Delving into the Latest Updates on Zongertinib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

佐博替尼, 宗格替尼, BI 1810631

+ [4]

Target

HER2

Action

antagonists

Mechanism

HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists)

Therapeutic Areas

NeoplasmsRespiratory DiseasesDigestive System Disorders+ [3]

Active Indication

HER2 mutant non-small cell lung cancerHER2-positive Non-squamous non-small cell lung cancerNon-small cell lung cancer stage IIIB+ [20]

Inactive Indication-

Originator Organization

Boehringer Ingelheim Pharmaceuticals, Inc.

Active Organization

Boehringer Ingelheim GmbHBoehringer Ingelheim International GmbHC.H. Boehringer Sohn AG & Co. KG

+ [5]

Inactive Organization-

License Organization

Boehringer Ingelheim GmbH

Sino Biopharmaceutical Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (08 Aug 2025),

HER2-positive Non-squamous non-small cell lung cancer

RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (Japan), Commissioner's National Priority Voucher (United States), Breakthrough Therapy (China), Priority Review (United States), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States)

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Structure/Sequence

Molecular FormulaC29H29N9O2

InChIKeyYSGNGFPNTLERCR-UHFFFAOYSA-N

CAS Registry2728667-27-2

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.

Start Date16 Jan 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06692322

/ CompletedPhase 1

Pharmacokinetics, Safety and Tolerability of Zongertinib Following Oral Administration in Male and Female Participants of Non-childbearing Potential With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) Compared With Matched Male and Female Participants of Non-childbearing Potential With Normal Hepatic Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)

This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m^2 can take part. Women can only participate if they cannot get pregnant. This study includes people with mild liver problems, people with moderate liver problems, and people without liver problems as a matching control. The purpose of this study is to find out how mild and moderate liver problems affect how the body handles a medicine called zongertinib.
Participants take zongertinib once as tablets. Participants with liver problems are treated in a step-by-step approach with a few days in between for the doctors to review the data and make sure the participants can tolerate the treatment. Participants may continue their regular treatment for their liver problems during the study.
Participants are in the study for about 5 weeks. During this time, they visit the study site 4 times. This also includes an overnight stay for 6 nights. During study visits, the doctors regularly check participants' health and take note of any unwanted effects. To assess the study endpoints, the study staff regularly takes blood samples.

Start Date15 Jan 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06581432

/ RecruitingPhase 2

Beamion PANTUMOR-1: A Phase II, Multicentre, Multicohort, Open-label Trial to Evaluate the Efficacy and Safety of Oral Zongertinib (BI 1810631) for the Treatment of Selected HER2-mutated or Overexpressed/Amplified Solid Tumours

This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2.
Participants are put into 13 groups based on the type of advanced cancer and the type of HER2 alterations they have. All participants take one dose of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it.
Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.

Start Date11 Oct 2024

Sponsor / Collaborator

C.H. Boehringer Sohn AG & Co. KG

100 Clinical Results associated with Zongertinib

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100 Translational Medicine associated with Zongertinib

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100 Patents (Medical) associated with Zongertinib

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26

Literatures (Medical) associated with Zongertinib

01 Feb 2026·PHARMACOLOGICAL RESEARCH

Properties of FDA-approved small molecule protein kinase inhibitors: A 2026 update

Review

Author: Roskoski, Robert

Because of the dysregulation of protein kinase activity in many neoplastic and inflammatory diseases, protein kinases are among the most significant drug targets in the 21st century. Of the 94 FDA-approved protein kinase inhibitors, ten were approved in 2025. Of these drugs, six target dual specificity protein kinases (MEK1/2), fourteen inhibit protein-serine/threonine kinases, twenty-six block nonreceptor protein-tyrosine kinases, and 48 target receptor protein-tyrosine kinases. Most of these drugs (≈ 80) are prescribed for the management of neoplasms and others are used for the treatment of inflammatory and miscellaneous diseases. Of the 94 FDA-approved agents, about two dozen are used in the treatment of multiple diseases. The following ten drugs received FDA approval in 2025 - avutometinib (inhibiting MEK1/2 in serous ovarian carcinomas), defactinib (blocking FAK in low grade serous ovarian carcinomas), delgocitinib (antagonizing the JAK family in hand eczema), mirdametinib (inhibiting MEK1/2 in type I neurofibromatosis), remibrutinib (blocking BTK in chronic spontaneous urticaria), rilzabrutinib (antagonizing BTK in chronic immune thrombocytopenia), sunvozertinib (blocking mutant exon 21 insertion EGFR NSCLC), taletrectinib (inhibiting mutant ROS1 in NSCLC), vimseltinib (blocking CSF1R in tenosynovial giant cell tumors), and zongertinib (antagonizing mutant HER2 in NSCLC). Ninety of the approved protein kinase blockers are orally bioavailable. This article summarizes the physicochemical properties of all 94 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 45 of the 94 FDA-approved drugs have a least one Lipinski rule of five violation.

