A Phase 1 interventional study of Bavituximab in Non Small Cell Lung Cancer (NSCLC), sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-04.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 1, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single-arm trial
Drug: Bavituximab
Administered 3 mg/kg weekly
Also known as: chimeric 3G4
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
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center