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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2018-10-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-arm trial

Group Type OTHER

Bavituximab

Intervention Type DRUG

Administered 3 mg/kg weekly

Interventions

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Bavituximab

Administered 3 mg/kg weekly

Intervention Type DRUG

Other Intervention Names

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chimeric 3G4

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No