{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T15:52:19Z","timestamp":1791388339649,"version":"4.3.3"},"reference-count":35,"publisher":"American Medical Association (AMA)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2026,9,8]]},"abstract":"\n Importance<\/jats:title>\n \n Combination therapy has emerged as a promising therapeutic approach for patients with epidermal growth factor receptor (\n EGFR<\/jats:italic>\n )\u2013mutated non\u2013small cell lung cancer (NSCLC). However, its clinical benefit-risk profile remains a focus of ongoing debate. Identifying patients most likely to derive benefit from such regimens remains an unmet clinical need.\n <\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n \n To prospectively compare the efficacy and safety of first-line osimertinib plus chemotherapy with osimertinib monotherapy for patients with\n EGFR<\/jats:italic>\n -mutated advanced NSCLC harboring concurrent\n TP53<\/jats:italic>\n mutations.\n <\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n \n A multicenter, randomized, open-label, phase 3 study conducted at 17 sites in China. Between March 25, 2021, and July 11, 2024, a total of 294 eligible patients with treatment-naive, stage IV or recurrent nonsquamous NSCLC harboring concurrent\n TP53<\/jats:italic>\n and\n EGFR<\/jats:italic>\n -sensitizing mutations were enrolled.\n <\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Patients were randomized (1:1) to receive osimertinib plus chemotherapy (pemetrexed and carboplatin every 3 weeks for 4 cycles, followed by maintenance therapy of osimertinib plus pemetrexed; n\u2009=\u2009146) or osimertinib monotherapy (n\u2009=\u2009148).<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary end point was investigator-assessed progression-free survival. Secondary end points included overall survival, response, safety, and quality of life.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Among 294 enrolled patients, the median age was 57 years (range, 26-79 years), and 159 (54.1%) were female. The data cutoff date was November 11, 2025. At a median follow-up of 25.1 months for the osimertinib-chemotherapy group and 26.1 months for the osimertinib monotherapy group, median progression-free survival was significantly longer with osimertinib plus chemotherapy than with osimertinib monotherapy (34.0 vs 15.6 months; difference, 18.4 months [95% CI, 9.9-22.3]; hazard ratio, 0.44 [95% CI, 0.32-0.60];\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). This benefit was consistent across prespecified subgroups, including those with brain metastases and\n L858R<\/jats:italic>\n mutations. The overall survival data remained immature (30.6% maturity); however, a trend toward overall survival benefit with combination therapy was observed. The incidence of grade 3 or higher treatment-related adverse events was higher in the combination group, with no new safety signal identified.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n \n In this randomized clinical trial, osimertinib plus chemotherapy significantly increased progression-free survival among patients with\n EGFR<\/jats:italic>\n -mutated advanced NSCLC harboring concurrent\n TP53<\/jats:italic>\n mutations. These findings provided a clinical rationale for individualized combination strategies in the management of patients with\n EGFR<\/jats:italic>\n -mutated NSCLC.\n <\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT04695925<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2026.10599","type":"journal-article","created":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T15:30:26Z","timestamp":1786375826000},"page":"838","source":"Crossref","is-referenced-by-count":3,"title":["Osimertinib With or Without Chemotherapy in Advanced Non\u2013Small Cell Lung Cancer With\n EGFR<\/i>\n and Concurrent\n TP53<\/i>\n Mutations"],"prefix":"10.1001","volume":"336","author":[{"given":"Ting","family":"Zhou","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong 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