{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T12:52:36Z","timestamp":1793969556906,"version":"4.8.0"},"reference-count":30,"publisher":"BMJ","license":[{"start":{"date-parts":[[2025,6,5]],"date-time":"2025-06-05T00:00:00Z","timestamp":1749081600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ"],"accepted":{"date-parts":[[2025,5,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>\n                      To compare the efficacy and safety of sacituzumab tirumotecan (sac-TMT) with docetaxel in patients with locally advanced or metastatic epidermal growth factor receptor (\n                      <jats:italic>EGFR)<\/jats:italic>\n                      -mutated non-small cell lung cancer (NSCLC) after previous treatment failure with EGFR-tyrosine kinase inhibitors and platinum based chemotherapy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Multicentre, open label, randomised controlled trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>48 centres in China, 1 September 2023 to 31 December 2024.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>\n                      137 adults (aged 18-75 years) with\n                      <jats:italic>EGFR<\/jats:italic>\n                      -mutated advanced or metastatic NSCLC after previous treatment failure with EGFR-tyrosine kinase inhibitors and platinum based chemotherapy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>\n                      Patients were randomly assigned (2:1) to receive sac-TMT (5 mg\/kg) on days 1 and 15 of each four week cycle, or docetaxel (75 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ) on day 1 of each three week cycle. Patients in the docetaxel group were permitted to crossover to sac-TMT treatment on disease progression.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>The primary endpoint was objective response rate as assessed by a blinded independent review committee (BIRC). The secondary endpoints included objective response rate assessed by the investigator; disease control rate, progression-free survival, time to response, and duration of response assessed by BIRC and the investigator; overall survival; and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      137 patients were randomised to receive sac-TMT (n=91) or docetaxel (n=46). Median follow-up was 12.2 months at the data cut-off for efficacy (31 December 2024). BIRC assessed objective response rate was significantly higher in the sac-TMT group (45% (41\/91))\n                      <jats:italic>v<\/jats:italic>\n                      docetaxel (16% (7\/45)), with a difference of 29% (95% confidence interval (CI) 15% to 43%; one sided P&lt;0.001). Median progression-free survival was longer with sac-TMT than with docetaxel assessed by BIRC (6.9\n                      <jats:italic>v<\/jats:italic>\n                      2.8 months; hazard ratio 0.30, 95% CI 0.20 to 0.46; one sided P&lt;0.001) and the investigator (7.9\n                      <jats:italic>v<\/jats:italic>\n                      2.8 months; hazard ratio 0.23, 0.15 to 0.36; one sided P&lt;0.001). The 12 month overall survival rate was 73% with sac-TMT and 54% with docetaxel (hazard ratio 0.49, 0.27 to 0.88; one sided P=0.007). After adjustment for crossover using the rank-preserving structural failure time model, sac-TMT also showed improved overall survival (hazard ratio 0.36, 0.20 to 0.66). Grade \u22653 treatment related adverse events were less frequent with sac-TMT than with docetaxel (56%\n                      <jats:italic>v<\/jats:italic>\n                      72%), with no new safety signals identified.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Sac-TMT showed statistically significant and clinically meaningful improvements in objective response rate, progression-free survival, and overall survival compared with docetaxel, with a manageable safety profile in patients with\n                      <jats:italic>EGFR<\/jats:italic>\n                      -mutated locally advanced or metastatic NSCLC.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT05631262\" ext-link-type=\"clintrialgov\">NCT05631262<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmj-2025-085680","type":"journal-article","created":{"date-parts":[[2025,6,5]],"date-time":"2025-06-05T12:05:11Z","timestamp":1749125111000},"page":"e085680","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":55,"title":["Sacituzumab tirumotecan versus docetaxel for previously treated\n                    <i>EGFR<\/i>\n                    -mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial"],"prefix":"10.1136","volume":"389","clinical-trial-number":[{"clinical-trial-number":"nct05631262","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05631262","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05870319","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06074588","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06305754","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Wenfeng","family":"Fang","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Provincial Clinical Research Centre for Cancer, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xingya","family":"Li","sequence":"additional","affiliation":[{"name":"Oncology Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiming","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China"},{"name":"Institute of Cancer Research, Henan Academy of Innovations in Medical Science, Zhengzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangjiao","family":"Meng","sequence":"additional","affiliation":[{"name":"Department of Thoracic Radiotherapy, Shandong Cancer Hospital and Institute, Shandong First Medical University, Jinan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Zheng","sequence":"additional","affiliation":[{"name":"Oncology Department, Shengjing Hospital of China Medical University, Shenyang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Longhua","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenxiu","family":"Yao","sequence":"additional","affiliation":[{"name":"Department of Thoracic Medical Oncology, Sichuan Cancer Hospital, Chengdu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wu","family":"Zhuang","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yun","family":"Fan","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, 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TROP2-ADC SKB264 (sac-TMT) Third NDA for EGFR-mutant NSCLC Accepted by NMPA 2024. 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