Non-Squamous Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC, lung cancer, non small cell lung cancer, bavituximab, monoclonal antibody
Brief summary
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).
Interventions
DRUGPaclitaxel / Carboplatin
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.
DRUGbavituximab
Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity.
Sponsors
Peregrine Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | Until disease progression |
Countries
Georgia, India, Russia, Ukraine, United States
Outcome results
None listed