Non Small Cell Lung Cancer (NSCLC)
Conditions
Keywords
chemotherapy naive, stage IV non squamous non small cell lung cancer, Phase 1b, Bavituximab, Chimeric 3G4, U of North Carolina at Chapel Hill
Brief summary
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).
Detailed description
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.
Interventions
DRUGBavituximab
Administered 3 mg/kg weekly
Sponsors
Peregrine Pharmaceuticals
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than or equal to 18 * Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously treated with systemic chemotherapy * Evaluable disease by clinical or radiographic parameters * No history or concomitant malignancy * Adequate organ and marrow function * Female subjects with negative urine or serum pregnancy * ECOG must be 0 or 1
Exclusion criteria
* Squamous cell, small cell, or mixed histology * Known history of bleeding diathesis or coagulopathy * Cavitary tumors or tumors invading or abutting large blood vessels * Any history of thromboembolic events * Ongoing therapy with oral or parenteral anticoagulants * Major surgery within 4 weeks of Day 1 of treatment * Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease) * any history of significant vascular disease * Congestive heart failure * History of any condition requiring anti-platelet therapy * Serious non healing wound * Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis * Unable or unwilling to discontinue use of prohibited medications * D-dimers \>2 x ULN as measured on 2 separate occasions at least 1 day apart
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure number of severe side effects seen during first cycle of therapy | Three weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death | to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed |
Countries
United States
Outcome results
None listed