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

Study Overview
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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).

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.

Official Title
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A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer

Conditions
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Non Small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Drug: Bavituximab


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-arm trial<br>Single-arm trial | Drug: Bavituximab<br>* Administered 3 mg/kg weekly<br>* Other names: chimeric 3G4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure number of severe side effects seen during first cycle of therapy | 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 | Three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed | At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy naive, stage IV non squamous non small cell lung cancer, Phase 1b, Bavituximab, Chimeric 3G4, U of North Carolina at Chapel Hill