Zongertinib (BI 1810631) is currently being evaluated in the Beamion LUNG-2 trial, a Phase III, randomized, open-label study designed to assess its efficacy and safety as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain mutations.

Zongertinib（BI 1810631）目前正在Beamion LUNG-2试验中进行评估，该试验是一项III期随机开放标签研究，旨在评估其作为局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者的一线治疗的疗效和安全性，其中包含HER2酪氨酸激酶结构域突变。

Study Design: Participants: Approximately 270 patients with histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC, possessing HER2 mutations in the tyrosine kinase domain. Randomization: Participants are randomized in a 1:1 ratio to receive either zongertinib or the standard of care.

研究设计：参与者：大约270名经组织学或细胞学证实的晚期或转移性非鳞状NSCLC患者，在酪氨酸激酶结构域中具有HER2突变。随机化：参与者以1:1的比例随机接受zongertinib或标准护理。

Treatment Arms: Experimental Arm: Oral zongertinib at a dose of 120 mg once daily in 21-day cycles. Control Arm: Intravenous pemetrexed (500 mg/m²) combined with either cisplatin (75 mg/m²) or carboplatin (AUC 5), plus pembrolizumab (200 mg), administered on day 1 every three weeks for four cycles. This is followed by maintenance therapy with pemetrexed and pembrolizumab every three weeks for up to 35 cycles.

。对照组：静脉注射培美曲塞（500 mg/m²）联合顺铂（75 mg/m²）或卡铂（AUC 5）加pembrolizumab（200 mg），每三周在第1天给药四个周期。随后每三周用培美曲塞和pembrolizumab维持治疗35个周期。

Endpoints: Primary Endpoint: Progression-free survival, assessed using RECIST 1.1 criteria. Secondary Endpoints: Overall response rate, overall survival, patient-reported outcomes (changes from baseline to week 25), and adverse events graded according to CTCAE 5.0. The trial aims to determine whether zongertinib offers superior efficacy compared to the current standard of care in this patient population.

终点：主要终点：使用RECIST 1.1标准评估的无进展生存期。次要终点：总有效率，总生存期，患者报告的结果（从基线到第25周的变化）以及根据CTCAE 5.0分级的不良事件。该试验旨在确定与该患者人群的当前护理标准相比，宗格替尼是否具有更好的疗效。

For more detailed information, you can refer to the study's registration on ClinicalTrials.gov under the identifier NCT06151574..

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Condition:

条件：

NSCLC/HER 2

非小细胞肺癌/HER 2

Type:

类型：

drug

药物