Abstract CT301: SHR-A1811 ± adebrelimab as first-line (1L) treatment for advanced HER2-mutant NSCLC: A randomized phase 2 cohort from a phase 1b/2 study

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Authors: Shun Lu, Zhengbo Song, Ziming Li, Haiyong Wang, Yan Yu, Qitao Yu, Shaozhang Zhou, Zhiyong He, Yuxing Wang, Yiping Zhang, Songyan Han, Rui Meng
+20 more Guoqun Zhang, L G Sun, X Chen, Yong Mao, Y Li, Yi Luo, Kangsheng Gu, Xuhong Min, Bo Jin, Runxiang Yang, Y W Zhao, Liqiang Zhong, Yi-Xiang Wang, Zhiguo Zhou, Chengzhi Zhou, Kaijun Zhang, Xiaotong Li, Xinjing Ma, Liju Zong, Y Li
Cited by: 1

Abstract

Abstract Background: Trastuzumab rezetecan (SHR-A1811) is a novel HER2-directed ADC approved for pretreated HER2-mutant NSCLC (Lancet Oncol, 2025). ADCs may enhance antitumor immunity and synergize with immunotherapy. We conducted an open-label, phase 1/2 (dose-escalation/efficacy-exploration) study (NCT05482568) to evaluate SHR-A1811 in combination therapy for HER2-altered NSCLC and here report data from phase 2 Cohort D of 1L SHR-A1811 ± adebrelimab (anti-PD-L1 mAb) for HER2-mutant NSCLC. Methods: Patients (pts) were randomized (1:1) to receive SHR-A1811 (4.8 mg/kg, iv, Q3W) + adebrelimab (1200 mg, iv, Q3W) or SHR-A1811 (4.8 mg/kg, iv, Q3W) alone, stratified by PD-L1 expression (TPS,

Fields of Study & Subjects

HER2/EGFR in Cancer Research Advanced Breast Cancer Therapies Cancer Immunotherapy and Biomarkers

Publication details

Journal / source
Cancer Research
Publisher
American Association for Cancer Research (AACR)
Volume
86
Issue
8_Supplement
Pages
CT301–CT301
Publication date
17 April 2026
Language
EN