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

Sep 29, 2026

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A single-arm, prospective, open-label, non-controlled phase II study evaluates neoadjuvant BL-B01D1, an EGFR/HER3 bispecific antibody-drug conjugate, combined with aumolertinib in resectable stage II–IIIB non-small cell lung cancer patients with EGFR mutation. 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.

LanguageEnglish

CategoryHealthcare

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Pages8

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Background

Methods

Discussion

Trial Registration

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 Yue 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 1Clinical 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 Contributions: (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. \#These authors contributed equally to this work. Correspondence 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 Center, West China Hospital, Sichuan University, No. 37 Guoxue Alley, Chengdu 610041, [China. Email: wangys@scu.edu.cn](China. Email: wangys@scu.edu.cn). Background: 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– IIIB NSCLC harboring EGFR mutation. Methods: 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. Safety, tolerability and biomarkers will also be assessed. Discussion: This protocol describes the methodology of study in order to identify neoadjuvant therapy of BL-B01D1 and aumolertinib for resectable stage II–IIIB NSCLC with EGFR mutation. Trial Registration: [Clinicaltrials.gov](Clinicaltrials.gov) identifier: NCT06951464 . Registered on April 23, 2025. Protocol version: version 2.0, May 06, 2025. Keywords: Epidermal growth factor receptor (EGFR); neoadjuvant; non-small-cell lung cancer (NSCLC); BL B01D1; aumolertinib Submitted Jul 18, 2025. Accepted for publication Nov 12, 2025. Published online Dec 17, 2025. doi: 10.21037/tlcr-2025-829 View this article at: [https://dx.doi.org/10.21037/tlcr-2025-829](https://dx.doi.org/10.21037/tlcr-2025-829) © AME Publishing Company.

FAQs

What is the primary objective of this phase II study?

To evaluate the effectiveness and safety of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II–IIIB NSCLC patients with EGFR mutation.

What treatment schedule will participants follow?

Patients will receive BL-B01D1 plus aumolertinib before surgery, then receive aumolertinib as adjuvant treatment after surgery.

What are the primary and secondary endpoints?

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.

Sep 29, 2026

Uploaded by Oliver