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

May 18, 2026 updated by: Boehringer Ingelheim

Beamion 44: A Randomized, Open-label, Multi-center Phase IIa Platform Trial to Evaluate the Safety and Tolerability of Zongertinib Plus Platinum-based Doublet Chemotherapy With or Without Pembrolizumab (and Potential Other Combinations) in Treatment-naïve Patients With Locally Advanced/Metastatic Non-squamous NSCLC With Activating HER2 Mutations

This study is open to adults with a type of lung cancer called HER2-mutant non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread. People who have a tumor with a HER2 mutation and have not received previous treatment for their lung cancer can participate in the study. The purpose of this study is to find out how well a medicine called zongertinib is tolerated in people with this type of lung cancer, when combined with chemotherapy, with or without pembrolizumab. Zongertinib works by targeting and blocking HER2, a protein involved in cancer cell growth.

Participants are put into two groups randomly, which means by chance. One group gets zongertinib tablets combined with platinum-based chemotherapy. The other group gets the same treatment plus an additional medicine called pembrolizumab. Chemotherapy and pembrolizumab are given as an infusion into a vein. Participants take zongertinib by mouth once a day, while chemotherapy is given every 3 weeks for up to 3 months, followed by maintenance treatment for up to 2 years.

Pembrolizumab is given every 3 weeks for up to 2 years.

This study does not have a fixed duration. Participants can receive some of the study treatments for up to about 2 years and may continue to take zongertinib as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. Doctors regularly check the size of the tumor and whether it has spread. They also monitor participants' health and take note of any unwanted effects.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
    • Victoria
      • Malvern, Victoria, Australia, 3144
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
  • China
      • Guangzhou, China, 510080
        • Guangdong Provincial People's Hospital
        • Contact:
      • Shanghai, China, 201104
        • Shanghai Geriatric Medical Center
        • Contact:
  • France
  • Germany
      • Cologne, Germany, 50937
      • Heidelberg, Germany, 69126
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
        • Contact:
  • Japan
      • Osaka, Sakai, Japan, 590-0197
      • Tokyo, Chuo-ku, Japan, 104-0045
  • South Korea
      • Seoul, South Korea, 05505
      • Seoul, South Korea, 06351
      • Seoul, South Korea, 03722
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebrón
        • Contact:
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Seville, Spain, 41013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  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 informed consent form (ICF)
  2. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous non-small cell lung cancer (NSCLC)
  3. Documented activating human epidermal growth factor receptor 2 (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-Central Nervous System (CNS) lesion according to response evaluation criteria in solid tumors (RECIST) 1.1
  7. Eligible to receive treatment with the selected platinum based doublet chemotherapy and pembrolizumab in accordance with the summary of product characteristics (SmPC)/Product Information
  8. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Further inclusion criteria apply.

Exclusion criteria:

  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 Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: zongertinib + cisplatin or carboplatin and pemetrexed
Drug: Cisplatin
Cisplatin
Drug: Carboplatin
Carboplatin
Drug: Pemetrexed
Pemetrexed
Drug: Zongertinib
Zongertinib
Other Names:
  • Hernexeos®
Experimental: Arm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab
Drug: Pembrolizumab
Pembrolizumab
Drug: Cisplatin
Cisplatin
Drug: Carboplatin
Carboplatin
Drug: Pemetrexed
Pemetrexed
Drug: Zongertinib
Zongertinib
Other Names:
  • Hernexeos®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related adverse events (AEs) in the first 2 cycles of treatment
Time Frame: up to 6 weeks
up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of serious adverse events (SAE) during the on-treatment period
Time Frame: up to 1.5 years
up to 1.5 years
Occurrence of dose reduction of zongertinib
Time Frame: up to 1.5 years
up to 1.5 years
Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related AEs during the on-treatment period
Time Frame: up to 1.5 years
up to 1.5 years
Occurrence of Grade ≥3 non-hematological AE during the on-treatment period
Time Frame: up to 1.5 years
up to 1.5 years
Occurrence of combination limiting toxicities (CLTs) during the on-treatment period
Time Frame: up to 1.5 years

Specific adverse events (AEs) are classified as combination limiting toxicities (CLTs) in the study protocol, e.g.:

  • laboratory parameters that exceed predefined limits as defined in the study protocol *
  • Treatment-related death (other than death related to progressive disease)
  • Any AE which causes an interruption or delay to treatment with zongertinib of greater than 7 days
  • Any AE that requires treatment discontinuation of zongertinib in accordance with the study protocol
up to 1.5 years
Objective response (OR) according to Response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by the investigator
Time Frame: up to 1.5 years
OR is 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
up to 1.5 years
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
Time Frame: up to 1.5 years
up to 1.5 years
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
Time Frame: up to 1.5 years
up to 1.5 years
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
Time Frame: up to 1.5 years
up to 1.5 years
Time on treatment (ToT), defined as the time from first dose of study treatment until zongertinib treatment discontinuation or death
Time Frame: up to 1.5 years
up to 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 22, 2026

Primary Completion (Estimated)

August 12, 2027

Study Completion (Estimated)

August 25, 2029

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1479-0044
  • 2025-523567-38-00 (Ctis)
  • U1111-1327-3020 (Registry Identifier: WHO ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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