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) (NCT06452277)
A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Patty & George Hoag Cancer Center — Newport Beach, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (270 Sites)
Showing the first 25 of 270 sites.
- Patty & George Hoag Cancer Center — Newport Beach, California
- UC San Diego Health - Moores Cancer Center — San Diego, California
- UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology — San Francisco, California
- UCLA Health Santa Monica Cancer Care — Santa Monica, California
- The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street — Fort Lauderdale, Florida
- Memorial Cancer Institute at Miramar — Miramar, Florida
- AdventHealth Cancer Institute Orlando — Orlando, Florida
- Moffitt Cancer Center - Magnolia Campus — Tampa, Florida
- Piedmont Healthcare - Atlanta — Atlanta, Georgia
- John B. Amos Cancer Center — Columbus, Georgia
- University of Illinois Hospital - Outpatient Cancer Care Center — Chicago, Illinois
- The University of Chicago Medical Center - Hyde Park - Hematology & Oncology — Chicago, Illinois
- UM Greenebaum Comprehensive Cancer Center — Baltimore, Maryland
- UMass Memorial Medical Center - University Campus - Hematology/Oncology — Worcester, Massachusetts
- Profound Research -OMG - TriAtria Cancer Center — Farmington Hills, Michigan
- Profound Research - OMG - Royal Oak Cancer Center — Royal Oak, Michigan
- M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center — Minneapolis, Minnesota
- R.J. Zuckerberg Cancer Center — New Hyde Park, New York
- UC Medical Center - Oncology — Cincinnati, Ohio
- Taylor Cancer Research Center — Maumee, Ohio
- Providence Cancer Institute - Franz Clinic — Portland, Oregon
- Providence Oncology and Hematology Care Clinic Westside — Portland, Oregon
- Allegheny General Hospital — Pittsburgh, Pennsylvania
- The University of Texas MD Anderson Cancer Center - Texas Medical Center — Houston, Texas
- Instituto Argentino de Diagnostico y Tratamiento (IADT) — TBC, Buenos Aires
📞 Contact the Study Coordinator
Phone: (888) 842-2937
Email: clinical-trials-contact@bayer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Advanced Non-small Cell Lung Cancer, HER2 Mutation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.