Lung Cancer, Non-squamous, Non-small CellPhase 2NCT07486817
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
A Phase 2 study testing Zongertinib, Cisplatin and Carboplatin in people with Lung Cancer, Non-squamous, Non-small Cell, run by Boehringer Ingelheim at 17 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-squamous, Non-small Cell
- What is being tested?
- Zongertinib, Cisplatin and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 4 Jun 2026to 25 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous non-small cell lung cancer (NSCLC)
- Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result
- An archival tumor tissue sample must be submitted to the central laboratory after randomization to retrospectively confirm the HER2 status
- Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease
- Presence of at least one measurable non-Central Nervous System (CNS) lesion according to response evaluation criteria in solid tumors (RECIST) 1.1
- Eligible to receive treatment with the selected platinum based doublet chemotherapy and pembrolizumab in accordance with the summary of product characteristics (SmPC)/Product Information
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Further inclusion criteria apply.
Who cannot join
- Tumors with targetable alterations with approved available therapy
- Presence or history of leptomeningeal disease
- 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
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening
- 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
- Previous therapy with a HER2-directed agent
- 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.
Trial locations and contacts
17 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 7 countries
Australia3 sites, 3 recruiting
- Recruiting
Cabrini Health
Malvern, Victoria, 3144
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Not yet recruiting
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
South Korea3 sites, 3 recruiting
- Recruiting
Severance Hospital
Seoul, 03722
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Asan Medical Center
Seoul, 05505
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Samsung Medical Center
Seoul, 06351
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Virgen del Rocío
Seville, 41013
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
China2 sites, 2 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, 510080
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai Geriatric Medical Center
Shanghai, 201104
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
France2 sites, 2 recruiting
- Recruiting
CTR Leon Berard
Lyon, 69373
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
INS Curie
Paris, 75005
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Köln (AöR)
Cologne, 50937
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Japan2 sites, 2 recruiting
- Recruiting
Kindai University Hospital
Osaka, Sakai, 590-0197
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
About this study
Official title: 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.
Read more
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.
- Being tested
- Zongertinib, Cisplatin, Carboplatin, Pemetrexed, Pembrolizumab
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZongertinibDrug
Also called Hernexeos®
Zongertinib
CisplatinDrug
Cisplatin
CarboplatinDrug
Carboplatin
PemetrexedDrug
Pemetrexed
PembrolizumabDrug
Pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| Arm A: zongertinib + cisplatin or carboplatin and pemetrexed | Experimental | Not described Receives: Drug: Zongertinib; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed |
| Arm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab | Experimental | Not described Receives: Drug: Zongertinib; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 weeks
Secondary outcomes (10)
Occurrence of serious adverse events (SAE) during the on-treatment period
Measured: up to 1.5 years
Occurrence of dose reduction of zongertinib
Measured: 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
Measured: up to 1.5 years
Occurrence of Grade ≥3 non-hematological AE during the on-treatment period
Measured: up to 1.5 years
Occurrence of combination limiting toxicities (CLTs) during the on-treatment period
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
Measured: up to 1.5 years
Objective response (OR) according to Response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by the investigator
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start4 Jun 2026
- Primary completion12 Aug 2027 (estimated)
- Study completion25 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-squamous, Non-small CellStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486817
- Sponsor's protocol ID
- 1479-0044
- Other IDs
- 2025-523567-38-00, U1111-1327-3020, 2025
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07486817
- Acronym / sponsor ID
- 1479-0044
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 12 Aug 2027 (estimated)
- Study completion
- 25 Aug 2029 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: zongertinib + cisplatin or carboplatin and pemetrexed | Experimental | Drug: Zongertinib, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed |
| Arm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab | Experimental | Drug: Zongertinib, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Drug: Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
- Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous non-small cell lung cancer (NSCLC)
- Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result
- An archival tumor tissue sample must be submitted to the central laboratory after randomization to retrospectively confirm the HER2 status
- Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease
Key exclusion criteria (7 listed)
- Tumors with targetable alterations with approved available therapy
- Presence or history of leptomeningeal disease
- 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
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZongertinibAlso: Hernexeos®Zongertinib | Drug | Arm A: zongertinib + cisplatin or carboplatin and pemetrexed, Arm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab |
| CisplatinCisplatin | Drug | Arm A: zongertinib + cisplatin or carboplatin and pemetrexed, Arm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab |
| CarboplatinCarboplatin | Drug | Arm A: zongertinib + cisplatin or carboplatin and pemetrexed, Arm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab |
| PemetrexedPemetrexed | Drug | Arm A: zongertinib + cisplatin or carboplatin and pemetrexed, Arm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab |
| PembrolizumabPembrolizumab | Drug | Arm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumab |
Primary outcome
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
10 secondary outcomes
Occurrence of serious adverse events (SAE) during the on-treatment period
Time frame: up to 1.5 years
Occurrence of dose reduction of zongertinib
Time frame: 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
Occurrence of Grade ≥3 non-hematological AE during the on-treatment period
Time frame: up to 1.5 years
Occurrence of combination limiting toxicities (CLTs) during the on-treatment period
Time frame: 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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zongertinib, Cisplatin and Carboplatin in people with Lung Cancer, Non-squamous, Non-small Cell, run by Boehringer Ingelheim at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Australia, South Korea, Spain, China, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (18002430127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.