2025年NCCN非小细胞肺癌临床实践（V1-V3）指南解读

doi:10.16150/j.1671-2870.2026.01.006

摘要/Abstract

摘要：

2022年，全球肺癌新发病例约250万，死亡病例180万，中国新发肺癌病例约106.06万，死亡病例73.33万，肺癌在中国及全球的发病率和死亡率均居恶性肿瘤首位。非小细胞肺癌（non-small cell lung cancer，NSCLC）占肺癌约85%，生物标志物检测对其治疗选择至关重要。2024年12月至2025年1月，美国国立综合癌症网络（National Comprehensive Cancer Network，NCCN）连续发布了NSCLC临床实践指南的2025年第一版（V1）、第二版（V2）和第三版（V3），部分内容更新在肺癌诊疗领域具有重要意义。V1指南主要更新内容包括初始治疗评估、生物标志物检测、优化特定基因突变治疗路径及新增新兴靶点治疗药物等，主要新增药物有厄达替尼针对成纤维细胞生长因子受体（fibroblast growth factor receptor， FGFR）基因、泽妥珠单抗针对神经调节蛋白1（neuroregulatory protein 1，NRG1）基因融合及德曲妥珠单抗针对人类表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）过表达等，为患者提供更多治疗选择。V2指南新增恩沙替尼作为间变性淋巴瘤激酶（anaplastic lymphoma kinase， ALK）重排的NSCLC一线优选方案。V3指南推荐纳武利尤单抗皮下注射替代静脉输注，用于新辅助系统治疗。尽管肺癌治疗的新靶点和新疗法不断涌现，但如何实现精准、可及且规范化的检测与治疗，仍是未来临床实践面临的核心挑战与优化方向。

关键词: 非小细胞肺癌, 指南解读, 生物标志物, 靶向治疗

Abstract:

In 2022, there were approximately 2.5 million newly-diagnosed cases of lung cancer and 1.8 million deaths worldwide. In China, there were about 1.060 6 million newly-diagnosed cases and 733 300 deaths from lung cancer. The incidence and mortality of lung cancer ranked first among malignant tumors in China and globally. Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer cases. Biomarker testing is crucial for its treatment selection. From December 2024 to January 2025, the National Comprehensive Cancer Network (NCCN) successively released the 2025 first (V1), second (V2) and third (V3) versions of clinical practice guidelines for NSCLC. Some of the updates are of great significance in the field of lung cancer diagnosis and treatment. The main updates in V1 include initial treatment evaluation, biomarker tes-ting, optimization of treatment pathways for specific gene mutations, and the addition of emerging targeted therapeutic drugs. Major newly added drugs include erdafitinib for the fibroblast growth factor receptor (FGFR) gene, zenocutuzumab for neuroregulatory protein 1 (NRG1) gene fusions, and trastuzumab deruxtecan for human epidermal growth factor receptor 2 (HER2) overexpression, providing patients with more treatment options. V2 adds ensartinib as the first-line preferred regimen for anaplastic lymphoma kinase (ALK) - rearranged NSCLC. V3 recommends nivolumab subcutaneous injection as an alternative to intravenous infusion for neoadjuvant system treatment. Despite the continuous emergence of new targets and therapies, how to achieve precise, accessible, and standardized testing and treatment remains the core challenge and optimization direction in future clinical practice.

Key words: Non-small cell lung cancer, Guideline interpretation, Biomarkers, Targeted therapy

中图分类号:

R734.2
R446

蔡姣迪, 陈国群, 张文琴. 2025年NCCN非小细胞肺癌临床实践（V1-V3）指南解读[J]. 诊断学理论与实践, 2026, 25(01): 37-43.

CAI Jiaodi, CHEN Guoqun, ZHANG Wenqin. Interpretation of the 2025 NCCN clinical practice guidelines for non-small cell lung cancer （V1-V3）[J]. Journal of Diagnostics Concepts & Practice, 2026, 25(01): 37-43.

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检测项目	内容	更新
基因检测	1类：EGFR、ALK、RET基因检测；2类：KRAS、ROS1、BRAF、NTRK1/2/3、 MET ex14、ERBB2（HER2）、NRG1基因检测	① RET是此次新增的1类推荐； ② NRG1为此次新增
IHC检测	1类：PD-L1；2类：HER2	HER2 IHC为此次新增

IHC表达结果	染色特征	评分
阴性	无染色或≤10%的癌细胞显示不完整和弱的细胞膜染色	0
阴性或低表达	>10%的癌细胞显示不完整和弱的细胞膜染色	1+
阳性	>10%的癌细胞显示弱至中等强度，完整的细胞膜染色，或≤10%的癌细胞显示强且完整的细胞膜染色	2+
阳性	>10%的癌细胞显示强、完整且均匀的细胞膜染色。	3+

参数	皮下注射纳武利尤单抗	静脉输注纳武利尤单抗
药代动力学非劣效性	是	无数据
客观缓解率	24.2%（95%CI为19.0%~30.0%）	18.2%（95%CI为13.6%~23.6%）
给药时间	3~5 min	30 min