At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sevabertinib (drug), Pembrolizumab (drug), Cisplatin (drug), Carboplatin (drug)
- How long the study runs
- Study runs about 58 months (dates as stated)
- About the drug or intervention
- Sevabertinib — drug: Tablet, oral · Pembrolizumab — drug: Intravenous (IV) infusion · Cisplatin — drug: IV infusion · Carboplatin — drug: IV infusion · Pemetrexed — drug: IV infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 555
- Started
- 2024-08-28
- Last checked
- 2026-09-09
Plain English Summary
What is this study?
- • Testing a new treatment for advanced non-small cell lung cancer, her2 mutation
- • Phase3 - 555 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced non-small cell lung cancer, her2 mutation
Where?
- • Torquay - Torbay Hospital | Oncology
- • Belfast - Belfast City Hospital | Oncology
- • Guildford - Royal Surrey County Hospital | Cancer Centre
- • Cardiff - Velindre Cancer Centre | Clinical Trials Unit
This is a simplified summary. Always discuss with your doctor before making any decisions.
About 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 means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly. The study treatment, sevabertinib, is designed to block the mutated HER2 protein and may help slow or stop the cancer from growing. The main purpose of this study is to find out how well sevabertinib works and how safe it is, compared with standard treatment in participants with advanced NSCLC with a HER2 mutation. The study participants will receive one of the study treatments: * Sevabertinib as a tablet taken by mouth twice a day * Standard approved treatment for this condition given by infusion into a vein every 21 days Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant assigned to the standard treatment has their cancer gets worse, they may have the opportunity to switch to receive sevabertinib. This switch is called a crossover. Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment. During the study, the research team will: * do scans such as CT, PET, MRI, or X-rays to check the cancer * Check the overall health of the participants by performing tests such as blood and urine tests and checking heart health using an electrocardiogram and echocardiogram. * do pregnancy tests when needed * ask how the participants are feeling and whether they have had any adverse events or other health problems 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a HER2 ex20ins-targeted therapy (e
What the study is looking for
- ✓Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18...
Who cannot take part
- ✗a. in situ cancers of cervix, breast, or skin,
- ✗b. superficial bladder cancer (Ta, Tis and T1),
- ✗c. limited-stage prostate cancer,
- ✗d. basal or squamous cancers of the skin.
- ✗Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.
See the full criteria
Where Is This Study? (4 UK sites)
Torbay Hospital | Oncology
Torquay TQ2 7AA, United Kingdom
Belfast City Hospital | Oncology
Belfast BT12 7AB, United Kingdom
Royal Surrey County Hospital | Cancer Centre
Guildford GU2 7XX, United Kingdom
Velindre Cancer Centre | Clinical Trials Unit
Cardiff CF14 2TL, United Kingdom
How to Get in Touch
Bayer Clinical Trials Contact
Sponsor contactCONTACT
