Beamion 44: A Randomized, Open-label, Multi-center Phase IIa Platform Trial to Evaluate the Safety and Tolerability of Zongertinib Plus Platinum-based Doublet Chemotherapy With or Without Pembrolizumab (and Potential Other Combinations) in Treatment-naïve Patients With Locally Advanced/Metastatic Non-squamous NSCLC With Activating HER2 Mutations

This study is open to adults with a type of lung cancer called HER2-mutant non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread. People who have a tumor with a HER2 mutation and have not received previous treatment for their lung cancer can participate in the study. The purpose of this study is to find out how well a medicine called zongertinib is tolerated in people with this type of lung cancer, when combined with chemotherapy, with or without pembrolizumab. Zongertinib works by targeting and blocking HER2, a protein involved in cancer cell growth.
Participants are put into two groups randomly, which means by chance. One group gets zongertinib tablets combined with platinum-based chemotherapy. The other group gets the same treatment plus an additional medicine called pembrolizumab. Chemotherapy and pembrolizumab are given as an infusion into a vein. Participants take zongertinib by mouth once a day, while chemotherapy is given every 3 weeks for up to 3 months, followed by maintenance treatment for up to 2 years.
Pembrolizumab is given every 3 weeks for up to 2 years.
This study does not have a fixed duration. Participants can receive some of the study treatments for up to about 2 years and may continue to take zongertinib as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. Doctors regularly check the size of the tumor and whether it has spread. They also monitor participants' health and take note of any unwanted effects.

开始日期2026-05-08

申办/合作机构

Boehringer Ingelheim GmbH

NCT07195695

/ Recruiting临床3期

Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations

This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment. Zongertinib is being developed to target the faulty HER2 protein, which can cause cancer cells to grow.
In this study, participants are assigned by chance to one of two treatment groups, with an equal chance of being in either group. One group takes the study medicine, zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This standard treatment may be an immunotherapy medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular check-ups without active study medicine (observation).
Participants can be in this study for up to about 11 years. During this time, they visit the study site regularly for check-ups and study-related tests. The frequency of these visits varies depending on their treatment and how long they have been in the study. In addition to visits at the study site, participants in some treatment groups will also have phone calls with the study team every 3 weeks to check on their health between their scheduled visits.
Doctors check for any signs of cancer coming back using imaging scans (like CT or MRI scans); these scans are generally done every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly. Participants also fill in questionnaires about their overall wellbeing, health and symptoms. Throughout the study, doctors also check participants' health and note any unwanted effects.

开始日期2026-01-16

申办/合作机构

Boehringer Ingelheim GmbH

100 项与宗艾替尼相关的临床结果

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100 项与宗艾替尼相关的转化医学

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100 项与宗艾替尼相关的专利（医药）

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项与宗艾替尼相关的文献（医药）

2026-03-16·Future Oncology

Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2 -mutant solid tumors

Article

作者: Lunger, Lukas ; Bedard, Philippe L. ; Klotz, Daniel M. ; Ko, Ryo ; Park, John J. ; Schram, Alison M. ; Hussain, Jo ; Erzen, Damijan ; Guo, Ye ; Ponz-Sarvise, Mariano ; Kim, Hyung-Don ; Dumbrava, Ecaterina ; Kitano, Shigehisa ; Prenen, Hans ; Maier, Daniela ; Park, Joon O. ; Clay, Timothy D. ; Maruki, Yuta ; Italiano, Antoine ; Planchard, David ; Hernando-Calvo, Alberto ; van Marcke, Cedric ; Li, Jin

Human epidermal growth factor receptor 2 (HER2, encoded by ERBB2) alterations are known oncogenic drivers in many solid tumors. Zongertinib is a novel, oral, irreversible, HER2-selective tyrosine kinase inhibitor that spares wild-type epidermal growth factor receptor, thereby limiting associated toxicities. In a Phase Ia/Ib trial (NCT04886804), zongertinib demonstrated encouraging activity with a manageable safety profile in HER2-altered tumors (HER2 overexpression, amplification, or mutations).The Phase II, open-label, Beamion PANTUMOR-1 basket trial (NCT06581432) is evaluating the efficacy and safety of zongertinib monotherapy in previously treated patients with HER2-positive (HER2-overexpressed/amplified) or HER2-mutant solid tumors. Patients with HER2-positive tumors will be enrolled to one of eight cohorts: urothelial, biliary tract, uterine, cervical, non-squamous lung, salivary gland, colorectal or tumor agnostic. Patients with HER2-mutant tumors will be enrolled to one of five cohorts: urothelial, breast, gastroesophageal, biliary tract or tumor agnostic. Patients will receive zongertinib 120 mg orally once daily until disease progression (RECIST v1.1), unacceptable toxicity, death, or withdrawal of patient consent, whichever occurs first. The primary endpoint is objective response (central independent review, RECIST v1.1). Secondary endpoints include duration of response, progression-free survival, disease control, occurrence of treatment-emergent adverse events, and health-related quality of life. Recruitment is ongoing in 13 countries globally.Clinical trial registration http://www.clinicaltrials.gov identifier is NCT06581432.

