{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T07:25:07Z","timestamp":1789457107985,"version":"build-2803163510"},"reference-count":42,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100008235","name":"Peking Union Medical College Hospital","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100008235","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Cancer Letters"],"published-print":{"date-parts":[[2025,10]]},"DOI":"10.1016\/j.canlet.2025.217904","type":"journal-article","created":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T20:36:00Z","timestamp":1751661360000},"page":"217904","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":7,"special_numbering":"C","title":["Efficacy and safety of sunvozertinib monotherapy as first-line treatment in NSCLC patients with EGFR exon 20 insertion mutations: A phase 2, single-center trial"],"prefix":"10.1016","volume":"630","author":[{"given":"Yan","family":"Xu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Minjiang","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoxing","family":"Gao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoyan","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Zhong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-8178-2755","authenticated-orcid":false,"given":"Mei","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongli","family":"Lang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7272-4997","authenticated-orcid":false,"given":"Chingwan","family":"Yip","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mengzhao","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.canlet.2025.217904_bib1","doi-asserted-by":"crossref","first-page":"220","DOI":"10.1158\/1535-7163.MCT-12-0620","article-title":"EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics","volume":"12","author":"Arcila","year":"2013","journal-title":"Mol. Cancer Therapeut."},{"key":"10.1016\/j.canlet.2025.217904_bib2","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1007\/s11523-022-00868-z","article-title":"Prevalence of epidermal growth factor receptor exon 20 insertion mutations in non-small-cell lung cancer in Europe: a pragmatic literature review and meta-analysis","volume":"17","author":"Van Sanden","year":"2022","journal-title":"Targeted Oncol."},{"key":"10.1016\/j.canlet.2025.217904_bib3","doi-asserted-by":"crossref","first-page":"1676","DOI":"10.1158\/2159-8290.CD-21-1615","article-title":"Sunvozertinib, a selective EGFR inhibitor for previously treated non-small cell lung cancer with EGFR Exon 20 insertion mutations","volume":"12","author":"Wang","year":"2022","journal-title":"Cancer Discov."},{"key":"10.1016\/j.canlet.2025.217904_bib4","doi-asserted-by":"crossref","DOI":"10.1126\/scitranslmed.3007205","article-title":"Structural, biochemical, and clinical characterization of epidermal growth factor receptor (EGFR) exon 20 insertion mutations in lung cancer","volume":"5","author":"Yasuda","year":"2013","journal-title":"Sci. Transl. Med."},{"key":"10.1016\/j.canlet.2025.217904_bib5","doi-asserted-by":"crossref","first-page":"S208","DOI":"10.1016\/j.jtho.2021.01.112","article-title":"Underdiagnosis of EGFR Exon20 insertion mutation variants: estimates from NGS-based real-world datasets","volume":"16","author":"Bauml","year":"2021","journal-title":"J. Thorac. Oncol."},{"issue":"8","key":"10.1016\/j.canlet.2025.217904_bib6","doi-asserted-by":"crossref","first-page":"1695","DOI":"10.1002\/1878-0261.12710","article-title":"Variability of EGFR exon 20 insertions in 24 468 Chinese lung cancer patients and their divergent responses to EGFR inhibitors","volume":"14","author":"Qin","year":"2020","journal-title":"Mol. Oncol."},{"issue":"7878","key":"10.1016\/j.canlet.2025.217904_bib7","doi-asserted-by":"crossref","first-page":"732","DOI":"10.1038\/s41586-021-03898-1","article-title":"Structure-based classification predicts drug response in EGFR-mutant NSCLC","volume":"597","author":"Robichaux","year":"2021","journal-title":"Nature"},{"issue":"4S","key":"10.1016\/j.canlet.2025.217904_bib8","article-title":"Real-world frequency of non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations by site of insertion","volume":"16","author":"Viteri","year":"2021","journal-title":"J. Thorac. Oncol."