Advances in therapy · 2026
Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Patients with HER2-Mutant Metastatic Non-Small Cell Lung Cancer (RERUN): Study Protocol for a Real-World, Multicenter, Prospective, Observational Study.
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Duan Jianchun, Zhuo Minglei, Su Chunxia, Liu Yibing, Wang Lifeng, Yang Nong, Cao Baoshan, Hu Mingming, Jin Shi, Li Hui, Li Xiaoyan, Pan Yueyin, Hu Jie, Lu Degan, Tang Chuanhao, Yang Bin, Huang Yunjian, Jiang Guanming, Li Wen, Ni Sujie, Sheng Wang, Tang Kejing, Wang Jing, Wang Qiming, Wang Zhijie, Si Si, Wang Jie
Аннотация
INTRODUCTION: Trastuzumab deruxtecan (T-DXd) is a human epidermal growth factor receptor 2 (HER2)-targeting antibody-drug conjugate that has demonstrated encouraging efficacy and a manageable safety profile in the second-line or later setting for non-small cell lung cancer (NSCLC) harboring HER2 mutations. While T-DXd was approved for treating patients with locally advanced or metastatic HER2-mutant NSCLC in China, real-world data on its use in Chinese clinical practice are lacking. This study will collect real-world data on T-DXd to evaluate its effectiveness and safety in Chinese patients with HER2-mutant metastatic NSCLC, thereby providing additional evidence to the oncology community in China.
METHODS: RERUN is a prospective, multicenter, observational cohort study conducted at approximately 30 sites in China. Approximately 150 adult patients (≥ 18 years) with pathologically documented unresectable and/or metastatic non-squamous NSCLC harboring any known activating HER2 mutation are currently being enrolled. The follow-up period will last approximately 6 months after the last patient is enrolled, when sufficient progression-free survival (PFS) maturity (approximately 60% of patients with events) is expected to be reached. All data will be prospectively collected and analyzed descriptively.
PLANNED OUTCOMES: The primary outcome is real-world PFS assessed by investigators in patients receiving T-DXd as second-line or later therapy. Secondary outcomes include the time to treatment discontinuation or death, best overall response rate, overall survival, and safety and tolerability. This study will support treatment decision-making in routine oncology practice and improve outcomes for Chinese patients with HER2-mutant NSCLC across diverse healthcare settings.
TRIAL REGISTRATION: Study registration number NCT06809764.
METHODS: RERUN is a prospective, multicenter, observational cohort study conducted at approximately 30 sites in China. Approximately 150 adult patients (≥ 18 years) with pathologically documented unresectable and/or metastatic non-squamous NSCLC harboring any known activating HER2 mutation are currently being enrolled. The follow-up period will last approximately 6 months after the last patient is enrolled, when sufficient progression-free survival (PFS) maturity (approximately 60% of patients with events) is expected to be reached. All data will be prospectively collected and analyzed descriptively.
PLANNED OUTCOMES: The primary outcome is real-world PFS assessed by investigators in patients receiving T-DXd as second-line or later therapy. Secondary outcomes include the time to treatment discontinuation or death, best overall response rate, overall survival, and safety and tolerability. This study will support treatment decision-making in routine oncology practice and improve outcomes for Chinese patients with HER2-mutant NSCLC across diverse healthcare settings.
TRIAL REGISTRATION: Study registration number NCT06809764.