Study on Ramucirumab and Erlotinib for Untreated Patients with EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Eli Lilly and Company
ClinicalTrials ID:NCT02411448
This clinical trial is testing the effectiveness and safety of combining the drugs ramucirumab and erlotinib compared to a placebo with erlotinib in patients with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations. The study also explores the combination of ramucirumab with other drugs in certain patient groups.
Patient Parameters
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Program Overview
The study aims to evaluate how well the combination of ramucirumab and erlotinib works in treating patients with stage IV non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene. It will compare this combination to a placebo with erlotinib. The study will also look at the safety of these treatments. In a specific part of the study, the effectiveness of ramucirumab with gefitinib will be tested in East Asian patients, and for those whose cancer progresses, the combination of ramucirumab with osimertinib will be evaluated.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage IV non-small cell lung cancer (NSCLC) based on specific medical criteria.
- Eligible for first-time treatment with erlotinib due to specific EGFR gene mutations in the cancer.
- Able to provide a sample of cancer tissue for testing.
- Have at least one tumor that can be measured by scans.
- Expected to live for at least 3 more months.
Exclusion Criteria
- Have a specific EGFR mutation known as T790M (except for certain parts of the study).
- Have cancer that has spread to the brain or spinal cord and is not controlled.
- Have serious illnesses or medical conditions.
- Currently taking certain medications that affect liver enzymes or nonsteroidal anti-inflammatory drugs for a long time.
- Have a history of coughing up blood or significant bleeding disorders.
- Have cancer that has invaded major blood vessels or has cavities within the tumor.
- Have had a hole in the gastrointestinal tract or bowel obstruction recently.
- Have had a blood clot in an artery within the last 6 months.
- Have significant eye surface problems.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA Hematology/Oncology - Santa Monica | 90404 | Los Angeles | California |
| St. Charles Health System | 80203 | Denver | Colorado |
| The Gastroenterology Group, P.C. | 96813 | Honolulu | Hawaii |
| Cancer Center of Kansas | 67214 | Wichita | Kansas |
| Queens Medical Associates | 11366 | Fresh Meadows | New York |
| Levine Cancer Institute | 28204 | Charlotte | North Carolina |
| AHN Allegheny General Hospital | 15212 | Pittsburgh | Pennsylvania |
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