{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,9]],"date-time":"2026-11-09T21:00:59Z","timestamp":1794258059822,"version":"4.9.0"},"reference-count":31,"publisher":"American Medical Association (AMA)","issue":"8","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Oncol"],"published-print":{"date-parts":[[2025,8,1]]},"abstract":"\n Importance<\/jats:title>\n \n Central nervous system (CNS) metastases remain a significant challenge in the management of\n EGFR<\/jats:italic>\n -variant non\u2013small cell lung cancer (NSCLC).\n <\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n \n To evaluate the activity and safety of high-dose aumolertinib in patients with untreated\n EGFR<\/jats:italic>\n -variant NSCLC and brain metastases.\n <\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n \n This was a phase 2 nonrandomized clinical trial conducted at 10 centers in China. Patients with untreated\n EGFR<\/jats:italic>\n -variant metastatic NSCLC and brain metastases were enrolled between July 6, 2021, and August 31, 2022. The data cutoff date was October 10, 2024.\n <\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Patients received aumolertinib, 165 mg, orally once daily until disease progression or unacceptable toxic effects.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary end point was 12-month progression-free survival (PFS) rate assessed by investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 63 patients (39 female [61.9%]; median age, 60 [range, 47-76] years) were enrolled (full analysis set), and 49 had at least 1 measurable brain lesion (CNS evaluable-for-response set). Median follow-up duration was 28.8 months (95% CI, 27.0-29.8). In the full analysis set, the 12-month PFS rate was 62.1% (95% CI, 48.7-73.0), the median PFS was 20.5 months (95% CI, 12.0-26.9), the 12-month intracranial PFS rate was 76.8% (95% CI, 63.2-85.9), and the median intracranial PFS and overall survival were not reached. Systemic and intracranial objective response rates per RECIST 1.1 were 56 of 63 (88.9% [95% CI, 78.4-95.4]) and 52 of 63 (82.5% [95% CI, 70.9-90.9]) in the full analysis set and 43 of 49 (87.8% [95% CI, 75.2-95.4]) and 42 of 49 (85.7% [95% CI, 72.8-94.1]) in the CNS evaluable-for-response set, respectively. The most common grade 3 or 4 treatment-related adverse event was increased blood creatine phosphokinase (17 participants [27.0%]). No treatment-related deaths occurred.\n EGFR<\/jats:italic>\n variant clearance in plasma circulating tumor DNA at day 1 of cycle 2 was independently associated with longer PFS (hazard ratio, 0.14 [95% CI, 0.04-0.47];\n P<\/jats:italic>\n \u2009=\u2009.001).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n \n The findings of this nonrandomized clinical trial suggest that high-dose aumolertinib is associated with long-term survival benefit in patients with untreated\n EGFR<\/jats:italic>\n -variant NSCLC and brain metastases, with a manageable safety profile.\n <\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT04808752<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamaoncol.2025.1779","type":"journal-article","created":{"date-parts":[[2025,6,26]],"date-time":"2025-06-26T11:31:00Z","timestamp":1750937460000},"page":"900","source":"Crossref","is-referenced-by-count":11,"title":["High-Dose 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