A case of a patient who developed interstitial lung disease (ILD) after application of almonertinib, was reported in this paper, aiming to improve the clinical understanding and prevention awareness of this adverse reaction. A 76-year-old male patient with lung adenocarcinoma had been taking gefitinib for more than 10 months before switching to almonertinib due to disease progression. The dosage and administration of almonertinib were 110  mg orally once daily. After 28 days of treatment, the patient developed some symptoms such as cough, sputum production, wheezing, accompanied by lower limb edema, poor appetite, and general fatigue. Chest CT showed that the patient's left lung had obvious interstitial pneumonia, which was considered to be drug-induced ILD caused by almonertinib based on the medication history. Almonertinib was discontinued on the second day of admission, and symptomatic treatments such as corticosteroids, anti-infection therapy, cough and wheezing relief, as well as supportive treatments such as oxygen therapy, were administered. After half a month of treatment, the patient's related symptoms had significantly improved. The causality between this adverse reaction and almonertinib was evaluated using the Naranjo's adverse drug reaction probability scale, with a score of 5, indicating a "probable" relationship. This case suggests the importance of vigilance for almonertinib use in clinical practice, and that when new respiratory symptoms occur, a timely diagnosis should be made. Once diagnosed with ILD, early treatment should be sought to improve prognosis.

1. Liu Y, Ge X, Pang J, et al. Restricting glutamine uptake enhances NSCLC sensitivity to third-generation EGFR-TKI almonertinib[J]. Front Pharmacol, 2021, 12: 671328. DOI: 10.3389/fphar.2021.671328.

2. Nagasaka M, Zhu VW, Lim SM, et al. Beyond osimertinib: the development of third-generation EGFR tyrosine kinase inhibitors for advanced EGFR+ NSCLC[J]. J Thorac Oncol, 2021, 16(5): 740-763. DOI: 10.1016/j.jtho.2020.11.028.

3. 阿美乐第三项适应症获批上市, 用于Ⅲ期不可切NSCLC患者放化疗后的维持治疗[EB/OL]. (2025-03-10) [2026-02-28]. https://tc.hspharm.com/news/news-detail-513291.htm.

4. Lu S, Wang Q, Zhang G, et al. Efficacy of aumolertinib (HS-10296) in patients with advanced EGFR T790M+ NSCLC: updated post-national medical products administration approval results from the APOLLO registrational trial[J]. J Thorac Oncol, 2022, 17(3): 411-422. DOI: 10.1016/j.jtho.2021.10.024.

5. Wang L, Yang P, Luo H. Benefit of switching to firmonertinib following almonertinib-induced interstitial pneumonitis in a patient with advanced non-small-cell lung cancer: a case report[J]. Anticancer Drugs, 2025, 36(8): 682-685. DOI: 10.1097/CAD.0000000000001742.

6. 孙雪林, 杜娇, 谭琴, 等. 阿美替尼上市后不良反应分析[J]. 中国药物警戒, 2024, 21(6): 683-686. [Sun XL, Du J, Tan Q, et al. Analysis of post-marketing adverse reactions of ametinib[J]. Chinese Journal of Pharmacovigilance, 2024, 21(6): 683-686.] DOI: 10.19803/j.1672-8629.20240089.

7. Rawat BPS, Jagannatha A, Liu F, et al. Inferring ADR causality by predicting the Naranjo Score from Clinical Notes[J]. AMIA Annu Symp Proc, 2021, 2020: 1041-1049. https://med.wanfangdata.com.cn/Paper/Detail?id=PeriodicalPaper_PM33936480&dbid=WF_NSTL.

8. Gawli CS, Patil CR, Patel HM. A clinical review on third and fourth generation EGFR tyrosine kinase inhibitors for the treatment of non-small cell lung cancer[J]. Bioorg Med Chem, 2025, 123: 118146. DOI: 10.1016/j.bmc.2025.118146.

9. Zhang Q, He C, He T, et al. 86P Aumolertinib as adjuvant therapy in postoperative EGFR-mutated non-small cell lung cancer[J]. Annals Oncol. 2022, 33(2): 73. DOI: 10.1016/j.annonc.2022.02.095.

10. Ohmori T, Yamaoka T, Ando K, et al. Molecular and clinical features of EGFR-TKI-associated lung injury[J]. Int J Mol Sci, 2021, 22(2): 792. DOI: 10.3390/ijms22020792.

11. 金辉, 王陈翔, 周子晔. 吉非替尼所致间质性肺病文献分析与对策探讨[J]. 药物流行病学杂志, 2020, 29(5): 359-363. [Jin H, Wang CX, Zhou ZY. Analysis and countermeasure of interstitial lung disease induced by gefitinib[J]. Chinese Journal of Pharmacoepidemiology, 2020, 29(5): 359-363.] DOI: 10.19960/j.cnki.issn1005-0698.2020.05.013.

12. Yang W, Shi L, Wang H, et al. Almonertinib-induced interstitial lung disease in an NSCLC patient co-harboring EGFR Ex19del mutation and MET de novo amplification: a case report and literature review[J]. Front Oncol, 2025, 15: 1481244. DOI: 10.3389/fonc.2025.1481244.

13. 中国抗癌协会肺癌专业委员会. EGFR-TKI不良反应管理专家共识[J]. 中国肺癌杂志, 2019, 22(2): 57-81. [Chinese Society of Lung Cancer, Chinese Anti-Cancer Association. EGFR-TKI ADR management Chinese expert consensus[J]. Chinese Journal of Lung Cancer, 2019, 22(2): 57-81.] DOI: 10.3779/j.issn.1009-3419.2019.02.01.

14. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [EB/OL]. (2017-11-27) [2025-10-14]. https://dctd.cancer.gov/research/ctep-trials/for-sites/adverse-events/ctcae-v5-5x7.pdf.

15. Conte P, Ascierto PA, Patelli G, et al. Drug-induced interstitial lung disease during cancer therapies: expert opinion on diagnosis and treatment[J]. ESMO Open, 2022, 7(2): 100404. DOI: 10.1016/j.esmoop.2022.100404.