Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452277
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-05
Brief Title:
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 in the Genes of Human Epidermal Growth Factor Receptor 2 HER2
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOHO-02
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-511319-91-00 | OTHER | CTIS EU | None |