This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).
Subjects with measurable disease will be assessed for response after every 2 cycles of therapy using RECIST 1.1 criteria. In addition, progression free survival (PFS), overall survival (OS) and exploratory biomarkers, imaging, and thrombotic risk parameters will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Administered 3 mg/kg weekly
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Measure number of severe side effects seen during first cycle of therapy
To determine the maximum tolerated dose based on occurrence of dose-limititing toxicity (DLT) within the first 3 weeks of treatment to determine appropriate and safe dose of bavituximab in combination with carboplatin and pemetrexed
Time frame: Three weeks
Progression free survival
to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed
Time frame: At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death
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