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The DOI matches its Crossref record; 11 of the 11 references it cites were found in a registry or an index.

AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or MetastaticNon–Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations

Open access
Lu, Shun, Dong, Xiaorong, Jian, Hong, Chen, Jianhua, Chen, Gongyan, Sun, Yuping, Ji, Yinghua, Wang, Ziping, Shi, Jianhua, Lu, Junguo, Chen, Shaoshui, Lv, Dongqing, Zhang, Guojun, Liu, Chunling, Li, Juan, Yu, Xinmin, Lin, Zhong, Yu, Zhuang, Wang, Zhehai, Cui, Jiuwei, Xu, Xingxiang, Fang, Jian, Feng, Jifeng, Xu, Zhi, Ma, Rui, Hu, Jie, Yang, Nong, Zhou, Xiangdong, Wu, Xiaohong, Hu, Chengping, Zhang, Zhihong, Lu, You, Hu, Yanping, Jiang, Liyan, Wang, Qiming, Guo, Renhua, Zhou, Jianying, Li, Baolan, Hu, Chunhong, Tong, Wancheng, Zhang, Helong, Ma, Lin, Chen, Yuan, Jie, Zhijun, Yao, Yu, Zhang, Longzhen, Jie, Weng, Li, Weidong, Xiong, Jianping, Ye, Xianwei, Duan, Jianchun, Yang, Haihua, Sun, Meili, Sun, Changan, Wei, Hongying, Li, Chuan, Ali, Siraj M., Miller, Vincent A., Wu, Qiong·2022·Journal of Clinical Oncology
DOI 10.1200/jco.21.02641
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Abstract

PURPOSE: Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor approved in China. This double-blind phase III trial evaluated the efficacy and safety of aumolertinib compared with gefitinib as a first-line treatment for locally advanced or metastatic EGFR-mutated non–small-cell lung cancer (NSCLC; ClinicalTrials.gov identifier: NCT03849768 ). METHODS: Patients at 53 sites in China were randomly assigned 1:1 to receive either aumolertinib (110 mg) or gefitinib (250 mg) once daily. The primary end point was progression-free survival (PFS) per investigator assessment. RESULTS: A total of 429 patients who were naïve to treatment for locally advanced or metastatic NSCLC were enrolled. PFS was significantly longer with aumolertinib compared with gefitinib (hazard ratio, 0.46; 95% CI, 0.36 to 0.60; P < .0001). The median PFS with aumolertinib was 19.3 months (95% CI, 17.8 to 20.8) versus 9.9 months with gefitinib (95% CI, 8.3 to 12.6). Objective response rate and disease control rate were similar in the aumolertinib and gefitinib groups (objective response rate, 73.8% and 72.1%, respectively; disease control rate, 93.0% and 96.7%, respectively). The median duration of response was 18.1 months (95% CI, 15.2 to not applicable) with aumolertinib versus 8.3 months (95% CI, 6.9 to 11.1) with gefitinib. Adverse events of grade ≥ 3 severity (any cause) were observed in 36.4% and 35.8% of patients in the aumolertinib and gefitinib groups, respectively. Rash and diarrhea (any grade) were observed in 23.4% and 16.4% of patients who received aumolertinib compared with 41.4% and 35.8% of those who received gefitinib, respectively. CONCLUSION: Aumolertinib is a well-tolerated third-generation epidermal growth factor receptor tyrosine kinase inhibitor that could serve as a treatment option for EGFR-mutant NSCLC in the first-line setting.

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Metadata

Authors
Lu, S., Dong, X., Jian, H., Chen, J., Chen, G., Sun, Y., Ji, Y., Wang, Z., Shi, J., Lu, J., Chen, S., Lv, D., Zhang, G., Liu, C., Li, J., Yu, X., Lin, Z., Yu, Z., Wang, Z., Cui, J., Xu, X., Fang, J., Feng, J., Xu, Z., Ma, R., Hu, J., Yang, N., Zhou, X., Wu, X., Hu, C., Zhang, Z., Lu, Y., Hu, Y., Jiang, L., Wang, Q., Guo, R., Zhou, J., Li, B., Hu, C., Tong, W., Zhang, H., Ma, L., Chen, Y., Jie, Z., Yao, Y., Zhang, L., Jie, W., Li, W., Xiong, J., Ye, X., Duan, J., Yang, H., Sun, M., Sun, C., Wei, H., Li, C., Ali, S. M., Miller, V. A., & Wu, Q.
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2022-09-20
Volume
40
Issue
27
Pages
3162-3171
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.21.02641
OpenAlex
W4280558216
Cited by
303
References
11
FWCI
33.97
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or MetastaticNon–Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations. https://app.cochat.ai/papers/10.1200/jco.21.02641
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Lu, S., Dong, X., Jian, H., Chen, J., Chen, G., Sun, Y., Ji, Y., Wang, Z., Shi, J., Lu, J., Chen, S., Lv, D., Zhang, G., Liu, C., Li, J., Yu, X., Lin, Z., Yu, Z., Wang, Z., . . . Wu, Q. (2022). AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or MetastaticNon–Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations. Journal of Clinical Oncology. https://doi.org/10.1200/jco.21.02641

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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