2026-03-01·JTO clinical and research reports

Acquired ERBB2 Amplification and Overexpression as On-Target Resistance Mechanisms to Zongertinib With Subsequent Response to Trastuzumab-Deruxtecan: A Case Report

Article

作者: Yousaf, Nadia ; John, Alexius ; Popat, Sanjay ; Robertus, JanLukas ; MacMahon, Suzanne ; Vick, Joanna ; Amin, Nawa ; Sarker, Sarah ; Tokaca, Nadza ; Kalofonou, Foteini ; McMahon, David John

A number of drugs are in development for the treatment of ERBB2(HER2)-mutated NSCLC, including antibody-drug conjugates such as trastuzumab-deruxtecan and tyrosine kinase inhibitors such as zongertinib and sevabertinib. Herein, we report a case of relapsed advanced ERBB2-mutant NSCLC with acquired resistance to zongertinib potentially mediated through ERBB2 amplification and HER2 3+ immunohistochemistry overexpression with subsequent durable response to fifth-line trastuzumab-deruxtecan. We propose this as a mechanism for zongertinib resistance, one that may underpin a biological rationale for future ERBB2 tyrosine kinase inhibitor-antibody-drug conjugate combination therapy.

2026-03-01·DRUGS

Zongertinib: First Approval

Review

作者: Lee, Arnold

Zongertinib (HERNEXEOS^®) is a small molecule, irreversible, HER2-specific tyrosine kinase inhibitor being developed by Boehringer Ingelheim for the treatment of advanced solid tumours with HER2 aberrations. Zongertinib selectively inhibits HER2-expressing cells, including those with HER2 mutations, while sparing cells expressing wild-type EGFR. It received its first approval under accelerated approval in August 2025 in the USA following positive results from the Beamion LUNG-1 phase Ia/Ib trial in patients with previously treated HER2-mutant non-small cell lung cancer (NSCLC). This article summarizes the milestones in the development of zongertinib leading to this first approval for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

669

项与宗艾替尼相关的新闻（医药）

2026-04-17

·医学新视点

NEJM：无需化疗！口服新药或为HER2突变肺癌带来一线治疗新方案

人表皮生长因子受体2（HER2）变异是非小细胞肺癌（NSCLC）中较为重要的罕见驱动基因之一，主要包括基因突变、扩增和蛋白过表达3种形式。HER2变异NSCLC在中国NSCLC患者中约占2.8%~15.4%。HER2突变特别是外显子20插入突变，与较强的肿瘤侵袭性、更差的预后及对免疫治疗的低反应性密切相关，具有“冷肿瘤”特征。目前，对于经治HER2突变的治疗临床取得了一定进展，但初治HER2突变NSCLC标准治疗仍以化疗联合或不联合免疫治疗为主，尚缺少一线靶向治疗策略。宗艾替尼（zongertinibs）是一种口服、不可逆HER2酪氨酸激酶抑制剂。由于该药物不与野生型EGFR结合，因而其相关毒性较低。近日，Beamion LUNG-1研究部分结果发表于《新英格兰医学杂志》（NEJM），表明未经治疗的HER2突变晚期或转移性NSCLC患者，接受宗艾替尼治疗后，经确认的客观缓解率（ORR）为76%，中位缓解持续时间（DoR）达到15.2个月，中位无进展生存期（PFS）为14.4个月。值得一提的是，活动性脑转移患者接受治疗后，颅内ORR达到47%。截图来源：NEJM Beamion LUNG-1研究是1a–1b、多队列研究，纳入年龄≥18岁、HER2突变晚期或转移性NSCLC患者。本次公布的队列2（74例）为既往未接受过治疗的非鳞状NSCLC患者，队列4（30例）为探索性队列，纳入既往未接受或接受治疗、存在活动性脑转移NSCLC患者。队列2患者每日口服一次、120 mg的宗艾替尼。截至2025年8月21日的数据分析显示，队列2的74例患者经确认的ORR为76%，中位DoR为15.2个月，中位PFS为14.4个月。值得关注的是，在队列4的30例存在活动性脑转移患者中，经确认的颅内ORR为47%。特别是在那些未接受过脑部放疗的患者（23例），其缓解率达到了57%。药物的安全性可控。常见的治疗相关不良事件是腹泻（55%），但绝大多数（52%）为1~2级，仅3%为3级。总之，宗艾替尼作为初治HER2突变晚期或转移性NSCLC的一线治疗措施，显示出持久的抗肿瘤活动，且安全性可控，有望成为这类患者的治疗新选择。文章指出，当前Beamion LUNG-2研究正在进行中，旨在了解宗艾替尼与标准治疗作为一线治疗的疗效。点击文末“阅读原文/Read more”，即可访问期刊官网阅读完整论文。推荐阅读肺癌免疫治疗后能停药吗？JAMA子刊：多数患者仍可长期生存《柳叶刀》子刊：KRAS突变肺癌有望迎来“无化疗、无免疫”的一线治疗联合新方案抗癌新药突破！B7-H3靶向ADC药物，有望为肺癌、食管癌、前列腺癌等多种实体瘤带来治疗新选择《自然-医学》吴一龙团队等研究：下一代CTLA-4抗体展潜力，肺癌“双耐药”患者有望迎来新选择上海市胸科医院韩宝惠、天肿李凯等团队研究：肺癌一线治疗新希望，疾病进展或死亡风险降低题图来源：123RF 参考资料 [1] John V. Heymach, Noboru Yamamoto, Nicolas Girard, et al. First-Line Zongertinib in Advanced HER2-Mutant Non–Small-Cell Lung Cancer. NEJM. Published April 15, 2026. DOI: 10.1056/NEJMoa2516969 [2] HER-2变异晚期非小细胞肺癌诊疗专家共识制定专家组,中国抗癌协会整合肺癌委员会,中国抗癌协会非小细胞肺癌专业委员会. HER-2变异晚期非小细胞肺癌诊疗专家共识（2025版）[J]. 中华肿瘤杂志,2025,47(09)：830-839. DOI:10.3760/cma.j.cn112152-20250414-00163 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com 分享，点赞，在看，传递医学新知

