The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
255
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Solution, IV, AUC=6, Q21days, 6 cycles
Solution, IV, 2 mg/kg, Q7days, Until PD
Progression free survival based on tumor assessments (CT scans/MRI)
Time frame: every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC
Overall survival (OS) between 2 arms
Time frame: every 12 weeks
Objective tumor response rate (ORR) between 2 arms
Time frame: every 6 weeks
Safety in the CT-322 plus carboplatin and paclitaxel arm
Time frame: weekly
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Solution, IV, 15 mg/kg, Q21days, Until PD
Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Cancer Institute Of Florida
Orlando, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Clintell, Inc.
Skokie, Illinois, United States
Cancer Center Of Kansas
Wichita, Kansas, United States
Kentucky Cancer Clinic
Hazard, Kentucky, United States
Annapolis Oncology Center
Annapolis, Maryland, United States
Meritus Center For Clinical Research
Hagerstown, Maryland, United States
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo, Mississippi, United States
...and 45 more locations