Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects
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).
Checked against the public recordLast updated Dec 4, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Interventions being studied
- Drug: Bavituximab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 4, 2018. Always confirm current availability with the study team.