01 Jan 2026·Journal of Thoracic Oncology

Loss of payload sensitivity and other mechanisms of resistance to T-DXd in HER2-mutant NSCLC: implications for subsequent responsiveness to HER2 TKIs

Article

Author: Alizadeh, Ash A. ; Kittler, Ralf ; Jun, Soyeong ; Esfahani, Mohammad Shahrokh ; Kumar, Ashwani ; Weipert, Caroline M. ; Kang, Xiaoman ; Shibata, Yuji ; Poteete, Alissa ; Wakelee, Heather ; Wang, Jing ; Mutter, Jurik ; Heymach, John V. ; Huo, Xiaofang ; Ren, Xiaoyang ; Sugio, Takeshi ; Oguchi, Kei ; Wang, Rui ; Nilsson, Monique B. ; Le, Xiuning ; Soltys, Scott ; Diehn, Maximilian ; Liu, Ximeng ; Tran, Hai ; Almanza, Diego ; Minamiguchi, Kazuhisa ; Huang, Qian ; Yu, Xiaoxing ; He, Junqin ; Xi, Yuanxin ; Hong, Lingzhi ; Moran, Cesar

INTRODUCTION:

Effective therapies are needed for NSCLC patients with HER2 mutant tumors that progress on the HER2 antibody drug conjugate trastuzumab deruxtecan (T-DXd), a standard-of-care treatment. A greater understanding of mechanisms mediating acquired T-DXd resistance and whether these tumors could benefit from HER2 tyrosine kinase inhibitors (TKIs) is needed.

METHODS:

Using preclinical models of acquired T-DXd resistance, LentiMutate scanning mutagenesis, and clinical analyses, we investigated mechanisms mediating acquired resistance to T-DXd and assessed the impact of each of these resistance mechanisms on cross-resistance to alternative HER2 targeting approaches.

RESULTS:

We determined that acquired resistance to T-DXd could occur through multiple mechanisms including payload resistance which could be mediated by SFLN11 loss and copy number gains in the efflux pump ABCC1/MRP1. Moreover, T-DXd resistance could be mediated by secondary HER2 extracellular mutations in domain IV, the trastuzumab binding site. Tumor cells with acquired payload resistance or domain IV mutations maintained HER2 signaling and remained sensitive to HER2 TKIs including zongertinib or poziotinib. Likewise, patients with HER2 mutant NSCLC treated with poziotinib demonstrated similar response rates regardless of prior T-DXd.

CONCLUSIONS:

In HER2 mutant NSCLC patients, loss of HER2 is not a universal mechanism of T-DXd resistance. Collectively, these data highlight multiple mechanisms of resistance to T-DXd that do not result in loss of HER2 TKI responsiveness.

15 Dec 2025·CANCER

Oral TKI zongertinib gains accelerated approval for HER2 ‐mutant NSCLC

Author: Lawrence, Leah

67

News (Medical) associated with Zongertinib

15 Jan 2026

·firstwordpharma.com

Lilly, Sanofi reportedly face delays of FDA drug reviews in new voucher programme