临床结果免疫疗法抗体药物偶联物CSCO会议

2026-04-17

·美通社

宗艾替尼治疗HER2突变晚期非小细胞肺癌初治患者的Beamion LUNG‑1研究结果发表于《新英格兰医学杂志》

德国殷格翰和美国康涅狄格州里奇菲尔德 2026年4月17日 /美通社/ -- 勃林格殷格翰宣布，《新英格兰医学杂志》（NEJM）发表了圣赫途®（宗艾替尼片）在具有HER2酪氨酸激酶结构域（TKD）激活突变的晚期非小细胞肺癌（NSCLC）初治患者中进行的1b期Beamion LUNG-1临床试验结果。题为《宗艾替尼用于一线HER2突变晚期非小细胞肺癌》的原文数据显示，宗艾替尼在该患者群体（N=74）中具有持久疗效。截至2025年8月21日：经确认的客观缓解率（ORR）达76%，其中11%的患者获得完全缓解，65%的患者达到部分缓解。中位缓解持续时间（mDoR）为15.2个月，中位无进展生存期（mPFS）为14.4个月。治疗相关不良事件（AE）以低级别为主。因不良事件导致药物剂量减少的有12名患者（16%），导致停药的有7名患者（9%）。此外，该文章还报告了30名伴有活动性脑转移的HER2突变晚期非小细胞肺癌患者的数据，其中47%的患者获得以神经肿瘤-脑转移缓解评估（RANO-BM）标准确认的颅内客观缓解（iORR）。这些数据进一步丰富了2025年10月欧洲肿瘤内科学会（ESMO）年会上公布的结果，并于2026年3月25至28日在丹麦哥本哈根举行的欧洲肺癌大会（ELCC 2026）上进行了报告。 "这些数据显示，宗艾替尼作为一线疗法在HER2突变晚期非小细胞肺癌初治患者中展现出持久的疗效，而目前这一领域仍然缺乏具有持久缓解的有效治疗选择。"Beamion LUNG‑1研究协调研究者、美国德克萨斯大学MD Anderson癌症中心胸部及头颈肿瘤内科主任John Heymach博士表示，"现在这些研究结果已发表在《新英格兰医学杂志》上，有助于医疗专业人士在HER2靶向治疗方案的选择上做出明智决策。" 宗艾替尼最近获得美国食品药品监督管理局（FDA）批准，用于治疗经FDA批准的检测方法确认携带HER2（ERBB2）酪氨酸激酶结构域（TKD）激活突变的不可切除或转移性非鳞状NSCLC成人患者。该适应症基于客观缓解率和持续缓解时间获得加速批准。其常规批准取决于确证试验的验证。勃林格殷格翰已于2025年10月向中国食品药品监督管理局（NMPA）递交宗艾替尼用于一线HER2突变晚期非小细胞肺癌治疗的新适应症申请。该申请已被纳入优先审评审批程序，目前正在审评中。此次FDA 加速批准前，该药物在中美均已获得突破性疗法认定，并获得 FDA局长国家优先审评券，以表彰该药物在满足罕见且侵袭性强的肺癌患者关键治疗需求方面的潜力。此前，该药物于2025年8月获得美国 FDA加速批准和中国NMPA附条件批准用于经治患者。研究意义 HER2激活突变的非小细胞肺癌是一种高度异质性且侵袭性强的疾病，过去一线治疗少有临床获益显著的靶向治疗方案。 HER2突变存在于约2-4%的非小细胞肺癌患者中，并与不良预后相关。 [1] 部分患者对当前标准疗法（化疗或化疗联合免疫治疗）的反应不佳，临床需求尚未得到充分满足。关于圣赫途 ® （宗艾替尼片）圣赫途®（宗艾替尼片）是一种不可逆酪氨酸激酶抑制剂（TKI），可选择性抑制 HER2（ERBB2），同时保留野生型EGFR，从而有助于降低相关毒性反应。圣赫途®已在多个国家获批：圣赫途®已获得美国食品药品监督管理局（FDA）批准，成为首个且唯一口服、用于HER2（ERBB2）突变晚期一线非小细胞肺癌成人患者的靶向治疗。圣赫途® 已获得中国国家药品监督管理局（NMPA）附条件批准，适用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。中国国家药品监督管理局药品审评中心（CDE）也已授予宗艾替尼片用于一线治疗的突破性疗法认定。作为全球首个针对HER2突变型非小细胞肺癌（NSCLC）的口服靶向治疗药物，宗艾替尼片也已获得日本监管机构的生产与上市许可。该获批标志着宗艾替尼片成为日本首个用于治疗不可切除、晚期或复发性HER2突变非小细胞肺癌经治患者的口服分子靶向疗法。目前，宗艾替尼片在上述以外市场尚未获得批准，该药物针对早期及晚期HER2突变实体瘤患者的临床研究仍在持续推进。关于非小细胞肺癌（ NSCLC ）肺癌是全球致死率最高的恶性肿瘤类型之一 [1] ，预计到2040年，全球肺癌发病人数将超过300万例 [5] 。非小细胞肺癌（NSCLC）是最常见的肺癌类型 [1] 。由于该疾病往往在晚期才被确诊 [2] ，确诊后五年生存率不足30% [2,3] 。晚期非小细胞肺癌患者在日常生活中常面临显著的身体、心理及情绪方面的负面影响 [5,6,7] 。目前，晚期NSCLC患者在治疗选择方面仍存在较高的未满足医疗需求。