Carcinoma, Non-Small-Cell Lung, Nonsmall Cell Lung Cancer, Non-Small Cell Lung Cancer, Non-Small-Cell Lung Cancer Metastatic, Non-Small-Cell Lung Cancer Stage IIIB, Non-Small-Cell Lung Cancer Stage IV, Non-Small-Cell Lung Carcinoma
Conditions
Keywords
SUNRISE, PPHM 1202, Bavituximab, Peregrine
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
BIOLOGICALbavituximab
DRUGDocetaxel
OTHERPlacebo (for bavituximab)
Sponsors
Peregrine Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female at least 18 years of age * Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition) * Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic, renal and hepatic function
Exclusion criteria
* Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC * Known history of bleeding disorders, eg, von Willebrand disease or hemophilia * Cavitary tumors or tumors invading or abutting large blood vessels * Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening * Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening * Grade 2 or higher peripheral neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | Approximately up to 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Approximately up to 36 months | — |
| Overall Response Rate | Approximately up to 36 months | — |
| Safety | Approximately up to 36 months | As measured by adverse event rates and laboratory evaluations |
Countries
Australia, Belgium, France, Germany, Greece, Hungary, Italy, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United States
Outcome results
None listed