EGFR 20外显子插入突变非小细胞肺癌规范化诊疗中国专家共识（2024版）

结语与展望

进行中

表 3 EGFR ex20ins NSCLC二/后线治疗的临床研究

INV评估的ORR

主要终点

治疗方案

埃万妥单抗

I期

后线

（n=114）

伏美替尼240 mg

后线

Ib期

IRC评估的ORR

分期

后线

（n=28）

伏美替尼160 mg

（n=28）

Tab 3 Clinical studies in second-line and later-line treatment of patients with EGFR ex20ins mutated NSCLC

安全性和初步疗效

I/IIa

Zipalertinib

（CLN-081）

（n=73）

期

BIRC评估的ORR

线数

BEBT-109

（目标n=100）

安全性和耐受性

PLB1004

II期

I期

后线

IRC评估的ORR

（n=65）

JMT101联合奥希

后线

II期

后线

替尼（n=112）

后线

安全性和耐受性；

II期：ORR

I期：MTD、RP2D、

BLU-451

I/II期

（n=19）

FWD1509 MsOH

I期

（目标n=30）

后线

[38,39]

CONCERTO

（NCT02609776）队列4

研究

[55]

安全性和耐受性

CTR20201697）

（NCT04858958/

[44]

CTR20213409

[52]

[49]

NCT04036682

[50,51]

随着EGFR ex20ins NSCLC的精准治疗受到临床上越来越多的关注以及更多新型化合物的深入探索及新型靶向药物的获批，针对EGFR ex20ins NSCLC患者的治疗选择也在更新迭代。因此，本共识专家组参考了2023版共识、最新国内外文献及临床数据，结合专家自身临床经验，形成2024版EGFR ex20ins NSCLC临床规范化诊疗专家共识。新版共识指出：首先，应当进一步重视并提高对EGFR ex20ins靶点及其疾病临床特征的认知；其次，在检测方面，推荐基于组织样本的NGS检测作为优选，组织样本不可及时可选择液体样本，对于PCR检测驱动基因全阴性的患者，建议在条件允许的情况下使用NGS进行复测；在治疗方面，当前国内尚无一线治疗EGFR ex20ins NSCLC的靶向药物获批，可参考局部晚期或转移性无驱动基因的NSCLC的一线治疗，而对于无法耐受或拒绝化疗或PS评分较差的患者，可选择舒沃替尼；EGFR ex20ins NSCLC二/后线治疗中，舒沃替尼作为国内唯一获批的口服靶向药物，填补了临床治疗上的空白，为经治的EGFR ex20ins NSCLC患者带来显著生存获益，优先推荐舒沃替尼；此外，多种新型靶向药物的临床研究正在进行中，医疗卫生工作者可持续关注相关数据并根据临

NCT06015503

BECOME

[53]（NCT05132777）

FAVOUR

CHRYSALIS

（NCT05241873）

[56]

NCT05068024

床实际情况推荐患者参与临床研究。随着临床研究数据的生成及更新、新药的获批、检测技术的发展，本共识也将定期更新，以期推动EGFR ex20ins NSCLC规范化诊疗的发展，为更多中国肺癌患者带来获益。

Competing interests

■e authors declare that they have no competing interests.

参 考 文 献

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（收稿日期：2024-07-03）（本文编辑：丁燕）

|||共识编写专家组成员|| |---|---|---|---| |专家组组长||崔久鬼|吉林大学第一医院| |周彩存|上海市东方医院|董晓荣|华中科技大学同济医学院附属协和医院| |||郭人花|南京医科大学第一附属医院| |专家组副组长 (按姓氏汉语拼音字母排序)|专家组副组长 (按姓氏汉语拼音字母排序)|李林|北京医院| |程|吉林省肿瘤医院|李体|蚌埠医科大学| |楚云|浙江省肿瘤医院|梁莉|北京大学第三医院| |王|中国医学科学院肿瘤医院/|林根|福建省肿瘤医院| ||中国医学科学院肿瘤医院山西医院|刘晓睛|307医院全军肿瘤中心| |王哲海|山东第一医科大学附属肿瘤医院|马虎|遵义医科大学第二附属医院| |||任胜祥|同济大学附属上海市肺科医院| |执笔专家(按姓氏汉语拼音字母排序)|执笔专家(按姓氏汉语拼音字母排序)|沈波|江苏省肿瘤医院| |吴凤英|同济大学附属上海市肺科医院|王佳蕾|复旦大学附属肿瘤医院| |周斐|上海市东方医院|乌鹿粼|湖南省肿瘤医院| |||如兆煜|西安交通大学第一附属医院| |专家组成员 (按姓氏汉语拼音字母排序)|专家组成员 (按姓氏汉语拼音字母排序)|专家组成员 (按姓氏汉语拼音字母排序)|中国医科大学附属第一医院| ||华中科技大学同济医学院附属同济医院|周建娅|浙江大学医学院附属第一医院|

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