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Forty patients with EGFR-mutated resectable disease will receive BL-B01D1 plus aumolertinib prior to surgery, followed by aumolertinib adjuvantly post-surgery. The primary endpoints are pathological complete response and major pathological response at resection, with efficacy and biomarker and safety assessments.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/a-study-protocol-of-a-single-arm-prospective-open-label-noncontrolled-phase-ii-study-of-neoadjuvant-bl-b01d1-combined-with-aumolertinib-in-resectable-stage-iiiiib-non-small-cell-lung-cancer-patients-with-egfr-mutation/448146/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/a-study-protocol-of-a-single-arm-prospective-open-label-noncontrolled-phase-ii-study-of-neoadjuvant-bl-b01d1-combined-with-aumolertinib-in-resectable-stage-iiiiib-non-small-cell-lung-cancer-patients-with-egfr-mutation/448146.png","ImageObject",300,407,{"name":92,"@type":93},"Oliver","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is the primary objective of this phase II study?","Question",{"text":112,"@type":113},"To evaluate the effectiveness and safety of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II–IIIB NSCLC patients with EGFR mutation.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What treatment schedule will participants follow?",{"text":117,"@type":113},"Patients will receive BL-B01D1 plus aumolertinib before surgery, then receive aumolertinib as adjuvant treatment after surgery.",{"name":119,"@type":110,"acceptedAnswer":120},"What are the primary and secondary endpoints?",{"text":121,"@type":113},"Primary endpoints are pathological complete response and major pathological response at resection; secondary endpoints include objective response rate, event-free survival, disease-free survival, overall survival, and R0 resection rate.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},448146,1790795592,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":39,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":46,"preview_page_count":4},8796095461610,"https://ap-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","A study protocol of a single-arm, prospective, open-label, noncontrolled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II–IIIB non-small cell lung cancer patients with EGFR mutation  \nYue Chen1\\#, Jiandong Mei2,3\\#, Ge Gao1, Benxia Zhang1, Yanying Li4, Zhiyu Peng2,3, Chuan Li2,3, Fanyi Gan2,3, Qiang Pu2,3, Chengwu Liu2,3, Wenjie Yang5, Lunxu Liu2,3, Yongsheng Wang4  \n1Clinical Trial Center, West China Hospital, Sichuan University, Chengdu, China; 2Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, China; 3Western China Collaborative Innovation Center for Early Diagnosis and Multidisciplinary Therapy of Lung Cancer, Sichuan University, Chengdu, China; 4Division of Thoracic Tumor Multimodality Treatment, Cancer Center, West China Hospital, Sichuan University, Chengdu, China; 5Center of Biostatistics, Design, Measurement and Evaluation (CBDME), West China Hospital, Sichuan University, Chengdu, China  \nContributions: (I) Conception and design: Y Wang, J Mei, Y Chen; (II) Administrative support: L Liu; (III) Provision of study materials or patients: Y Wang, Y Li, J Mei, L Liu; (IV) Collection and assembly of data: Y Chen, G Gao, B Zhang; (V) Data analysis and interpretation: Y Chen; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.  \n\\#These authors contributed equally to this work.  \nCorrespondence to: Lunxu Liu, MD. Department of Thoracic Surgery, West China Hospital, Sichuan University, No. 37 Guoxue Alley, Chengdu 610041, China; Western China Collaborative Innovation Center for Early Diagnosis and Multidisciplinary Therapy of Lung Cancer, Sichuan University, Chengdu, China. Email: [lunxu_liu@aliyun.com](lunxu_liu@aliyun.com); Yongsheng Wang, MD. Division of Thoracic Tumor Multimodality Treatment, Cancer  \nCenter, West China Hospital, Sichuan University, No. 37 Guoxue Alley, Chengdu 610041, [China. Email: wangys@scu.edu.cn](China. Email: wangys@scu.edu.cn).  \nBackground: Current neoadjuvant strategies for resectable epidermal growth factor receptor (EGFR) -mutation non-small cell lung cancer (NSCLC) yield suboptimal pathological responses, highlighting an unmet need for biologically targeted approaches. This study aimed to evaluate the effectiveness and safety of neoadjuvant BL-B01D1, a first-in-class EGFR/human EGFR 3 (HER3) bispecific antibody-drug conjugate combined with aumolertinib, a third EGFR-tyrosine kinase inhibitor, in individuals with resectable stage II–  \nIIIB NSCLC harboring EGFR mutation.  \nMethods: This phase II, open-label, non-controlled, single-arm, dose escalation and dose expansion study will recruit 40 stage II–IIIB resectable NSCLC patients with EGFR mutation. The study will evaluate the efficacy and safety of neoadjuvant therapy combining BL-B01D1 with aumolertinib prior to surgery and aumolertinib adjuvant treatment post-surgery. The primary endpoint is pathological complete response and major pathological response at the time of resection. Secondary end points include objective response rate, event-free survival, disease-free survival, overall survival, and R0 resection rate in the neoadjuvant setting.  \nSafety, tolerability and biomarkers will also be assessed.  \nDiscussion: This protocol describes the methodology of study in order to identify neoadjuvant therapy of  \nBL-B01D1 and aumolertinib for resectable stage II–IIIB NSCLC with EGFR mutation.  \nTrial Registration: [Clinicaltrials.gov](Clinicaltrials.gov) identifier: NCT06951464 . Registered on April 23, 2025. Protocol  \nversion: version 2.0, May 06, 2025.  \nKeywords: Epidermal growth factor receptor (EGFR); neoadjuvant; non-small-cell lung cancer (NSCLC); BL  \nB01D1; aumolertinib  \nSubmitted Jul 18, 2025. Accepted for publication Nov 12, 2025. Published online Dec 17, 2025.  \ndoi: 10.21037/tlcr-2025-829  \nView this article at: [https://dx.doi.org/10.21037/tlcr-2025-829](https://dx.doi.org/10.21037/tlcr-2025-829)  \n© AME Publishing Company.","cbCaiqZ9kvCSm0ml","https://ap.wps.com/l/cbCaiqZ9kvCSm0ml","pdf",232513,"English","# Background\n# Methods\n# Discussion\n# Trial Registration","[{\"question\":\"What is the primary objective of this phase II study?\",\"answer\":\"To evaluate the effectiveness and safety of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II–IIIB NSCLC patients with EGFR mutation.\"},{\"question\":\"What treatment schedule will participants follow?\",\"answer\":\"Patients will receive BL-B01D1 plus aumolertinib before surgery, then receive aumolertinib as adjuvant treatment after surgery.\"},{\"question\":\"What are the primary and secondary endpoints?\",\"answer\":\"Primary endpoints are pathological complete response and major pathological response at resection; secondary endpoints include objective response rate, event-free survival, disease-free survival, overall survival, and R0 resection rate.\"}]","A study protocol of a single-arm, prospective, open-label, noncontrolled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II–IIIB non-small cell lung cancer patients with EGFR mutation | PDF",1790725716]