ArticleAdvances in therapy2026
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.
Article in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06809764 (Clinical Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Patients With HER2 Mutant Metastatic Non-small Cell Lung Cancer), which is not on this map. Not yet cited in PubMed.
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Clinical Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Patients With HER2 Mutant Metastatic Non-small Cell Lung Cancer: a Prospective, Observational Study (RERUN)
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27 authors.
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Abstract
introductionTrastuzumab 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.
methodsRERUN 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 registrationStudy registration number NCT06809764.
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