Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC

Official Title
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A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology

Conditions
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Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Carboplatin
* Drug: CT-322
* Drug: Bevacizumab
* Drug: Bevacizumab placebo (ie saline solution)


Participation Criteria
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Eligibility Criteria
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For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation. Inclusion Criteria: ECOG Performance Status (PS) <=1 Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC Measurable disease by RECIST guidelines Exclusion Criteria: Evidence of predominantly squamous-cell histology Known CNS metastases Any prior antineoplastic systemic regimens for NSCLC Excessive risk of bleeding (including use of therapeutic anticoagulation) and history of thrombotic or embolic cerebrovascular accident Gross hemoptysis (≥1/2 tsp of red blood) Uncontrolled hypertension Clinically significant cardiovascular disease History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paclitaxel/Carboplatin/CT-322<br> | Drug: Paclitaxel<br>* Solution, IV, 200 mg/m2, Q21days, 6 cycles<br>* Other names: Taxol;Drug: Carboplatin<br>* Solution, IV, AUC=6, Q21days, 6 cycles<br>* Other names: Paraplatin;Drug: CT-322<br>* Solution, IV, 2 mg/kg, Q7days, Until PD<br>* Other names: BMS-844203;|
| Active Comparator: Paclitaxel/Carboplatin/Bevacizumab/Placebo<br> | Drug: Paclitaxel<br>* Solution, IV, 200 mg/m2, Q21days, 6 cycles<br>* Other names: Taxol;Drug: Carboplatin<br>* Solution, IV, AUC=6, Q21days, 6 cycles<br>* Other names: Paraplatin;Drug: Bevacizumab<br>* Solution, IV, 15 mg/kg, Q21days, Until PD<br>* Other names: Avastin;Drug: Bevacizumab placebo (ie saline solution)<br>* Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD<br>* Other names: Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival based on tumor assessments (CT scans/MRI) |  | every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) between 2 arms |  | every 12 weeks | 
| Objective tumor response rate (ORR) between 2 arms |  | every 6 weeks | 
| Safety in the CT-322 plus carboplatin and paclitaxel arm |  | weekly |