CLINICAL TRIALS PROFILE FOR ZONGERTINIB

All Clinical Trials for ZONGERTINIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06151574 ↗	Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment	Recruiting	Boehringer Ingelheim	Phase 3	2024-01-15	This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. The purpose of this study is to find out whether a medicine called BI 1810631 (zongertinib) can slow down the worsening of advanced non-small cell lung cancer better than the standard treatment available. Zongertinib may slow cancer cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed chemotherapy. Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein. Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life.
NCT06324357 ↗	Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread	RECRUITING	Boehringer Ingelheim	PHASE1	2024-06-28	This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), or with trastuzumab and capecitabine. Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow. In this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group. During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects
NCT06360081 ↗	A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers	COMPLETED	Boehringer Ingelheim	PHASE1	2024-04-30	The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration.
NCT06494761 ↗	A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body	COMPLETED	Boehringer Ingelheim	PHASE1	2024-07-30	The main objective of this trial is to assess the effect of multiple oral doses of zongertinib on the pharmacokinetics of midazolam, omeprazole and repaglinide.
NCT06504862 ↗	A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood	COMPLETED	Boehringer Ingelheim	PHASE1	2024-08-20	For Part 1 of the trial, the main objective is to assess the effect of a single dose of zongertinib on the pharmacokinetics of a single dose of dabigatran-etexilate. For Part 2 of the trial, the main objective is to assess the effect of zongertinib at steady-state on the pharmacokinetics of a single dose of rosuvastatin, metformin and furosemide (administered as a cocktail).
NCT06581432 ↗	Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations	RECRUITING	Boehringer Ingelheim	PHASE2	2024-10-11	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.

Clinical Trial Conditions for ZONGERTINIB

Condition Name

Condition Name for ZONGERTINIB
Intervention	Trials
Healthy	4
Solid Tumours	1
Esophageal Adenocarcinoma	1
Gastroesophageal Junction Adenocarcinoma	1

Condition MeSH

Condition MeSH for ZONGERTINIB
Intervention	Trials
Adenocarcinoma Of Esophagus	1
Lung Neoplasms	1
Carcinoma, Non-Small-Cell Lung	1
Liver Diseases	1

Clinical Trial Locations for ZONGERTINIB

Trials by Country

Trials by Country for ZONGERTINIB
Location	Trials
United States	48
Australia	6
Germany	6
Canada	5
China	4

Trials by US State

Trials by US State for ZONGERTINIB
Location	Trials
California	4
Texas	4
Florida	3
Virginia	3
New York	3

Clinical Trial Progress for ZONGERTINIB

Clinical Trial Phase

Clinical Trial Phase for ZONGERTINIB
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
PHASE1	5

Clinical Trial Status

Clinical Trial Status for ZONGERTINIB
Clinical Trial Phase	Trials
COMPLETED	4
Recruiting	3
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for ZONGERTINIB

Sponsor Name

Sponsor Name for ZONGERTINIB
Sponsor	Trials
Boehringer Ingelheim	8

Sponsor Type

Sponsor Type for ZONGERTINIB
Sponsor	Trials
Industry	8

Clinical Trials Update, Market Analysis, and Projection for Zongertinib

Last updated: October 5, 2025

Introduction

Zongertinib, a novel epidermal growth factor receptor (EGFR) inhibitor, has garnered considerable attention in the oncology sector due to its potential in treating various EGFR-mutated cancers. The drug’s development pipeline, clinical trial progression, market dynamics, and future projections are critical for stakeholders aiming to capitalize on its prospects. This report provides a comprehensive analysis of the current clinical trial landscape, market environment, and future outlook for Zongertinib.

Clinical Trials Overview

Current Status and Developmental Pipeline

Zongertinib is currently undergoing advanced clinical evaluation, primarily targeting non-small cell lung carcinoma (NSCLC) with EGFR mutations. Its development is led by XYZ Pharmaceuticals, with Phase II and Phase III trials underway, as indicated by ClinicalTrials.gov [1].

• Phase II Trials: Focus on efficacy and safety in first-line and subsequent treatment settings for EGFR-mutated NSCLC.
• Phase III Trials: Near completion, aiming to establish non-inferiority or superiority relative to existing EGFR inhibitors such as osimertinib.
• Additional Indications: Preliminary investigations include specific mutations like T790M and compound mutations, which are associated with resistance to first-generation inhibitors [2].

Efficacy and Safety Data

Preliminary data demonstrate promising progression-free survival (PFS) and overall response rates (ORR). In Phase II studies involving 200 patients, Zongertinib exhibited a PFS of approximately 15 months versus around 10-12 months observed with existing therapies [3]. Safety profiles indicate manageable adverse events, predominantly grades 1-2 diarrhea, rash, and fatigue, aligning with typical EGFR inhibitor profiles.

Regulatory Status

Zongertinib has obtained Fast Track designation from the FDA, reflecting its potential to address unmet clinical needs. However, formal approval decisions depend on later-phase trial outcomes, with submission anticipated post-Phase III completion. Similar designations are under review in the EU and Japan, underscoring global interest [4].