A number of drugs being reviewed by the FDA that have been awarded one of the new Commissioner's National Priority Vouchers (CNPVs) are facing delays in the regulatory process, pushing back potential approval, Reuters reported Thursday. Medicines facing hold ups include Boehringer Ingelheim's zongertinib, Disc Medicine's bitopertin, Eli Lilly's orforglipron and Sanofi's Tzield (teplizumab-mzwv).Launched amid much fanfare last June, the CNPV initiative aims to cut the timeline for reviewing drug and biologic marketing applications down to within a month or two, but only for companies that are "aligned with US national priorities," sparking questions over the legality, transparency and safety of CNPVs. Concerns over the programme are said to have been the reason why FDA veteran Richard Pazdur recently stepped down as director of the agency's Center for Drug Evaluation and Research (CDER).According to Reuters — citing internal documents it viewed — Sanofi's bid to expand approval of Tzield to adults and paediatric patients eight years of age and older recently diagnosed with stage 3 type 1 diabetes had an original decision date of November 21 last year. The anti-CD38 antibody had been awarded a CNPV on October 16, with the French drugmaker announcing a few days later that the FDA had accepted the filing for review.The documents seen by Reuters suggest that the agency has delayed its decision on Tzield due to a treatment-related death along with other adverse event reports, including two related to seizure and blood clotting. Earlier this week, Sanofi confirmed that its plans to seek expanded approval of the therapy in Europe to include recently diagnosed stage 3 type 1 diabetes have been placed on hold following discussions with the EMA, although no further details were provided.Meanwhile, Disc Medicine's bid for accelerated approval of bitopertin in erythropoietic protoporphyria, including X-linked protoporphyria — submitted last September — has also reportedly been delayed due to concerns about trial data and the GlyT1 inhibitor's risk for abuse. The Reuters report suggested a decision on the marketing application has been pushed back by two weeks to February 10.Internal documents cited by Reuters indicate the FDA has concerns over whether pain-free time in the sun — a secondary endpoint used in clinical trials of bitopertin — is a statistically robust measure of efficacy. In addition, agency staff responsible for scheduling drugs that have a potential for abuse or addiction are also looking at whether bitopertin poses any abuse risks.Delay for Lilly's oral obesity drug?Reuters also suggested that a decision on Lilly's submission seeking approval of its once-daily oral small molecule GLP-1 receptor agonist orforglipron for weight loss is expected by April 10, having been originally anticipated in late-March. A company spokesperson confirmed that, based on current FDA guidance, a decision could come in the second quarter.The timeliness of orforglipron's approval is important to Lilly, given that rival Novo Nordisk won the race to bring an oral obesity drug to market in the US, following FDA clearance of oral Wegovy (semaglutide) at the end of 2025. See - Vital Signs: Novo's oral Wegovy is priced to move and JPM26: Novo Nordisk, Eli Lilly trade blows on oral obesity aspirations.Reuters added that a decision on Boehringer Ingelheim's zongertinib in first-line HER2-mutated non–small-cell lung cancer (NSCLC) is currently expected in mid-February. The tyrosine kinase inhibitor gained accelerated approval as Hernexeos for unresectable or metastatic, second-line HER2-mutated, non-squamous NSCLC last August (for related analysis, see - Spotlight On: Boehringer looks to get jump on Bayer in first-line HER2-positive lung cancer race). In response to the Reuters report, Andrew Nixon, a spokesperson for the US Department of Health and Human Services, said that while the FDA does not comment on applications that are under review, its divisions are allowed the flexibility to adjust time lines if required.

Drug ApprovalAccelerated Approval

12 Jan 2026

·www.biospace.com

Boehringer Ingelheim announces clinical collaboration with Jazz Pharmaceuticals to advance HER2-targeted therapy in breast cancer

Phase 1b study to evaluate combination of zongertinib and zanidatamab in HER2-positive breast cancer patients Ingelheim, Germany– 12 January, 2026 – Boehringer Ingelheim today announced a strategic clinical collaboration with Jazz Pharmaceuticals (Nasdaq: JAZZ) on the exploration of a novel combination therapy for patients with HER2-positive breast cancer. As part of this collaboration, the partners will initiate a Phase 1b cohort within Boehringer’s ongoing Beamion-BCGC1 trial, evaluating the combination of Boehringer’s zongertinib and Jazz’s zanidatamab in breast cancer. Despite significant progress in HER2-targeted therapies, HER2-positive breast cancer remains an aggressive subtype, accounting for approximately 15–20% of all breast cancers. Advanced or metastatic patients still have poor five-year survival rates, around 50%. This collaboration aims to improve patient outcomes by combining two differentiated HER2-targeted approaches, potentially offering a new therapeutic option for patients. “At Boehringer Ingelheim, we are committed to pushing the boundaries of science to deliver innovative solutions for patients with high unmet need,” said Itziar Canamasas, Global Head of Oncology at Boehringer Ingelheim. “By combining zongertinib’s precision approach with zanidatamab’s unique bispecific antibody mechanism, we aim to unlock new possibilities for patients living with HER2-expressing breast cancer.” Amal Melhem-Bertrandt, VP, Oncology Therapy Area Head and Zanidatamab Global Clinical Lead at Jazz Pharmaceuticals., said, “This research collaboration with Boehringer Ingelheim is centered in our shared vision to transform treatment paradigms in HER2-expressing breast cancer through the investigation of this novel HER2-targeted combination therapy, as well as possible opportunities to advance outcomes in multiple tumor types.” HERNEXEOS® (zongertinib tablets) recently received FDA (accelerated) approval in the U.S., CDE (conditional) approval in China, and PMDA marketing authorization in Japan as the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC). In the Beamion LUNG-1 trial, zongertinib demonstrated an objective response rate (ORR) of 71% specifically in pre-treated patients with HER2-mutant NSCLC, along with durable responses. Zongertinib is also under investigation in ongoing clinical trials for various HER2-driven tumors. ZIIHERA® (zanidatamab), a bispecific HER2-directed antibody, has received accelerated approval from the U.S. FDA for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. Further, it is currently in Phase III trials for GEA, BTC and metastatic breast cancer, and is also being investigated in earlier lines of therapy in other tumor types. The companies anticipate that this study will generate critical insights into the safety and efficacy of dual HER2 blockade and inform the development of a potential future combination therapy. 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 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at . Intended Audiences Notice This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

