单抗联合安罗替尼及化疗的三联方案主要病理缓解率高达76.0%(19/25),优于免疫化疗组[57.7%(15/26)]及去化疗双联组[52.4%(11/21)],且在鳞癌[79.0%(15/19)比55.0%(11/20)比50.0%(9/18)]和ⅢA/ⅢB期[82.4%(14/17)比55.6%(5/9)比50.0%(6/12)]患者中趋势更优;去化疗方案也展现潜力。安全性整体可控。因此,该联合策略为可切除NSCLC提供了新选择,三联方案或适用于高肿瘤负荷患者,去化疗方案为不耐受者提供替代,长期获益需Ⅲ期研究验证。

This study provides an in-depth interpretation of the ALTER-L043 phase II randomized trial, focusing on the efficacy and safety of perioperative penpulimab plus anlotinib with or without chemotherapy in resectable non-small cell lung cancer (NSCLC). The investigation was motivated by the need to optimize combination strategies beyond current immunotherapy-chemotherapy regimens, including the potential of "chemotherapy-free" approaches. The analysis encompassed the design, patient characteristics, pathological response rates, and safety profile of the trial, with comparisons to recent phase III studies. Results demonstrated that the triplet regimen achieved a major pathological response rate of 76.0% (19/25), surpassing the doublet regimens [57.7% (15/26) vs. 52.4% (11/21)], with notable benefits in squamous cell carcinoma [79.0% (15/19) vs. 55.0% (11/20) vs. 50.0% (9/18)] and stage ⅢA/ⅢB disease [82.4% (14/17) vs. 55.6% (5/9) vs. 50.0% (6/12)]. The chemotherapy-free doublet also showed promising efficacy. Safety profiles were manageable across groups. In conclusion, penpulimab plus anlotinib-based therapy offers a viable perioperative option, with the triplet regimen potentially suited for high-burden disease and the doublet providing an alternative for chemotherapy-ineligible patients, though phase Ⅲ confirmation is warranted.

图1 ALTER-L043研究设计。a化疗方案:非鳞状NSCLC,培美曲塞500 mg/m2 +卡铂(AUC=5)或顺铂75 mg/m2;鳞状NSCLC:紫杉醇175 mg/m2 +卡铂AUC=5或顺铂75 mg/m2。po:口服,iv:静脉注射,d1:每个周期的第1天,d1~14:每个周期的第1至14天,q3w:每3周一次[改编自Wang M, et al. Signal Transduct Target Ther, 2026, 11(1):21,本图片改编遵循知识共享署名4.0国际许可协议授权]。NSCLC:非小细胞肺癌;AUC:曲线下面积;ECOG:美国东部肿瘤协作组
表1 ALTER-L043研究与近期Ⅲ期围手术期免疫治疗研究病理缓解的对比
表2 ALTER-L043研究中新辅助治疗后手术取消原因汇总
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