Non Small Cell Lung Cancer Clinical Trial
Official title:
A Phase 1b Study of Carboplatin and Pemetrexed Plus Demcizumab (OMP-21M18) as 1st-line Treatment in Subjects With Non-Squamous Non-Small Cell Lung Cancer
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.
Current cancer therapies often produce an initial reduction in tumour size but may not have
longterm benefits. One possible explanation for this is the presence of cancer cells known as
cancer stem cells. Cancer stem cells represent a small part of the tumour but are believed to
be responsible for much of the growth and spread of the cancer. They may also be more
resistant to traditional therapy, such as chemotherapy and radiation therapy.
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.
In addition to routine testing of blood and urine (for complete blood counts with
differential and platelets, coagulation studies to determine how quickly your blood is
clotting; serum chemistries; B-type natriuretic peptide [BNP] and Troponin I, which indicate
how well your heart if working; creatinine clearance to measure your kidney function and
urinalysis), special tests will be performed during the study at specific time points.
In addition, you will have an ECG and doppler echocardiogram performed during screening, then
every 28 days on study and at treatment termination. Your Doppler echocardiograms may be sent
to a Cardiologist at another hospital who may perform a central read on some of the doppler
echocardiograms in this study. Finally, you will have a head CT or MRI at baseline and CT
scans and/or other radiographs performed every 56 days to assess the status of your tumor.
The study includes an optional part which will investigate how variations in people's genetic
makeup affect their response to medications. This involves the collection of one blood sample
just before participants receive their first dose of study treatment. DNA will be extracted
from the blood sample for testing.
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