This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Hot Springs, Arkansas, United States
Unnamed facility
Santa Monica, California, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Port Saint Lucie, Florida, United States
Unnamed facility
Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST 1.1 criteria or death from any cause on study)
Time frame: Up to 24 months
Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1
Time frame: Up to 24 months
Duration of objective response (defined as the first occurrence of a documented objective response until the time of progression or death from any cause on study)
Time frame: Up to 24 months
Overall survival (defined as the time from randomization until death from any cause)
Time frame: Up to 24 months
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St. Petersburg, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Marietta, Georgia, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Wichita, Kansas, United States
...and 32 more locations