},{"issue":"1","key":"10.1016\/j.canlet.2025.217904_bib9","doi-asserted-by":"crossref","DOI":"10.1038\/s41598-021-98275-3","article-title":"Clinical characteristics of advanced non-small cell lung cancer patients with EGFR exon 20 insertions","volume":"11","author":"Morita","year":"2021","journal-title":"Sci. Rep."},{"issue":"3","key":"10.1016\/j.canlet.2025.217904_bib10","doi-asserted-by":"crossref","first-page":"217","DOI":"10.1016\/S2213-2600(23)00379-X","article-title":"Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial","volume":"12","author":"Wang","year":"2024","journal-title":"Lancet Respir. Med."},{"issue":"30","key":"10.1016\/j.canlet.2025.217904_bib11","doi-asserted-by":"crossref","first-page":"3391","DOI":"10.1200\/JCO.21.00662","article-title":"Amivantamab in EGFR Exon 20 insertion-mutated non-small-cell lung cancer progressing on platinum chemotherapy: initial results from the CHRYSALIS phase I study","volume":"39","author":"Park","year":"2021","journal-title":"J. Clin. Oncol."},{"issue":"22","key":"10.1016\/j.canlet.2025.217904_bib12","doi-asserted-by":"crossref","first-page":"2039","DOI":"10.1056\/NEJMoa2306441","article-title":"Amivantamab plus chemotherapy in NSCLC with EGFR Exon 20 insertions","volume":"389","author":"Zhou","year":"2023","journal-title":"N. Engl. J. Med."},{"issue":"13","key":"10.1016\/j.canlet.2025.217904_bib13","doi-asserted-by":"crossref","first-page":"1553","DOI":"10.1200\/JCO-24-01269","article-title":"First-Line mobocertinib versus platinum-based chemotherapy in patients with EGFR Exon 20 insertion\u2013positive metastatic non\u2013small cell lung cancer in the phase III EXCLAIM-2 trial","volume":"43","author":"J\u00e4nne","year":"2025","journal-title":"J. Clin. Oncol."},{"issue":"7","key":"10.1016\/j.canlet.2025.217904_bib14","doi-asserted-by":"crossref","first-page":"1676","DOI":"10.1158\/2159-8290.CD-21-1615","article-title":"Sunvozertinib, a selective EGFR inhibitor for previously treated non-small cell lung cancer with EGFR Exon 20 insertion mutations","volume":"12","author":"Wang","year":"2022","journal-title":"Cancer Discov."},{"key":"10.1016\/j.canlet.2025.217904_bib15","doi-asserted-by":"crossref","first-page":"8513","DOI":"10.1200\/JCO.2024.42.16_suppl.8513","article-title":"A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon 20 insertion mutations: primary analysis of WU-KONG1 study","volume":"42","author":"Yang","year":"2024","journal-title":"J. Clin. Oncol."},{"issue":"2","key":"10.1016\/j.canlet.2025.217904_bib16","article-title":"Sunvozertinibas first-line treatment in NSCLC patients with EGFRExon20 insertion mutations","volume":"34","author":"Yang","year":"2023","journal-title":"Ann. Oncol."},{"key":"10.1016\/j.canlet.2025.217904_bib17","doi-asserted-by":"crossref","DOI":"10.1016\/j.lungcan.2024.108053","article-title":"Sunvozertinib monotherapy in EGFR tyrosine kinase inhibitor-resistant non-small cell lung cancer with EGFR mutations","volume":"199","author":"Wang","year":"2025","journal-title":"Lung Cancer"},{"issue":"2","key":"10.1016\/j.canlet.2025.217904_bib18","doi-asserted-by":"crossref","first-page":"357","DOI":"10.1200\/JCO.2009.24.7049","article-title":"Clinical definition of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer","volume":"28","author":"Jackman","year":"2010","journal-title":"J. Clin. Oncol."},{"key":"10.1016\/j.canlet.2025.217904_bib19","doi-asserted-by":"crossref","first-page":"73","DOI":"10.1186\/s12916-023-02768-z","article-title":"Rare mutation-dominant compound EGFR-positive NSCLC is associated with enriched kinase domain-resided variants of uncertain significance and poor clinical outcomes","volume":"21","author":"Zhao","year":"2023","journal-title":"BMC Med."