{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T18:28:12Z","timestamp":1787164092655,"version":"build-2736575974"},"reference-count":22,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Although EGFR-TKIs have substantially improved outcomes in EGFR-mutated advanced NSCLC, acquired resistance ultimately leads to treatment failure in most patients. Yifeixiaoji Decoction (YFXJD), a traditional Chinese herbal formulation, has shown promise as an adjunctive strategy; however, evidence from prospective clinical studies for this specific formula remains limited. We therefore designed this trial to assess whether YFXJD could prolong progression-free survival when added to standard osimertinib therapy in advanced NSCLC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A total of 200 patients with stage IV EGFR-mutant NSCLC will be enrolled in a randomized, double-blind, placebo-controlled trial and allocated 1:1 to receive standard osimertinib therapy combined with either YFXJD granules or matched placebo. The primary endpoints is progression-free survival. Key secondary endpoints include change in TCM syndrome score, objective response rate, quality of life (EORTC QLQ-C30\/LC13), safety (NCI CTCAE v5.0), and exploratory peripheral blood biomarker analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Expected results<\/jats:title>\n                    <jats:p>This trial will provide prospective evidence regarding the efficacy and safety of YFXJD as an adjunct to osimertinib therapy in patients with advanced EGFR-mutant NSCLC and will determine whether this approach influences clinical outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>https:\/\/itmctr.ccebtcm.org.cn<\/jats:ext-link>\n                      , ITMCTR2025002306.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1890856","type":"journal-article","created":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:37:59Z","timestamp":1787031479000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Yifeixiaoji decoction as an adjunct to osimertinib therapy in advanced EGFR-mutated NSCLC: protocol for a randomized, double-blind, placebo-controlled trial"],"prefix":"10.3389","volume":"13","author":[{"given":"Qiuting","family":"Feng","sequence":"first","affiliation":[{"name":"Department of Oncology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine","place":["Shanghai, China"]},{"name":"Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine","place":["Shanghai, China"]},{"name":"Oncology Department of Traditional Chinese Medicine, The First Affiliated Hospital of Naval 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