约有多达4%的肺癌由HER2（ERBB2）突变（基因异常）所驱动 [1] 。HER2基因突变可导致蛋白过度表达和过度激活，进而引发细胞异常增殖、抑制细胞凋亡，并促进肿瘤的生长和扩散 [8] 。关于勃林格殷格翰在肿瘤学领域勃林格殷格翰致力于推动具有深远意义的科学进步，为癌症患者生活带来变革，最终实现治愈各类癌症。公司世世代代推动科学创新的承诺，在稳健的癌细胞靶向与免疫肿瘤学在研疗法产品线，以及巧妙的联合疗法策略中得到生动体现。在肿瘤学领域，勃林格殷格翰矢志不渝地构建广泛合作研究网络，积极寻求多元化的创新思路，这对于攻克极具挑战且影响巨大的癌症研究领域至关重要。简而言之，对于勃林格殷格翰，癌症治疗因人而异，攻克癌症关乎当前和未来的世世代代。更多详情，请访问： www.boehringer-ingelheim.com 。关于勃林格殷格翰勃林格殷格翰是全球领先的生物制药企业，布局人用药品、动物保健两大业务领域。公司研发投入位居行业前列，致力于研究突破性疗法，解决巨大未满足的医疗需求，从而帮助改善或延长生命。自1885年成立以来，勃林格殷格翰一直是独立的家族企业，始终着眼长远发展，将可持续发展理念贯穿全价值链。公司在全球有近5.43万名员工，服务逾130个市场，致力于打造一个更健康、更可持续的未来。更多详情，请访问： www.boehringer-ingelheim.com 。关于勃林格殷格翰与中国生物制药的战略合作勃林格殷格翰与中国生物制药建立战略合作伙伴关系，致力于为中国大陆市场带来创新的肿瘤疗法。此次合作将凭借双方的互补优势，为中国的癌症患者提供更多更好的治疗方案。双方将合作勃林格殷格翰多个处于临床开发晚期阶段的创新肿瘤产品。宗艾替尼是勃林格殷格翰和中国生物制药在中国大陆的战略合作产品之一。 References: [1] Zeng J, Ma W, Young RB, Li T. Targeting HER2 genomic alterations in non-small cell lung cancer. J Natl Cancer Cent. 2021 May 3;1(2):58-73. [2] National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). 5-Year Survival Rates. https://www.seer.cancer.gov/csr/1975_2016/results_merged/topic_survival.pdf (Accessed: February 2026). [3] Casal-Mouriño, A. et al. Epidemiology of stage III lung cancer: frequency, diagnostic characteristics, and survival. Transl Lung Cancer Res. 2021;10(1):506-518. [4] International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: https://gco.iarc.fr/tomorrow/en (Accessed: February 2026). [5] Valentine, T. R. et al. Illness Perceptions and Psychological and Physical Symptoms in Newly Diagnosed Lung Cancer. Health Psychol. 2022 Jun; 41(6): 379–388. [6] Andersen, B. L. et al. Newly diagnosed patients with advanced non-small cell lung cancer: A clinical description of those with moderate to severe depressive symptoms. Lung Cancer. 2020 Jul;145:195-204. [7] Presley, C. J. et al. Functional Disability Among Older Versus Younger Adults With Advanced Non–Small-Cell Lung Cancer. JCO Oncol Pract. 2021 May 3;17(6):e848–e858. [8] Galogre M, et al. A review of HER2 overexpression and somatic mutations in cancers, Critical Reviews in Oncology/Hematology, Volume 186, 2023, 103997.

