A Study of Carboplatin and Pemetrexed Plus Demcizumab (OMP-21M18) in Subjects With Non-Squamous Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test the safety and determine the optimal dose of a new drug,
demcizumab (OMP-21M18), when given in combination with carboplatin and pemetrexed, a standard
drug treatment regimen for non-squamous non-small cell lung cancer (NSCLC). Participants must
not have received prior chemotherapy for their NSCLC. Demcizumab is a humanized monoclonal
antibody (a protein made in the laboratory) developed to target cancer stem cells. The way
the body handles demcizumab will also be investigated.
Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain.
Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your
eligibility to take part in this study, and then if enrolled in the study you will receive
intravenous (in the vein) infusions of the demcizumab, carboplatin, and pemetrexed
administered on the same day, every 21 days for 4 cycles, or until it has been shown that
your cancer has progressed. If your physician decides to delay treatment with one of the
agents due to side effects, the other agents may still be administered as scheduled. After 4
cycles, if you have stable or improved disease, you will continue to receive pemetrexed once
every 21 days as maintenance therapy. You will undergo assessments every 8 weeks to determine
the status of your disease.