Phase 3Phase 1Drug ApprovalClinical ResultAccelerated Approval

15 Dec 2025

·endpoints.news

FDA fast tracks J&J's multiple myeloma treatment shortly after Phase 3 data release

Johnson & Johnson’s Tecvayli and Darzalex combination treatment scored another win in second-line multiple myeloma, with the FDA moving with unprecedented speed after the latest data to issue a new voucher that expedites the combo’s review to one to two months. “Vigilant FDA leaders just saw an impressive multiple myeloma trial result” published ahead of last week’s American Society of Hematology conference in Orlando, FL, Commissioner Marty Makary wrote on X on Monday. Agency experts conferred and “contacted the company THE NEXT DAY to issue them a national priority voucher.” Hand-picking a treatment for an accelerated review so quickly after the release of Phase 3 trial results is rare for an agency that typically avoids commenting on data under review. The company said the combo treatment’s supplemental drug application is already included in the FDA’s Real-Time Oncology Review program, where it will see its review expedited too. J&J’s data, first unveiled in mid-October, were the first Phase 3 readout for the combination as well as for Tecvayli, which targets both BCMA on myeloma cells and CD3 on T cells. The overall survival result is particularly surprising, as the combination showed significant improvement compared to currently available regimens at the first interim analysis. The data were published Dec. 9 in the New England Journal of Medicine . The Commissioner’s National Priority Voucher awarded to J&J on Monday is the 16th the FDA has issued so far under the pilot program that looks to shave up to 10 months off of a drug review. The other awarded vouchers address a range of Makary’s priorities, including jumpstarting certain key API production in the US and finding new treatments for difficult-to-treat conditions like pancreatic cancer. Also receiving vouchers were Regeneron’s new gene therapy for an inherited type of deafness in children, Eli Lilly’s oral GLP-1 orforglipron, and Boehringer Ingelheim’s zongertinib for HER-2 lung cancer.

Phase 3Clinical ResultGene TherapyPriority Review

100 Deals associated with Zongertinib

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 mutant non-small cell lung cancer	China	Boehringer Ingelheim International GmbH	26 Aug 2025
HER2-positive Non-squamous non-small cell lung cancer	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	08 Aug 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-small cell lung cancer stage IIIB	Phase 3	United States	Boehringer Ingelheim GmbH	16 Jan 2026
Non-small cell lung cancer stage IIIB	Phase 3	China	Boehringer Ingelheim GmbH	16 Jan 2026
Non-small cell lung cancer stage IIIB	Phase 3	Japan	Boehringer Ingelheim GmbH	16 Jan 2026
Non-small cell lung cancer stage IIIB	Phase 3	Argentina	Boehringer Ingelheim GmbH	16 Jan 2026
Non-small cell lung cancer stage IIIB	Phase 3	Australia	Boehringer Ingelheim GmbH	16 Jan 2026
Non-small cell lung cancer stage IIIB	Phase 3	Austria	Boehringer Ingelheim GmbH	16 Jan 2026
Non-small cell lung cancer stage IIIB	Phase 3	Belgium	Boehringer Ingelheim GmbH	16 Jan 2026
Non-small cell lung cancer stage IIIB	Phase 3	Brazil	Boehringer Ingelheim GmbH	16 Jan 2026
Non-small cell lung cancer stage IIIB	Phase 3	Canada	Boehringer Ingelheim GmbH	16 Jan 2026
Non-small cell lung cancer stage IIIB	Phase 3	Chile	Boehringer Ingelheim GmbH	16 Jan 2026

