Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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The primary objective of this study is to determine the overall response rate (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small cell lung cancer.

Official Title
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A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: bavituximab plus paclitaxel and carboplatin


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Adults over age 18 years of age with a life expectancy of at least 3 months Histologically or cytologically confirmed non-small cell lung cancer at stage IIIB (with pleural effusion), stage IV, or recurrence Measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral CT) Adequate hematologic (ANC ≥ 1500 cells/µL; Hemoglobin ≥9 g/dL; platelets ≥100,000/µL and ≤500,000/µL ), renal (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min), and hepatic function (bilirubin ≤ 1.5 x ULN, ALT ≤ 3 x ULN, AST ≤ 3 x ULN) D-dimer ≤ 2 x ULN Key Exclusion Criteria: Small cell or mixed histology Known history of bleeding diathesis or coagulopathy Any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or GI bleeding Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy Radiotherapy within 2 weeks preceding Study Day 1 Symptomatic or clinically active CNS disease or metastatic lesions Major surgery within 4 weeks of Study Day 1 Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease) Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin. Anti-platelet agents are prohibited during the study. Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs, or steroids

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

| Intervention/Treatment |
| --- |
|Drug: bavituximab plus paclitaxel and carboplatin|Weekly bavituximab dose of 3 mg/kg until disease progression, and up to 6 cycles of carboplatin at a dose of AUC=5 and paclitaxel 175 mg/m2 every 21 days (21-day cycles)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small-cell lung cancer |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tumor progression, duration of response, overall survival and safety |  | Approximately 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC