{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T20:33:27Z","timestamp":1765830807428,"version":"3.48.0"},"reference-count":13,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T00:00:00Z","timestamp":1745884800000},"content-version":"unspecified","delay-in-days":28,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"the Key Special Projects of the \"14th Five-Year Plan\u201d the National Key R & D Program of China","award":["2023YFC2508604"],"award-info":[{"award-number":["2023YFC2508604"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,4,7]]},"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Targeted therapy is now the standard treatment for patients with epidermal growth factor receptor (EGFR) mutations, yet resistance continues to be a significant challenge. Enhancing the efficacy of targeted therapies and prolonging patient survival remain critical clinical priorities. Although combining third-generation EGFR tyrosine kinase inhibitors (TKIs) with intravenous chemotherapy has demonstrated promising results, it is unclear if oral chemotherapy regimens combined with EGFR TKIs could also improve survival outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>EVOLUTION is a multicentre, phase II clinical trial conducted across three tertiary hospitals in China: Shanghai Pulmonary Hospital (lead centre), Zhongshan Hospital Affiliated to Fudan University and Shanghai Fifth People\u2019s Hospital Affiliated to Fudan University. The study will enrol 60 patients with locally advanced or metastatic lung cancer harbouring EGFR-sensitive mutations who have not previously undergone systemic therapy. Participants will be administered a combination regimen of aumolertinib (110\u2009mg orally, once a day in a 28-day cycle, continuously) and Lastet (25\u2009mg orally, administered in a 28-day cycle, with 2\u2009weeks on followed by 2\u2009weeks off). The primary endpoint is progression-free survival, and the secondary endpoints are overall survival, objective response rate, disease control rate and duration of response. Tumour response will be assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors 1.1. Patient enrolment is currently underway.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval for this study was granted by the Ethics Committee of Shanghai Pulmonary Hospital in April 2024 (approval number: L23-334). Patients will participate after providing informed consent. The results of the study will be disseminated through peer-reviewed journals and presentations at academic conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06463171\">NCT06463171<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-097576","type":"journal-article","created":{"date-parts":[[2025,4,30]],"date-time":"2025-04-30T02:36:13Z","timestamp":1745980573000},"page":"e097576","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Aumolertinib in combination with Lastet in the first-line treatment of EGFR-mutated, locally advanced or metastatic non-small cell lung cancer 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