Study on Osimertinib With or Without Bevacizumab for Treating EGFR Positive Non-small Cell Lung Cancer with Brain Metastases
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02971501
This clinical trial is exploring how well the drug osimertinib, with or without bevacizumab, works in treating patients with a specific type of lung cancer that has spread to the brain. The study aims to see if these treatments can help control the cancer more effectively.
Patient Parameters
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Program Overview
This study is testing the effectiveness of osimertinib, a drug that may stop cancer cells from growing, with or without bevacizumab, which may slow cancer by blocking blood vessel growth. The trial focuses on patients with non-small cell lung cancer that has a specific mutation (EGFR positive) and has spread to the brain. Researchers want to find out if combining these drugs can better control the cancer compared to using osimertinib alone.
Description
The main goal of this study is to see how long patients can live without their cancer getting worse when treated with osimertinib and bevacizumab compared to osimertinib alone. Researchers will also look at the safety of these treatments and how well they work in controlling cancer in the brain.
Patients will be randomly assigned to one of two groups. One group will receive osimertinib daily and bevacizumab every three weeks. The other group will receive only osimertinib daily. Both groups will continue treatment as long as it is effective and side effects are manageable.
Throughout the study, patients will have regular scans and tests to monitor their cancer and overall health. After finishing the treatment, patients will be followed up for at least four weeks to check on their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Have non-small cell lung cancer with a specific EGFR mutation.
- Have not been treated with EGFR-targeting drugs before.
- Have at least one brain tumor that is not causing symptoms and does not need immediate treatment.
- Be 18 years or older.
- Be in good overall health with a performance status of 0 to 2.
- Have a life expectancy of more than 3 months.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test.
- Men must agree to use contraception during and after treatment.
- Be able to understand and sign a consent form.
Exclusion Criteria
- Have symptoms from brain tumors or need surgery for brain tumors.
- Have been treated with EGFR-targeting drugs or bevacizumab before.
- Need steroids for brain swelling or symptoms.
- Have other active cancers or serious health conditions.
- Have a history of severe allergic reactions to similar drugs.
- Have uncontrolled high blood pressure or heart problems.
- Have significant liver or kidney problems.
- Be unable to comply with study procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Keck Medical Center of USC Pasadena | 91105 | Pasadena | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Smilow Cancer Center/Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
| Moffitt Cancer Center-International Plaza | 33607 | Tampa | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| University of Kansas Clinical Research Center | 66205 | Fairway | Kansas |
| University of Kansas Hospital-Westwood Cancer Center | 66205 | Westwood | Kansas |
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