Study of Osimertinib With and Without Ramucirumab in Advanced Non-Small Cell Lung Cancer
Sponsor: Xiuning Le
ClinicalTrials ID:NCT03909334
This clinical trial is testing whether adding the drug ramucirumab to osimertinib can improve outcomes for patients with advanced non-small cell lung cancer (NSCLC). The study will compare the effectiveness of the combination treatment against osimertinib alone in slowing down the progression of the disease.
Patient Parameters
| Parameter | Options |
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Program Overview
The main goal of this study is to see if combining two drugs, osimertinib and ramucirumab, is more effective than using osimertinib alone in treating advanced non-small cell lung cancer (NSCLC). Researchers will measure how long patients live without the cancer getting worse. A total of 150 patients will participate, with two-thirds receiving both drugs and one-third receiving only osimertinib. The study will consider factors like specific genetic mutations and whether the cancer has spread to the brain.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent and authorization to use personal health information.
- Must be 18 years or older.
- Must have a confirmed diagnosis of non-squamous, non-small cell lung cancer.
- Cancer must be advanced or has spread and cannot be treated with surgery or radiation.
- Must have specific genetic mutations in the EGFR gene.
- Must be in good general health with an ECOG performance status of 0 or 1.
- Must have measurable cancer according to specific criteria.
- If cancer has spread to the brain, it must be stable and not causing symptoms.
- Must be able to swallow pills.
- Previous chemotherapy or immunotherapy is allowed.
- Must have adequate blood, liver, and kidney function based on recent lab tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Men must agree to use contraception if sexually active with a woman of childbearing potential.
Exclusion Criteria
- Cannot take certain medications that affect heart rhythm or liver enzymes.
- Cannot have had another cancer in the past two years, except for certain skin cancers and other specific conditions.
- Cannot have been treated with certain cancer drugs before.
- Cannot have unresolved side effects from previous treatments.
- Cannot have uncontrolled health conditions, including high blood pressure or active infections.
- Cannot have severe nausea, vomiting, or digestive issues that prevent taking medication by mouth.
- Cannot have a history of lung disease or severe allergic reactions to study drugs.
- Cannot have certain heart conditions or recent heart-related events.
- Cannot have had significant bleeding or blood clots recently.
- Cannot have severe liver disease or recent major surgery.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Georgetown University | 20057 | Washington D.C. | District of Columbia |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Northwestern University Feinberg School of Medicine | 60611 | Chicago | Illinois |
| Rush University Medical Center | 60612 | Chicago | Illinois |
| Indiana Univesity Melvin and Bren Simon Cancer Center | 46202 | Indianapolis | Indiana |
| Summit Medical Group, PA | 07922 | Berkeley Heights | New Jersey |
| New York University Cancer Center | 10016 | New York | New York |
| Columbia University Irving Medical Center | 10032 | New York | New York |
| Providence Portland Medical Center | 97213 | Portland | Oregon |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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