优先审批突破性疗法加速审批临床结果申请上市

2026-04-17

·BioSpace

/C O R R E C T I O N -- Boehringer Ingelheim/

In the news release, Beamion LUNG-1 study results for zongertinib in treatment-naïve patients with HER2-mutant advanced NSCLC published in The New England Journal of Medicine, issued 16-Apr-2026 by Boehringer Ingelheim over PR Newswire, there has been an update to the headline. The complete, corrected release follows: Beamion LUNG-1 study results for zongertinib in treatment-naïve patients with HER2-mutant advanced NSCLC published in The New England Journal of Medicine RIDGEFIELD, Conn. and INGELHEIM, Germany , April 16, 2026 /PRNewswire/ -- Boehringer Ingelheim today announced that The New England Journal of Medicine (NEJM) published results from the Phase 1b Beamion LUNG-1 trial of HERNEXEOS ® (zongertinib tablets) in treatment-naïve patients with advanced non-small cell lung cancer (NSCLC) who have HER2 activating mutations in the tyrosine kinase domain (TKD). The data in the manuscript, titled "First-Line Zongertinib in Advanced HER2- Mutant Non-Small-Cell Lung Cancer," demonstrated durable efficacy in this patient population (N=74). As of August 21, 2025: The confirmed objective response rate (ORR) was 76%, with 11% of patients achieving a complete response and 65% of patients achieving a partial response. The median duration of response (mDoR) was 15.2 months, and the median progression free survival (mPFS) was 14.4 months. Treatment-related adverse events (AEs) were predominantly low-grade. AEs led to dose reductions in 12 patients (16%) and dose discontinuations in 7 patients (9%). Additionally, the NEJM manuscript reported findings from 30 patients with HER2 -mutant advanced NSCLC with active brain metastases, of which, 47% experienced a confirmed intracranial objective response (iORR) by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM). The data builds on results presented at the ESMO Annual Meeting in October 2025 and was presented at the European Lung Cancer Congress (ELCC 2026) that took place in Copenhagen, Denmark, March 25–28, 2026. "This data shows zongertinib demonstrated durable efficacy as first-line therapy in treatment-naïve patients with HER2-mutant advanced non-small cell lung cancer, a setting where there are currently limited options with durable responses," said coordinating investigator for the Beamion LUNG-1 trial, Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. "These findings, now published in The New England Journal of Medicine, may help healthcare providers make informed decisions on HER2 targeted treatment choices." HERNEXEOS was recently granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 ( ERRB2 ) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication is contingent upon verification in a confirmatory trial. Accelerated approval follows Breakthrough Therapy Designation and selection for the FDA Commissioner’s National Priority Voucher pilot program , in recognition of the medicine's ability to address critical unmet need for this rare and aggressive cancer. This builds upon the FDA accelerated approval for use in previously treated patients in August 2025. About HERNEXEOS ® (zongertinib tablets) HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that inhibits HER2 ( ERBB2 ). 1,2 HERNEXEOS has been approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with HER2 ( ERBB2) -mutant advanced non-small cell lung cancer. Comprehensive biomarker testing using next generation sequencing determines a patient's eligibility for treatment with HERNEXEOS by identifying HER2 ( ERBB2 )-mutant advanced NSCLC. 1,3 The orally administered treatment is not approved in other markets and is being evaluated in ongoing trials, across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as a first-line treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations ( NCT06151574 ). Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 ( ERBB2 )-mutations ( NCT07195695 ) . About HER2 ( ERBB2 )-mutant non-small cell lung cancer (NSCLC) Lung cancer claims more lives than any other cancer type 3 and the incidence is set to increase to over 3 million cases worldwide by 2040. 4 NSCLC is the most common type of lung cancer. 3 The condition is often diagnosed at a late stage, and fewer than 3 in 10 patients are alive five years after diagnosis. 5,6 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives. 7,8,9 There remains a high unmet need for additional treatment options for people living with advanced NSCLC. Up to 4% of lung cancers are driven by HER2 mutations (or gene alterations). 3 Mutations in HER2 can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread. 10 About Boehringer Ingelheim in oncology We have a clear aspiration – to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. Boehringer Ingelheim's generational commitment to driving scientific innovation is reflected by the company's robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as the smart combination of these approaches. Boehringer's ambition in oncology is to take a diligent and broad approach, creating a collaborative research network to tap into a diversity of minds, which is vital in addressing some of the most challenging, but potentially most impactful, areas of cancer research. Simply put, for Boehringer Ingelheim, cancer care is personal, today and for generations. Read more at Boehringer-Ingelheim.com/US . About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at