Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2013 |
SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Previously Treated Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer
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.
investigational drug) to the standard chemotherapy drug docetaxel, will improve the results
of the treatment for non-small-cell lung cancer.
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
We found this trial at
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