Clinical Trial Protocol Description:
The purpose of this study is to help us learn whether the study drug iza-bren (also known as Izalontamab Brengitecan) works in individuals with a certain type of lung cancer called non-small cell lung cancer (NSCLC) that has a specific change (mutation) in a gene called the epidermal growth factor receptor (EGFR, a protein that helps cells grow and divide) gene and their cancer has worsened after receiving treatment with medicines called EGFR tyrosine kinase inhibitors (TKIs). TKIs are drugs that block the action of EGFR to help stop cancer cells from growing.
Experts are still researching iza-bren to understand the side effects and how well it works. The study drug is not yet approved for lung cancer by health authorities, such as the U.S. Food and Drug Administration (FDA) or health authorities in other countries. This means that the study drug is investigational, which means that the drug is not approved by the FDA and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied.
If you agree to participate in this study, your participation may last for a maximum of about 5 years.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have at least one measurable lesion per response evaluation criteria in solid tumors.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Have a life expectancy of at least 3 months at the time of the first dose.
- Meet specified advanced/metastatic NSCLC subtype and biomarker eligibility requirements.
You will be excluded from the study if any of the following criteria apply to you:
- Have any mixed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) histology.
- Have known mutations in EGFR (Group A,B and E).
- Have a history of serious recurrent infections.
- Have a history of severe heart disease.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Study Details
Clinical Trial Investigator
Contact Information