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

UNC Lineberger Comprehensive Cancer Center

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer (NSCLC)

Treatments: Drug: Bavituximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01323062

LCCC 1030

Details and patient eligibility

About

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).

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Single-arm trial

Other group

Description:

Single-arm trial

Treatment:

Drug: Bavituximab