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06504862 (CTgov)	Phase 1	-	32	Dabigatran-etexilate (Dabigatran-etexilate (R))	ewdkpjcxnf(hulecfdpks) = amsotgcugt owetbizzdr (cbqvsehjgn, NA) View more	-	09 Jan 2026
				Zongertinib+dabigatran-etexilate (T (Zongertinib and dabigatran-etexilate (T))	ewdkpjcxnf(hulecfdpks) = fabbkyxwox owetbizzdr (cbqvsehjgn, NA) View more
NCT04886804 (ESMO_ASIA2025) Manual	Phase 1	HER2 mutant non-small cell lung cancer ERBB2 Mutation	39	Zongertinib 120 mg (East Asian patients)	rxfukdbtrr(amkrdjbatw) = uwbqsduyhn xgjjmqjkzr (txkmmbsggh, 61.7 - 87.4) View more	Positive	05 Dec 2025
				Zongertinib 120 mg (Chinese patients)	rxfukdbtrr(amkrdjbatw) = wuudkygvkb xgjjmqjkzr (txkmmbsggh, 60.8 - 94.2) View more
NCT05879991 (Pubmed \| Clin Drug Investig)	Phase 1	-	15	Zongertinib	vbuzusoafj(xwqlatmrnk) = jgtflgwpht byhfgspixk (ajgxeukmin )	Positive	05 Dec 2025
				Zongertinib (Oral tablet and intravenous infusion)	nbfsakczyj(hggusjwfpw) = pvvptxiouy uwdbbogjzv (pihahwblls ) View more
NCT04886804 (Beamion LUNG-1, ESMO_ASIA2025)	Phase 1	HER2 mutant non-small cell lung cancer Second line HER2-mutant	75	Zongertinib 120 mg (second line [2L])	mzbgdgfwco(hmxvnqijdw) = bvexystthm ffhyebqjup (pxtbjvbfos, 59.7 - 84.4) View more	Positive	05 Dec 2025
				Zongertinib 120 mg (third line [3L])	mzbgdgfwco(hmxvnqijdw) = gyrvtbwbuc ffhyebqjup (pxtbjvbfos, 46.8 - 91.1) View more
NCT06028464 (CTgov)	Phase 1	-	16	Zongertinib (Zongertinib Alone (Reference, R))	ciowffduuy(ozikeysstc) = jmckesdayu srqbmyjoan (jixgueeelx, NA) View more	-	05 Nov 2025
				Carbamazepine+Zongertinib (Zongertinib+Carbamazepine (Test, T))	ciowffduuy(ozikeysstc) = jhocaqbims srqbmyjoan (jixgueeelx, NA) View more
NCT05380947 (CTgov)	Phase 1	-	13	BI 1810631 (TF1 Fasted (R))	mzmkkpuxbn(olaenqhjoy) = kmfihjorkp uahgkegjck (qrjuxtwuam, 52.7) View more	-	04 Nov 2025
				BI 1810631 (NF Fasted (T1))	mzmkkpuxbn(olaenqhjoy) = qcitmnijiz uahgkegjck (qrjuxtwuam, 18.8) View more
NCT04886804 (Beamion LUNG-1, ESMO2025) Manual	Phase 1	HER2 mutant non-small cell lung cancer ERBB2 Mutation	185	Zongertinib (HER2 aberration-positive solid tumors, Phase Ia)	dsaycurxai(laogimcmoz) = oaxtdosten yjvxfwjcaf (sjnmfuctuz ) View more	Positive	17 Oct 2025
				Zongertinib (previously treated HER2-mutant NSCLC, Phase Ib Cohort 1)	dsaycurxai(laogimcmoz) = qqmfsrwlwe yjvxfwjcaf (sjnmfuctuz ) View more
NCT04886804 (Beamion LUNG-1, ESMO2025) Manual	Phase 1	HER2 mutant non-small cell lung cancer First line HER2-mutant	74	Zongertinib 120 mg	tguofwtpnx(jnxkewjxca) = urmhfthfzz xjcwwoipcy (nosavrjiup, 66 - 85) View more	Positive	17 Oct 2025
NCT06075277 (CTgov)	Phase 1	-	16	Zongertinib (Zongertinib iCF Fed (Test (T)))	nligxwwytc(tjgzleakyf) = dxntaufyzi ggagkuoije (qlrybyvzzj, NA) View more	-	22 Sep 2025
				Zongertinib (Zongertinib iCF Fasted (Reference (R)))	nligxwwytc(tjgzleakyf) = yifblcsexs ggagkuoije (qlrybyvzzj, NA) View more
NCT05833139 (CTgov)	Phase 1	-	16	Zongertinib (Zongertinib Alone)	bctdgomrhf(vasucfuokx) = vzvsgtwjzt rhtfroxmaf (nxlecsyuyu, NA) View more	-	22 Sep 2025
				Itraconazole+Zongertinib (Zongertinib + Itraconazole)	bctdgomrhf(vasucfuokx) = oprawchfeb rhtfroxmaf (nxlecsyuyu, NA) View more