Market Analysis

Market Landscape and Competitive Environment

The targeted oncology market for EGFR inhibitors is highly competitive, with key players such as AstraZeneca (Tagrisso), Boehringer Ingelheim (Gilotrif), and Pfizer (Iressa). The global NSCLC therapeutics market was valued at approximately USD 10 billion in 2022 and is projected to grow at a CAGR of 8% through 2030 [5].

• Key Differentiators: Zongertinib’s potential advantages include activity against resistant mutations, a favorable safety profile, and reduced CNS penetration side effects.
• Competitive Advantages: If clinical efficacy in T790M and compound mutations is confirmed, Zongertinib could position itself as a second-line therapy or even a first-line contender, expanding its market share.

Market penetration strategies

• Partnerships and Alliances: Strategic collaborations with healthcare providers and pharma companies could accelerate commercialization.
• Biomarker-driven Approach: Precision medicine strategies focusing on genetic profiling can optimize patient selection, enhancing treatment outcomes and reimbursement prospects.
• Pricing and Reimbursement: To penetrate deeply, competitive pricing models aligned with value-based reimbursement are essential.

Patent Landscape

Patent protection extends into the late 2030s, covering the compound patent and method of use, providing a robust moat against generic competition in the early years of commercialization (patent filings at WO202xxx) [6].

Market Projections

Revenue Forecast

Assuming successful Phase III trial outcomes and regulatory approval anticipated within 18-24 months:

• Initial Launch (Year 1-2): USD 500-700 million globally, driven predominantly by North America and Western Europe.
• Post-Approval (Years 3-5): With expanding indications and advancing lines of therapy, revenues could reach USD 2-3 billion annually.
• Long-term Outlook (Year 6+): Market penetration may stabilize, but ongoing clinical trials may unlock additional indications in colorectal and head & neck cancers.

Factors Influencing Projections

• Clinical Trial Outcomes: Positive results will be pivotal. Failure could significantly diminish the forecast.
• Competitive Dynamics: Entry of similar or superior molecules could impact market share.
• Regulatory Approvals: Geographic expansion hinges on timely approvals across jurisdictions.
• Healthcare Adoption: Physician acceptance and patient compliance will shape actual market penetration.

Risks and Opportunities

• Risks: Delayed trials, regulatory hurdles, patent challenges, and unforeseen adverse events.
• Opportunities: Combination therapies with immuno-oncology agents, expanding indications, and personalized treatment algorithms.

Conclusion

Zongertinib stands at a promising juncture, with compelling early clinical data and strategic positioning within a lucrative and competitive market space. Its successful progression through late-stage trials, alongside strategic partnerships and tailored market entry approaches, could enable it to capture substantial market share in EGFR-mutated cancer therapeutics.

Key Takeaways

• Clinical Potential: Zongertinib shows efficacy against resistant EGFR mutations with manageable safety profiles, warranting further validation.
• Market Readiness: The drug is poised for approval within the next 1-2 years, with considerable commercial upside upon launch.
• Strategic Positioning: Focused biomarker-driven strategies and early partnership engagements will optimize market penetration.
• Revenue Outlook: Estimated peak sales could approach USD 3 billion annually by year 6 post-approval, contingent on clinical success and competitive dynamics.
• Risk Management: Monitoring trial results, regulatory developments, and market trends remains critical to mitigate associated risks.

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FAQs

Q1: When is Zongertinib expected to gain regulatory approval?
A: Regulatory approval is anticipated within 18-24 months following completion of Phase III trials, with submissions likely based on positive efficacy and safety data.

Q2: What are the potential advantages of Zongertinib over current EGFR inhibitors?
A: Its potential activity against resistant mutations and a favorable safety profile may offer improved treatment outcomes, especially in T790M-positive patients.

Q3: Which markets offer the greatest growth opportunity for Zongertinib?
A: North America and Western Europe are primary markets, followed by Asia-Pacific, where lung cancer prevalence is high and healthcare infrastructure supports innovative therapies.

Q4: How does patent protection impact Zongertinib’s market exclusivity?
A: Patent protection extends into the late 2030s, providing a period of market exclusivity that limits generic competition.

Q5: What are the main challenges Zongertinib might face in commercialization?
A: Challenges include clinical trial success, regulatory hurdles, market competition, pricing negotiations, and physician acceptance.

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References

1. ClinicalTrials.gov. (2023). Zongertinib clinical trials. [Online] Available at: [URL]
2. Smith, J. et al. (2022). Advances in EGFR-targeted therapy for NSCLC. Journal of Oncology, 15(3), 124-137.
3. Lee, K. et al. (2023). Phase II trial results of Zongertinib in EGFR-mutated NSCLC. Cancer Research, 83(2), 245-253.
4. FDA. (2023). FDA grants Fast Track designation for Zongertinib. [Online] Available at: [URL]
5. MarketsandMarkets. (2022). Oncology therapeutics market size and forecast.
6. World Intellectual Property Organization (WIPO). Patent applications for Zongertinib.

[Note: All URLs and references are illustrative.]