Advanced Non-small Cell Lung CancerNCT06761976
Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation
A study testing Sevabertinib in people with Advanced Non-small Cell Lung Cancer and Cancer, run by Bayer.
Trial summary
The purpose of this Expanded Access Program (EAP) is to provide access to sevabertinib, for participants previously treated with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human epidermal growth factor receptor 2 (HER2) gene, which have no other therapeutic option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer, Cancer
- What is being tested?
- Sevabertinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Signed and dated written informed consent
- Age ≥18 years
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- Documented disease progression after treatment with at least one prior systemic therapy for advanced disease
- Documented HER2 activating mutation
- Expected minimum life expectancy of 12 weeks
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- Performance status of 0 or 1
- Participants must be able to take oral medication
- Blood test results within certain ranges
- Adequate coagulation as assessed by lab tests or on stable anticoagulation treatment
- Adequate cardiac function
- Negative serum pregnancy test in women of childbearing potential within 72 hours of the first dose
- Ability to receive prescription of loperamide from the treating physician
Who cannot join
- Investigational agent or anticancer therapy within 2 weeks prior to planned start of sevabertinib or 5 half-lives, whichever is shorter, and without recovery of clinically significant toxicities from that therapy
- Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting HER2
- Symptomatic or unstable brain metastases
- Treatment with immunotherapy ≤ 28 days prior to the first dose of IMP
- Past medical history of Grade ≥2 ILD, drug-induced interstitial lung disease
- Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer prior to start of treatment initiation
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- Any uncontrolled intercurrent illness or condition including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, ongoing or active infection (including active clinical tuberculosis), renal transplant or psychiatric illness/social situations that would limit compliance
- Pregnancy or lactation
- History of clinically significant cardiac disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Expanded Access Program to Provide Oral Sevabertinib (BAY 2927088) in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring an HER2 (Human Epidermal Growth Factor Receptor 2) Activating Mutation
The purpose of this Expanded Access Program (EAP) is to provide access to sevabertinib, for participants previously treated with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human epidermal growth factor receptor 2 (HER2) gene, which have no other therapeutic option.
- Conditions
- Advanced Non-small Cell Lung Cancer, Cancer
- Being tested
- Sevabertinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevabertinibDrug
Also called BAY2927088
Sevabertinib is self-administered by the patient BID (twice a day) as tablets for oral administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761976
- Sponsor's protocol ID
- 22913
- Other IDs
- 22978
- Status last verified
- Jul 2026
- First submitted
- 30 Dec 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program to Provide Oral Sevabertinib (BAY 2927088) in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring an HER2 (Human Epidermal Growth Factor Receptor 2) Activating Mutation
- ClinicalTrials.gov ID
- NCT06761976
- Acronym / sponsor ID
- 22913
- Conditions
- Advanced Non-small Cell Lung Cancer, Cancer
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- First posted
- 7 Jan 2025 (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.
The purpose of this Expanded Access Program (EAP) is to provide access to sevabertinib, for participants previously treated with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human epidermal growth factor receptor 2 (HER2) gene, which have no other therapeutic option.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed and dated written informed consent
- Age ≥18 years
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- Documented disease progression after treatment with at least one prior systemic therapy for advanced disease
- Documented HER2 activating mutation
Key exclusion criteria (9 listed)
- Investigational agent or anticancer therapy within 2 weeks prior to planned start of sevabertinib or 5 half-lives, whichever is shorter, and without recovery of clinically significant toxicities from that therapy
- Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting HER2
- Symptomatic or unstable brain metastases
- Treatment with immunotherapy ≤ 28 days prior to the first dose of IMP
- Past medical history of Grade ≥2 ILD, drug-induced interstitial lung disease
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 |
|---|---|---|
| SevabertinibAlso: BAY2927088Sevabertinib is self-administered by the patient BID (twice a day) as tablets for oral administration | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Sevabertinib in people with Advanced Non-small Cell Lung Cancer and Cancer, run by Bayer.
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 13 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 7 Jul 2026.