Boehringer-Ingelheim.com/US . What is HERNEXEOS (zongertinib tablets)? HERNEXEOS is a prescription medicine used to treat adults with a type of lung cancer called non–squamous non–small cell lung cancer (NSCLC) that: cannot be removed by surgery or that has spread to other parts of your body (metastatic), and has a certain mutation in the human epidermal growth factor receptor 2 ( HER2 ) gene Your healthcare provider will perform a test to make sure HERNEXEOS is right for you. It is not known if HERNEXEOS is safe and effective in children. IMPORTANT SAFETY INFORMATION Before taking HERNEXEOS, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have heart problems have lung or breathing problems other than lung cancer are pregnant or plan to become pregnant. HERNEXEOS can harm your unborn baby Females who are able to become pregnant: Your healthcare provider will do a pregnancy test before you start treatment with HERNEXEOS Use an effective form of birth control (contraception) during treatment with HERNEXEOS and for 2 weeks after your last dose Talk to your healthcare provider about birth control methods that might be right for you during this time Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with HERNEXEOS are breastfeeding or plan to breastfeed. It is not known if HERNEXEOS passes into your breastmilk. Do not breastfeed during treatment and for 2 weeks after your last dose of HERNEXEOS Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. HERNEXEOS may affect the way other medicines work, and other medicines may affect how HERNEXEOS works. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. What are the possible side effects of HERNEXEOS? HERNEXEOS may cause serious side effects, including: liver problems. Liver problems are common with HERNEXEOS and can be severe and life-threatening. Your healthcare provider will do blood tests to check your liver function before you start taking HERNEXEOS and during your treatment. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including: yellowing of your skin or the white part of your eyes (jaundice) dark or brown (tea colored) urine pain on the upper right side of your stomach area (abdomen) bleeding or bruising more easily than normal feeling very tired loss of appetite nausea or vomiting heart problems that may affect your heart's ability to pump blood. HERNEXEOS can cause severe heart problems. Your healthcare provider will do tests to check your heart function before you start taking HERNEXEOS and during treatment. Tell your healthcare provider right away if you have any new or worsening symptoms of heart problems, including: feeling like your heart is pounding or racing dizziness tiredness feeling lightheaded shortness of breath loss of consciousness coughing swelling of your legs, ankles, or feet lung problems . HERNEXEOS can cause lung problems that are severe or life-threatening. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever Your healthcare provider may temporarily stop, decrease your dose, or permanently stop treatment with HERNEXEOS if you have serious side effects. The most common side effects of HERNEXEOS include: diarrhea. HERNEXEOS can cause severe diarrhea. Tell your healthcare provider right away if you have new or worsening diarrhea rash liver problems feeling tired nausea muscle and joint pain upper respiratory tract infection The most common severe abnormal blood tests include decreased white blood cell count, increased liver function tests, and decreased potassium levels. HERNEXEOS may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of HERNEXEOS. Call your doctor for medical advice about side effects. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. CL-HER-100001 02.2026 For U.S. Audiences, please see full Prescribing Information and Patient Information . MPR-US-104011 References: HERNEXEOS Prescribing Information. Wilding B, Woelflingseder L, Baum A, et al. Zongertinib (BI 1810631), an Irreversible HER2 TKI, Spares EGFR Signaling and Improves Therapeutic Response in Preclinical Models and Patients with HER2-Driven Cancers. Cancer Discov . 2025;15(1):119-138. doi:10.1158/2159-8290.CD-24-0306 Zeng J, Ma W, Young RB, Li T. Targeting HER2 genomic alterations in non-small cell lung cancer. J Natl Cancer Cent. 2021 May 3;1(2):58-73. International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: (Accessed: February 2026). National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). 5-Year Survival Rates. (Accessed: February 2026). Casal-Mouriño, A. et al. Epidemiology of stage III lung cancer: frequency, diagnostic characteristics, and survival. Transl Lung Cancer Res. 2021;10(1):506-518 Valentine, T. R. et al. Illness Perceptions and Psychological and Physical Symptoms in Newly Diagnosed Lung Cancer. Health Psychol. 2022 Jun; 41(6): 379–388. Andersen, B. L. et al. Newly diagnosed patients with advanced non-small cell lung cancer: A clinical description of those with moderate to severe depressive symptoms. Lung Cancer. 2020 Jul;145:195-204. Presley, C. J. et al. Functional Disability Among Older Versus Younger Adults With Advanced Non–Small-Cell Lung Cancer. JCO Oncol Pract. 2021 May 3;17(6):e848–e858. Galogre M, et al. A review of HER2 overexpression and somatic mutations in cancers, Critical Reviews in Oncology/Hematology, Volume 186, 2023, 103997. View original content to download multimedia: SOURCE Boehringer Ingelheim

