Study on Combining MLN4924, Carboplatin, and Paclitaxel for Advanced Non-Small Cell Lung Cancer After Immunotherapy
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03965689
This clinical trial is testing a new combination of drugs, including MLN4924, carboplatin, and paclitaxel, to see if they can better treat advanced non-small cell lung cancer (NSCLC) in patients who have already received immunotherapy.
Patient Parameters
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Program Overview
The purpose of this study is to find out if a combination of MLN4924 (also known as pevonedistat), carboplatin, and paclitaxel can effectively treat patients with advanced non-small cell lung cancer (NSCLC) who have previously been treated with immunotherapy. MLN4924 may help stop cancer cells from growing by blocking certain enzymes, while carboplatin and paclitaxel are chemotherapy drugs that work by killing cancer cells or stopping them from spreading. This study aims to see if this combination works better than standard chemotherapy treatments.
Description
The main goal of this study is to determine how well the combination of MLN4924, carboplatin, and paclitaxel works in treating advanced non-small cell lung cancer (NSCLC). Researchers will look at how many patients respond to the treatment, how long patients live without the cancer getting worse, and the overall survival rate. They will also evaluate the safety of this drug combination.
Patients will receive paclitaxel through an IV for 3 hours on the first day, carboplatin through an IV for 30-60 minutes on the first day, and MLN4924 through an IV for 1 hour on days 1, 3, and 5. This treatment cycle will repeat every 21 days for at least 4 cycles, as long as the cancer does not progress and side effects are manageable.
After finishing the treatment, patients whose cancer has not progressed will have follow-up visits 30 days later, every 3 months for the first year, and then every 6 months for up to 5 years.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of stage IIIB or IV non-small cell lung cancer (NSCLC) that is metastatic or cannot be removed by surgery.
- Have measurable cancer according to specific medical criteria.
- Have previously been treated with immunotherapy and have cancer that has progressed after treatment.
- Have adequate blood cell counts and organ function, including:
- Neutrophil count of at least 1,500/mcL.
- Platelet count of at least 150,000/mcL.
- Normal liver and kidney function as indicated by specific blood tests.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have a life expectancy of at least 12 weeks.
- Women of childbearing potential and men must agree to use effective contraception during the study and for 4 months after the last dose.
- Patients with controlled HIV, hepatitis B, or hepatitis C infections may be eligible if they meet specific criteria.
- Must be able to understand and sign a written informed consent document.
Exclusion Criteria
- Have not recovered from side effects of previous cancer treatments, except for hair loss and mild nerve damage.
- Are currently receiving other investigational drugs.
- Have a history of severe allergic reactions to similar drugs.
- Have had chemotherapy or radiation therapy within the last 2 weeks (or 6 weeks for certain drugs).
- Have uncontrolled medical conditions or psychiatric illnesses that would interfere with the study.
- Are pregnant or breastfeeding.
- Have severe heart or lung conditions, such as recent heart attack or severe lung disease.
- Have high blood pressure that is not controlled.
- Have had major surgery within the last 14 days or plan to have surgery during the study.
- Have life-threatening illnesses unrelated to cancer.
- Have severe liver disease or bleeding disorders.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Oncology/Hematology-Newport Beach | 92663 | Newport Beach | California |
| MedStar Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| Moffitt Cancer Center-International Plaza | 33607 | Tampa | Florida |
| Moffitt Cancer Center - McKinley Campus | 33612 | Tampa | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Rutgers Cancer Institute of New Jersey | 08903 | New Brunswick | New Jersey |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
| University of Wisconsin Carbone Cancer Center - University Hospital | 53792 | Madison | Wisconsin |
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