Non-small-cell Lung Cancer
Conditions
Keywords
NSCLC, second-line, lung cancer, non small cell lung cancer, bavituximab, monoclonal antibody
Brief summary
The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.
Interventions
DRUGDocetaxel plus bavituximab or placebo
Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.
Sponsors
Peregrine Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over age 18 years of age with a life expectancy of at least 3 months. * Histologically or cytologically confirmed stage IIIB or stage IV non squamous non-small-cell lung cancer (NSCLC) who have progressed after 1 chemotherapy regimen. * Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.1) on cross-sectional imaging that is at least 2 cm in longest diameter. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2. * Adequate hematologic, renal, and hepatic function. * PT/INR ≤ 1.5 × ULN; aPTT time ≤ 1.5 × ULN. * New York Heart Association classification I or II
Exclusion criteria
* Squamous, small cell, or mixed histology. * Known history of bleeding diathesis or coagulopathy. * Cavitary tumors or tumors invading or abutting large blood vessels. * Bleeding: Clinically significant bleeding such as gross hematuria, GI bleeding and hemoptysis within 12 months of Screening. * Venous thromboembolic events within 6 months of screening. * Ongoing therapy with oral or parenteral anticoagulants. * Concurrent estrogens, anti-estrogens or progesterone compounds. * Radiotherapy within 2 weeks or major surgery within 4 weeks preceding Study Day 1. * Symptomatic or clinically active brain metastases. * Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris within 6 months of screening. * Grade 2 or higher peripheral neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | Until disease progression |
Countries
Georgia, India, Russia, Ukraine, United States
Outcome results
None listed