},{"issue":"7689","key":"10.1016\/j.canlet.2025.217904_bib20","doi-asserted-by":"crossref","first-page":"446","DOI":"10.1038\/nature25183","article-title":"The biology and management of non-small cell lung cancer","volume":"553","author":"Herbst","year":"2018","journal-title":"Nature"},{"key":"10.1016\/j.canlet.2025.217904_bib21","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1016\/j.lungcan.2020.03.014","article-title":"EGFR exon 20 insertion mutations in Chinese advanced non-small cell lung cancer patients: molecular heterogeneity and treatment outcome from nationwide real-world study","volume":"145","author":"Yang","year":"2020","journal-title":"Lung Cancer"},{"key":"10.1016\/j.canlet.2025.217904_bib22","doi-asserted-by":"crossref","first-page":"154","DOI":"10.1016\/j.lungcan.2021.10.020","article-title":"Comparative clinical outcomes for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations","volume":"162","author":"Bazhenova","year":"2021","journal-title":"Lung Cancer"},{"key":"10.1016\/j.canlet.2025.217904_bib23","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1016\/j.lungcan.2020.11.027","article-title":"Osimertinib for Chinese advanced non-small cell lung cancer patients harboring diverse EGFR exon 20 insertion mutations","volume":"152","author":"Yang","year":"2021","journal-title":"Lung Cancer"},{"key":"10.1016\/j.canlet.2025.217904_bib24","doi-asserted-by":"crossref","first-page":"133","DOI":"10.1016\/j.lungcan.2022.06.012","article-title":"High dose osimertinib in patients with advanced stage EGFR exon 20 mutation-positive NSCLC: results from the phase 2 multicenter POSITION20 trial","volume":"170","author":"Zwierenga","year":"2022","journal-title":"Lung Cancer"},{"issue":"7","key":"10.1016\/j.canlet.2025.217904_bib25","doi-asserted-by":"crossref","first-page":"754","DOI":"10.1016\/j.ccell.2022.06.006","article-title":"Poziotinib for EGFR exon 20-mutant NSCLC: clinical efficacy, resistance mechanisms, and impact of insertion location on drug sensitivity","volume":"40","author":"Elamin","year":"2022","journal-title":"Cancer Cell"},{"issue":"7","key":"10.1016\/j.canlet.2025.217904_bib26","doi-asserted-by":"crossref","first-page":"1672","DOI":"10.1158\/2159-8290.CD-20-1683","article-title":"Mobocertinib (TAK-788): a targeted inhibitor of EGFR Exon 20 insertion mutants in non-small cell lung cancer","volume":"11","author":"Gonzalvez","year":"2021","journal-title":"Cancer Discov."},{"issue":"26","key":"10.1016\/j.canlet.2025.217904_bib27","doi-asserted-by":"crossref","first-page":"4218","DOI":"10.1200\/JCO.23.00152","article-title":"Safety, tolerability, and antitumor activity of zipalertinib among patients with non-small-cell lung cancer harboring epidermal growth factor receptor Exon 20 insertions","volume":"41","author":"Piotrowska","year":"2023","journal-title":"J. Clin. Oncol."},{"issue":"2","key":"10.1016\/j.canlet.2025.217904_bib28","doi-asserted-by":"crossref","first-page":"314","DOI":"10.1016\/j.jtho.2023.09.1449","article-title":"Safety, tolerability, pharmacokinetics, and preliminary efficacy of YK-029A in treatment-naive patients with advanced NSCLC harboring EGFR Exon 20 insertion mutations: a phase 1 trial","volume":"19","author":"Duan","year":"2024","journal-title":"J. Thorac. Oncol."},{"issue":"2","key":"10.1016\/j.canlet.2025.217904_bib29","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1056\/NEJMoa1713137","article-title":"Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer","volume":"378","author":"Soria","year":"2018","journal-title":"N. Engl. J. Med."},{"issue":"7","key":"10.1016\/j.canlet.2025.217904_bib30","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1056\/NEJMoa1612674","article-title":"Osimertinib or platinum-pemetrexed in EGFR T790M-Positive lung cancer","volume":"376","author":"Mok","year":"2017","journal-title":"N. Engl. J. Med."},{"issue":"6","key":"10.1016\/j.canlet.2025.217904_bib31","article-title":"High-dose osimertinib for CNS progression in EGFR+ NSCLC: a multi-institutional experience","volume":"3","author":"Piper-Vallillo","year":"2022","journal-title":"JTO Clin. Res. Rep."},{"issue":"5","key":"10.1016\/j.canlet.2025.217904_bib32","article-title":"Genetic biomarker study of sunvozertinib for clinical prognosis and prediction in NSCLC with EGFR exon 20 insertion mutation","volume":"6","author":"Xu","year":"2025","journal-title":"Cell Rep. Med."},{"issue":"1","key":"10.1016\/j.canlet.2025.217904_bib33","doi-asserted-by":"crossref","first-page":"4","DOI":"10.21037\/tlcr-21-754","article-title":"TP53 co-mutations as an independent prognostic factor in 2nd and further line therapy-EGFR mutated non-small cell lung cancer IV patients treated with osimertinib","volume":"11","author":"Roeper","year":"2022","journal-title":"Transl. Lung Cancer Res."},{"issue":"2","key":"10.1016\/j.canlet.2025.217904_bib34","doi-asserted-by":"crossref","first-page":"100","DOI":"10.1016\/j.cllc.2020.11.001","article-title":"Predictive and prognostic potential of TP53 in patients with advanced non-small-cell lung cancer treated with EGFR-TKI: analysis of a phase III randomized clinical trial (CTONG 0901)","volume":"22","author":"Li","year":"2021","journal-title":"Clin. Lung Cancer"},{"issue":"1","key":"10.1016\/j.canlet.2025.217904_bib35","doi-asserted-by":"crossref","DOI":"10.1038\/s41598-021-99267-z","article-title":"Contribution of p53 in sensitivity to EGFR tyrosine kinase inhibitors in non-small cell lung cancer","volume":"11","author":"Jung","year":"2021","journal-title":"Sci. Rep."},{"key":"10.1016\/j.canlet.2025.217904_bib36","doi-asserted-by":"crossref","DOI":"10.1016\/j.canlet.2023.216587","article-title":"USP7-mediated ER\u03b2 stabilization mitigates ROS accumulation and promotes osimertinib resistance by suppressing PRDX3 SUMOylation in non-small cell lung carcinoma","volume":"582","author":"Meng","year":"2024","journal-title":"Cancer Lett."},{"key":"10.1016\/j.canlet.2025.217904_bib37","doi-asserted-by":"crossref","DOI":"10.1016\/j.canlet.2024.216762","article-title":"Sialyltransferase ST3GAL4 confers osimertinib resistance and offers strategies to overcome resistance in non-small cell lung cancer","volume":"588","author":"Han","year":"2024","journal-title":"Cancer Lett."},{"key":"10.1016\/j.canlet.2025.217904_bib38","doi-asserted-by":"crossref","DOI":"10.1016\/j.canlet.2024.217124","article-title":"Triple combination therapy comprising osimertinib, an AXL inhibitor, and an FGFR inhibitor improves the efficacy of EGFR-mutated non-small cell lung cancer","volume":"598","author":"Nakamura","year":"2024","journal-title":"Cancer Lett."},{"issue":"20","key":"10.1016\/j.canlet.2025.217904_bib39","doi-asserted-by":"crossref","first-page":"1297","DOI":"10.21037\/atm-20-6172","article-title":"Tumor genomics and response to chemotherapy in advanced non-small cell lung cancer with exon 20 insertion epidermal growth factor receptor mutations","volume":"8","author":"Wang","year":"2020","journal-title":"Ann. Transl. Med."},{"issue":"10","key":"10.1016\/j.canlet.2025.217904_bib40","doi-asserted-by":"crossref","first-page":"2920","DOI":"10.1158\/1078-0432.CCR-20-4650","article-title":"Response to standard therapies and comprehensive genomic analysis for patients with lung adenocarcinoma with EGFR Exon 20 insertions","volume":"27","author":"Choudhury","year":"2021","journal-title":"Clin. Cancer Res."},{"issue":"8","key":"10.1016\/j.canlet.2025.217904_bib41","doi-asserted-by":"crossref","first-page":"1341","DOI":"10.1080\/03007995.2022.2083326","article-title":"Non-small cell lung cancer with EGFR exon 20 insertion mutation: a systematic literature review and meta-analysis of patient outcomes","volume":"38","author":"Kwon","year":"2022","journal-title":"Curr. Med. Res. Opin."},{"key":"10.1016\/j.canlet.2025.217904_bib42","doi-asserted-by":"crossref","first-page":"1935","DOI":"10.1056\/NEJMoa2306434","article-title":"Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC","volume":"389","author":"Planchard","year":"2023","journal-title":"N. Engl. J. Med."}],"container-title":["Cancer Letters"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0304383525004720?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0304383525004720?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T23:00:40Z","timestamp":1760742040000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0304383525004720"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10]]},"references-count":42,"alternative-id":["S0304383525004720"],"URL":"https:\/\/doi.org\/10.1016\/j.canlet.2025.217904","relation":{},"ISSN":["0304-3835"],"issn-type":[{"value":"0304-3835","type":"print"}],"subject":[],"published":{"date-parts":[[2025,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Efficacy and safety of sunvozertinib monotherapy as first-line treatment in NSCLC patients with EGFR exon 20 insertion mutations: A phase 2, single-center trial","name":"articletitle","label":"Article Title"},{"value":"Cancer Letters","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.canlet.2025.217904","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"217904"}}