Beamion LUNG-3: A study to test whether zongertinib helps people with surgically removed, non-small cell lung cancer with HER2 mutations compared with standard treatment

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

5 Mar 2026 → ongoing

Decision date (initial)

2026-01-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-521284-12-00

WHO UTN

U1111-1320-6149

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Safety

The primary objective of the trial is to demonstrate superiority of zongertinib over SoC based on the log-rank test on DFS.

Secondary objectives 2

1. The key secondary objective is to demonstrate superiority of zongertinib over SoC based on the log-rank test on overall survival (OS).
2. Secondary objectives are to evaluate additional efficacy parameters and safety of zongertinib compared with SoC.

Conditions and MedDRA coding

Non-small cell lung cancer

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-003546-PIP01-23

Plan to share IPD

Yes

IPD plan description

Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed “Document Sharing Agreement”. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website. Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program. Access Criteria: For study documents – upon signing of a ‚Document Sharing Agreement‘. For study data – 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
2. 2. Patients must be ≥18 years old or over the legal age of consent in their country
3. 3. Male or female patients. Women of childbearing potential (WOCBP)1 must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol
4. 4. HER2 mutation: Documented TKD activating HER2 mutations
5. 5. Histology and tumor sample: - Histologically confirmed diagnosis of primary NSCLC
6. 6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status
7. 7. Staging: Pretherapeutic classification not exceeding Stage IIIB
8. 8. Performance status and organ function: - Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 - Adequate organ function based on laboratory values
9. Further inclusion criteria apply.

Exclusion criteria 7

1. 1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
2. 2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
3. 3. Treatment with […] radiation therapy for primary NSCLC
4. 4. Co-occurring actionable mutation with approved targeted therapy (e.g. EGFR or ALK)
5. 5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known
6. 6. History or presence of - Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis - Active infectious disease requiring systemic therapy - Uncontrolled gastrointestinal disorders affecting drug intake/absorption - Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers - Significant and/or uncontrolled cardiovascular abnormalities, QTcF >470 msec, or ejection fraction <50%
7. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. DFS by investigator's assessment. DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier

Secondary endpoints 2

1. OS, defined as the time from randomization until death from any cause
2. Occurrence of trial-related AEs ≥ Grade 3, graded according to CTCAE version 5.0, from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Third parties 2

Boehringer Ingelheim Espana S.A.

Sponsor organisation

Boehringer Ingelheim Espana S.A.

Address

Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles

City

Barcelona

Postcode

08174

Country

Spain

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

12 EU/EEA countries · 59 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 119 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications