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Study identifier: NCT06452277 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study to Learn More About How Well Sevabertinib 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)

Condition: Advanced Non-small Cell Lung Cancer, HER2 Mutation  ·  Sponsor: Bayer

PhasePhase 3
Planned participants444
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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, sevabertinib, 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 sevabertinib 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: * Sevabertinib twice every day as a tablet by mouth, or * Standard treatment in cycles of 21 days via infusion ("drip") into the vein. * 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 receiving the standard treatment has their disease get worse (this is called "disease progression"), they may have the…

This description comes directly from the study's public registry record.

Talk to the study team

Bayer Clinical Trials Contact  ·  (+)1-888-84 22937  ·  clinical-trials-contact@bayer.com

Always discuss trial participation with your own doctor first.

Locations (285)

Patty & George Hoag Cancer CenterNewport Beach, California, United StatesWithdrawn
UC San Diego Health - Moores Cancer CenterSan Diego, California, United StatesRecruiting
UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and OncologySan Francisco, California, United StatesRecruiting
UCLA Health Santa Monica Cancer CareSanta Monica, California, United StatesRecruiting
The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th StreetFort Lauderdale, Florida, United StatesRecruiting
Memorial Cancer Institute at MiramarMiramar, Florida, United StatesRecruiting
AdventHealth Cancer Institute OrlandoOrlando, Florida, United StatesRecruiting
Moffitt Cancer Center - Magnolia CampusTampa, Florida, United StatesRecruiting
Moffitt Cancer CenterTampa, Florida, United StatesNot Yet Recruiting
Piedmont Healthcare - AtlantaAtlanta, Georgia, United StatesRecruiting
John B. Amos Cancer CenterColumbus, Georgia, United StatesRecruiting
University of Illinois Hospital - Outpatient Cancer Care CenterChicago, Illinois, United StatesRecruiting

+ 273 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06452277