Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: Peregrine Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Bavituximab; Pemetrexed

Criteria

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