BAY2927088 for Non-Small Cell Lung Cancer
(SOHO-02 Trial)
Trial Summary
What is the purpose of this trial?
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division. The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC. The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations. The study participants will receive one of the study treatments: * BAY 2927088 twice every day as a tablet by mouth, or * Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment. During the study, the doctors and their study team will: * take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer * check the overall health of the participants by performing tests such as blood and urine tests, and checking * heart health using an electrocardiogram (ECG) * perform pregnancy tests for women * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are unable to stop chronic systemic corticosteroids. Other medications may be allowed, but it's best to discuss your specific situation with the study team.
What data supports the effectiveness of the drug BAY 2927088 for non-small cell lung cancer?
What makes the drug BAY2927088 unique for treating non-small cell lung cancer?
Eligibility Criteria
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has spread and has specific HER2 gene mutations. Participants must be able to take oral medication and undergo regular health checks, imaging scans, and possibly pregnancy tests.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BAY 2927088 twice daily as a tablet by mouth or standard treatment in 21-day cycles via infusion until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BAY 2927088
BAY 2927088 is already approved in United States for the following indications:
- Non-small cell lung cancer (NSCLC) with HER2 mutations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD