Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer

Study Overview
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Brief Summary
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This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).

Official Title
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A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

Conditions
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Non-Squamous Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Paclitaxel / Carboplatin
* Drug: bavituximab


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Adults over 18 years of age with a life expectancy of at least 3 months. Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1). Adequate hematologic, renal and hepatic function. PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN. Key Exclusion Criteria: Squamous cell, small cell, or mixed histology. Known history of bleeding diathesis or coagulopathy. Cavitary tumors or tumors abutting large blood vessels. Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening. Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of Screening. Ongoing therapy with oral or parenteral anticoagulants. Concurrent estrogens, anti-estrogens or progesterone compounds. Grade 2 or higher peripheral neuropathy. Radiotherapy within 2 weeks preceding Study Day 1. Symptomatic or clinically active brain metastases. Major surgery within 4 weeks of Study Day 1. Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease). Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of Screening.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paclitaxel/carboplatin plus bavituximab<br>Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly. | Drug: Paclitaxel / Carboplatin<br>* Patients will receive commercially available paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles.<br>Drug: bavituximab<br>* Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity.<br>|
| Active Comparator: paclitaxel/carboplatin<br>Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles. | Drug: Paclitaxel / Carboplatin<br>* Patients will receive commercially available paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | Until disease progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, lung cancer, non small cell lung cancer, bavituximab, monoclonal antibody