A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
18 Years and older, Male and Female
22615 (primary)
NCI-2024-08200
2024-511319-91-00
Summary
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.
Eligibility
- Participant must be =18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.
- Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).
- Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.
- No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening.
- Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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