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NCT06452277 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn More About How Well Sevabertinib (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)
A Phase 3 study of Advanced Non-Small-Cell Lung Cancer and HER2 Mutation, sponsored by Bayer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 278
- Enrollment target
- 20
- Study locations
NCT06452277 is a Phase 3 study of Advanced Non-Small-Cell Lung Cancer and HER2 Mutation that is actively recruiting participants, run by Bayer. The registered enrollment target is 278 participants, below the 370-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT06452277, a Phase 3 study of Advanced Non-Small-Cell Lung Cancer and HER2 Mutation, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 278 participants
- Enrollment target
- 20
- Study locations
Study 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 treatmen
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG BAY2927088
Study Locations (20)
Florida
- The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street - Fort Lauderdale
- Memorial Cancer Institute at Miramar - Miramar
- AdventHealth Cancer Institute Orlando - Orlando
- Moffitt Cancer Center - Magnolia Campus - Tampa
- Moffitt Cancer Center - Tampa
California
- Patty & George Hoag Cancer Center - Newport Beach
- UC San Diego Health - Moores Cancer Center - San Diego
- UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology - San Francisco
- UCLA Health Santa Monica Cancer Care - Santa Monica
Georgia
- Piedmont Healthcare - Atlanta - Atlanta
- John B. Amos Cancer Center - Columbus
Illinois
- University of Illinois Hospital - Outpatient Cancer Care Center - Chicago
- The University of Chicago Medical Center - Hyde Park - Hematology & Oncology - Chicago
Michigan
- Profound Research -OMG - TriAtria Cancer Center - Farmington Hills
- Profound Research - OMG - Royal Oak Cancer Center - Royal Oak
Maryland
- UM Greenebaum Comprehensive Cancer Center - Baltimore
Massachusetts
- UMass Memorial Medical Center - University Campus - Hematology/Oncology - Worcester
Minnesota
- M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2024-08-28 |
| Est. Completion | 2029-06-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06452277
The ClinicalTrials.gov registry entry for NCT06452277 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 278 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 370-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target (25% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Advanced Non-Small-Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06452277 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06452277 about?
NCT06452277 is a clinical study titled "A Study to Learn More About How Well Sevabertinib (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)". 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 part...
What is the current status of trial NCT06452277?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 278 participants. The study started on 2024-08-28. Estimated completion is 2029-06-27.
What conditions does trial NCT06452277 study?
This clinical trial studies the following conditions: Advanced Non-Small-Cell Lung Cancer, HER2 Mutation.
What interventions are being tested in trial NCT06452277?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), BAY2927088 (DRUG).
Who is sponsoring clinical trial NCT06452277?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06452277 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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