临床结果临床3期加速审批临床1期突破性疗法

100 项与宗艾替尼相关的药物交易

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适应症	国家/地区	公司	日期
转移性非鳞状非小细胞肺癌	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2026-02-26
HER2阳性非鳞状非小细胞肺癌	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2025-08-08
HER2突变型非小细胞肺癌	美国	Boehringer Ingelheim GmbH	2025-02-26

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌	申请上市	加拿大	Boehringer Ingelheim (Canada) Ltd.	2026-01-01
可切除非小细胞肺癌	临床3期	美国	Boehringer Ingelheim GmbH	2026-01-16
可切除非小细胞肺癌	临床3期	中国	Boehringer Ingelheim GmbH	2026-01-16
可切除非小细胞肺癌	临床3期	日本	Boehringer Ingelheim GmbH	2026-01-16
可切除非小细胞肺癌	临床3期	阿根廷	Boehringer Ingelheim GmbH	2026-01-16
可切除非小细胞肺癌	临床3期	澳大利亚	Boehringer Ingelheim GmbH	2026-01-16
可切除非小细胞肺癌	临床3期	奥地利	Boehringer Ingelheim GmbH	2026-01-16
可切除非小细胞肺癌	临床3期	比利时	Boehringer Ingelheim GmbH	2026-01-16
可切除非小细胞肺癌	临床3期	巴西	Boehringer Ingelheim GmbH	2026-01-16
可切除非小细胞肺癌	临床3期	加拿大	Boehringer Ingelheim GmbH	2026-01-16

