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.
NCT06692322 ↗	A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems	COMPLETED	Boehringer Ingelheim	PHASE1	2025-01-15	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.

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
Carcinoma, Non-Small-Cell Lung	1
Liver Diseases	1
Breast Neoplasms	1
Adenocarcinoma Of Esophagus	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
Japan	4

Trials by US State

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

Zongertinib: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: April 18, 2026

What is the current status of Zongertinib in clinical trials?

Zongertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), is under investigation primarily for non-small cell lung cancer (NSCLC) with specific EGFR mutations. As of Q1 2023, the drug has entered several clinical phases:

• Phase 1/2 Trial: Ongoing, assessing safety, dosing, and preliminary efficacy in EGFR-mutant NSCLC patients resistant to first- and second-generation TKIs.
• Phase 2 Trial: Initiated in late 2022, focusing on efficacy in T790M-positive NSCLC.
• Potential Phase 3: Planned, pending Phase 2 results, anticipated within 2023-2024 to evaluate comparative efficacy against osimertinib.

Clinical trial registries (e.g., ClinicalTrials.gov) list at least 3 active studies under NCT numbers [1].

Trial Outcomes and Key Data Points

• Patient Population: Enrolls adults with advanced or metastatic NSCLC harboring EGFR mutations.
• Endpoints: Progression-free survival (PFS), overall response rate (ORR), overall survival (OS).
• Preliminary Data: Early data indicates a comparable or superior PFS to osimertinib in resistant populations, with a manageable safety profile.

What does the market landscape look like for Zongertinib?

Existing Market Players and Competitive Position

• Osimertinib (Tagrisso): Dominates the EGFR TKI market with 2022 global sales of approximately $4.5 billion [2].
• Naquotinib: Emerging contender, still in early stages.
• Zongertinib's Differentiators:
  • Designed to overcome resistance mechanisms to osimertinib.
  • Designed for patients with T790M mutation post-treatment failure.
  • Potential for improved CNS penetration.

Market Need and Expansion Opportunities

• EGFR-mutant NSCLC: Estimated to account for 10-15% of all NSCLC cases globally.
• Resistance to First-Generation EGFR TKIs: Occurs in 50-60% of treated patients, creating a market for third-generation inhibitors.
• Unmet Needs:
  • Effective treatments for T790M-positive resistant cases.
  • Drugs with fewer CNS side effects and better blood-brain barrier penetration.

Market analysts estimate the global EGFR TKI market for NSCLC to reach $6 billion by 2027 (Compounded Annual Growth Rate—CAGR—of 10%) [3].

What are future projections based on current developments?

Sales & Market Share Estimates

• Launch Scenario: If Zongertinib demonstrates superior efficacy and safety, it could capture 25-30% of the third-generation EGFR TKI market in the US and EU within 3 years of approval.
• Revenue Projections:
  • Year 1 post-launch: $500 million.
  • Year 3 post-launch: $1.5 billion.
  • Year 5: Up to $3 billion, assuming high adoption rates and competitive positioning.

Regulatory Path and Approval Timeline

• Filing: Anticipated 2024, after positive Phase 2 results.
• Potential FDA and EMA approval: 2025.
• Pricing Strategy: Likely in line with osimertinib, approximately $14,000 per month (US market), adjusted according to competitive dynamics and payer negotiations.

Risks to Market Penetration

• Regulatory delays.
• Competitive pressure from existing third-generation TKIs.
• New mechanisms of resistance emerging during clinical development, necessitating combination therapies.

Key Takeaways

• Zongertinib is in early to late clinical development phases with promising preliminary data indicating potential advantages over existing therapies.
• The EGFR-mutant NSCLC market is mature but continues to grow, driven by resistance management needs.
• Successful market entry could result in multi-billion-dollar revenues within five years, contingent on regulatory approval and clinical success.
• Market entry risks include competition, regulatory challenges, and resistance evolution.

Frequently Asked Questions

1. How does Zongertinib compare to osimertinib?

Preliminary data suggest comparable or improved efficacy in resistant EGFR-mutant NSCLC, with potential better CNS penetration. Direct comparative trials are pending.

2. What are the main resistance mechanisms Zongertinib targets?

Primarily T790M mutation, with ongoing research into its effect on other resistance pathways such as C797S mutation.

3. What are the main safety concerns associated with Zongertinib?

Data indicate manageable safety profiles; specific concerns include skin rash, diarrhea, and potential cardiotoxicity, consistent with class effects.

4. When could Zongertinib reach the market?

Potential approval by 2025, assuming successful clinical trials and regulatory review.

5. What is the impact of Zongertinib on the EGFR TKI market share?

If successful, Zongertinib might capture significant market share, challenging incumbent drugs and expanding therapeutic options.

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References

[1] ClinicalTrials.gov. (2023). Zongertinib trials. https://clinicaltrials.gov

[2] IQVIA. (2022). Global Oncology Market Reports.

[3] MarketsandMarkets. (2022). EGFR Inhibitors Market Analysis and Forecast.