Beamion 44: A study to test how well zongertinib is tolerated by people with advanced non-small cell lung cancer with HER2 mutations when given in combination with chemotherapy with or without pembrolizumab

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

2 Jun 2026 → ongoing

Decision date (initial)

2026-05-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-523567-38-00

WHO UTN

U1111-1327-3020

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Therapy, Efficacy

The primary objective of the trial is to evaluate the safety and tolerability of zongertinib together with combination partners by assessing the occurrence of discontinuation and/or prolonged interruption of zongertinib due to treatment-related AEs in the first 2 cycles of treatment.

Secondary objectives 1

1. The secondary objectives are to further characterize the safety, tolerability, and preliminary efficacy of zongertinib together with combination partners.

Conditions and MedDRA coding

locally advanced or metastatic NSCLC

Regulatory references

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. Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF
2. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous NSCLC
3. Documented activating HER2 mutation as per existing local lab result
4. An archival tumor tissue sample must be submitted to the central laboratory after randomization to retrospectively confirm the HER2 status
5. Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease
6. Presence of at least one measurable non-CNS lesion according to RECIST 1.1.
7. Eligible to receive treatment with the selected platinum based doublet chemotherapy and pembrolizumab in accordance with the SmPC/Product Information
8. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
9. Further inclusion criteria apply.

Exclusion criteria 8

1. Tumors with targetable alterations with approved available therapy
2. Presence or history of leptomeningeal disease
3. Radiotherapy within 4 weeks prior to treatment start with exception of palliative radiotherapy to regions other than the chest if completed at least 2 weeks prior to treatment start
4. Major surgery (major according to the investigator’s assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening
5. Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug
6. Previous therapy with a HER2-directed agent
7. History or presence of cardiovascular abnormalities which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization
8. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related AEs in the first 2 cycles of treatment

Secondary endpoints 10

1. Occurrence of SAE during the on-treatment period
2. Occurrence of dose reduction of zongertinib
3. Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related AEs during the on-treatment period
4. Occurrence of Grade ≥3 non-hematological AE during the on-treatment period
5. Occurrence of combination limiting toxicities (CLTs) during the on-treatment period
6. Objective response (OR) according to RECIST 1.1 as assessed by the investigator, defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) from date of randomization until the earliest of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent
7. Time to OR, defined as the time from date of randomization to first documented confirmed CR or PR among patients with OR as determined by investigator assessment per RECIST 1.1
8. Duration of OR (DoR), defined as the time from first documented confirmed CR or PR until disease progression or death among patients with OR as determined by investigator assessment per RECIST 1.1
9. Progression-free survival (PFS), defined as the time from randomization until tumor progression according to RECIST 1.1 as assessed by the investigator, or death from any cause, whichever occurs earlier
10. Time on treatment (ToT), defined as the time from first dose of study treatment until zongertinib treatment discontinuation or death

Investigational products

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

Test 5

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

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

3 EU/EEA countries · 7 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 27 files

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

Application history

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