This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
128
Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose
Adverse events
Time frame: Length of study
Changes in vital signs, physical findings, and clinical laboratory results during and following PRO95780 administration
Time frame: Length of study
Progression-free survival, as determined by independent review facility
Time frame: Length of study
Objective response and duration of response, as determined by independent review facility
Time frame: Length of study
Overall survival
Time frame: 24 months
Progression-free survival, objective response, and duration of objective response, as determined by the investigator
Time frame: Length of study
Pharmacokinetic parameters
Time frame: Length of study
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Intravenous repeating dose
Intravenous repeating dose