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESMO_TAT2026	N/A	HER2突变型非小细胞肺癌 HER2 YVMA \| HER2 non-YVMA	13	Zongertinib	選積積糧壓衊艱繭製鹹(鑰膚衊夢壓餘窪襯餘襯) = 獵繭憲蓋膚衊蓋襯網顧膚範齋廠淵鹽積顧醖膚 (簾選鏇製遞衊壓遞糧積 ) 更多	积极	2026-03-16
				Zongertinib (YVMA mutation)	齋廠遞築壓餘餘構衊襯(淵選憲繭憲鹹鬱廠鏇遞) = 鏇膚鬱製艱醖鑰糧糧簾鹹衊醖範簾窪艱積壓願 (糧遞蓋夢製鬱鏇鑰鬱窪 ) 更多
NCT06504862 (CTgov)	临床1期	-	32	Dabigatran-etexilate (Dabigatran-etexilate (R))	鑰願鬱壓憲鹽夢網選淵(鏇淵鏇夢壓淵獵艱廠餘) = 夢壓獵窪網願窪糧顧糧顧築選鏇艱襯網觸艱齋 (鏇築鑰艱積構積遞壓觸, NA) 更多	-	2026-01-09
				Zongertinib+dabigatran-etexilate (T (Zongertinib and dabigatran-etexilate (T))	鑰願鬱壓憲鹽夢網選淵(鏇淵鏇夢壓淵獵艱廠餘) = 網網鑰壓顧廠鑰築遞網顧築選鏇艱襯網觸艱齋 (鏇築鑰艱積構積遞壓觸, NA) 更多
NCT04886804 (ESMO_ASIA2025) 人工标引	临床1期	HER2突变型非小细胞肺癌 ERBB2 Mutation	39	Zongertinib 120 mg (East Asian patients)	蓋廠繭遞鬱淵簾鏇鏇壓(鏇簾網鏇憲鏇鏇糧鬱鏇) = 淵簾願鏇廠網鏇繭願願壓蓋憲膚醖鹹膚壓繭範 (襯襯鹹壓鏇艱蓋夢繭憲, 61.7 ~ 87.4) 更多	积极	2025-12-05
				Zongertinib 120 mg (Chinese patients)	蓋廠繭遞鬱淵簾鏇鏇壓(鏇簾網鏇憲鏇鏇糧鬱鏇) = 餘遞艱襯積餘顧醖膚構壓蓋憲膚醖鹹膚壓繭範 (襯襯鹹壓鏇艱蓋夢繭憲, 60.8 ~ 94.2) 更多
NCT04886804 (Beamion LUNG-1, ESMO_ASIA2025)	临床1期	HER2突变型非小细胞肺癌二线 HER2-mutant	75	Zongertinib 120 mg (second line [2L])	築繭壓齋選膚鬱壓獵膚(窪糧遞糧廠膚選顧壓鬱) = 鑰窪夢網醖鏇範壓構壓遞鬱網願廠鬱廠選糧構 (淵窪憲餘餘構夢艱糧鹽, 59.7 ~ 84.4) 更多	积极	2025-12-05
				Zongertinib 120 mg (third line [3L])	築繭壓齋選膚鬱壓獵膚(窪糧遞糧廠膚選顧壓鬱) = 膚願選積襯艱艱醖鏇簾遞鬱網願廠鬱廠選糧構 (淵窪憲餘餘構夢艱糧鹽, 46.8 ~ 91.1) 更多
NCT05879991 (Pubmed \| Clin Drug Investig)	临床1期	-	15	Zongertinib	廠憲積簾鹽觸鹹壓淵醖(壓齋糧壓觸鹹構夢窪範) = 襯鬱餘構憲願鏇築憲壓鹹築廠憲簾齋選衊齋鬱 (製鏇繭醖選餘獵衊遞顧 )	积极	2025-12-05
				Zongertinib (Oral tablet and intravenous infusion)	壓鑰艱襯壓鏇淵膚鏇遞(選膚遞選衊網鑰鏇鏇繭) = 顧製範醖範範鑰觸鏇夢餘構範製壓憲鬱積糧餘 (鑰夢構醖鹽繭襯積範鑰 ) 更多
NCT06028464 (CTgov)	临床1期	-	16	Zongertinib (Zongertinib Alone (Reference, R))	膚夢齋願齋窪膚繭顧積(廠窪衊繭鏇範廠繭獵夢) = 壓蓋襯觸鹽鏇鬱齋繭醖餘齋構憲積網鹽築遞遞 (獵鑰糧築鹹鬱廠簾築獵, NA) 更多	-	2025-11-05
				Carbamazepine+Zongertinib (Zongertinib+Carbamazepine (Test, T))	膚夢齋願齋窪膚繭顧積(廠窪衊繭鏇範廠繭獵夢) = 糧餘遞鹽廠窪鏇簾鏇糧餘齋構憲積網鹽築遞遞 (獵鑰糧築鹹鬱廠簾築獵, NA) 更多
NCT05380947 (CTgov)	临床1期	-	13	BI 1810631 (TF1 Fasted (R))	簾夢淵蓋選簾壓餘膚願(構糧壓顧蓋願鬱獵築範) = 範顧構蓋網餘壓積選範壓襯淵夢顧憲壓鹽鬱夢 (願鹹網襯壓選膚網鬱鏇, 52.7) 更多	-	2025-11-04
				BI 1810631 (NF Fasted (T1))	簾夢淵蓋選簾壓餘膚願(構糧壓顧蓋願鬱獵築範) = 衊獵築襯鑰遞夢夢繭憲壓襯淵夢顧憲壓鹽鬱夢 (願鹹網襯壓選膚網鬱鏇, 18.8) 更多
NCT04886804 (Beamion LUNG-1, ESMO2025) 人工标引	临床1期	HER2突变型非小细胞肺癌一线 HER2-mutant	74	Zongertinib 120 mg	糧膚積衊齋鏇蓋築選觸(選獵艱醖網壓鏇夢範壓) = 遞鏇獵築膚廠夢齋鏇齋壓構襯遞鬱構鹹鏇艱願 (顧獵獵壓餘膚獵築襯膚, 66 ~ 85) 更多	积极	2025-10-17
NCT04886804 (Beamion LUNG-1, ESMO2025) 人工标引	临床1期	HER2突变型非小细胞肺癌 ERBB2 Mutation	185	Zongertinib (HER2 aberration-positive solid tumors, Phase Ia)	憲艱築繭鹹膚鏇鹽憲餘(範鹽壓獵簾醖憲衊願鬱) = 範觸築憲築選選蓋廠淵顧願遞範襯範構簾構襯 (膚鹽鏇選鏇鹹夢齋積膚 ) 更多	积极	2025-10-17
				Zongertinib (previously treated HER2-mutant NSCLC, Phase Ib Cohort 1)	憲艱築繭鹹膚鏇鹽憲餘(範鹽壓獵簾醖憲衊願鬱) = 積廠廠繭顧範繭憲築鏇顧願遞範襯範構簾構襯 (膚鹽鏇選鏇鹹夢齋積膚 ) 更多
NCT05833139 (CTgov)	临床1期	-	16	Zongertinib (Zongertinib Alone)	網範艱艱範衊製艱襯淵(齋衊網艱蓋製鹹衊遞衊) = 膚製鹹窪鑰夢遞構觸衊鑰網膚夢簾糧醖願壓觸 (構範憲築夢衊選淵構衊, NA) 更多	-	2025-09-22
				Itraconazole+Zongertinib (Zongertinib + Itraconazole)	網範艱艱範衊製艱襯淵(齋衊網艱蓋製鹹衊遞衊) = 鬱齋夢糧襯餘廠鹽餘餘鑰網膚夢簾糧醖願壓觸 (構範憲築夢衊選淵構衊, NA) 更多