Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage 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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 21, 2017 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Peregrine Pharmaceuticals
- Interventions being studied
- Biological: bavituximab; Drug: Docetaxel; Other: Placebo (for bavituximab)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Peregrine Pharmaceuticals Investigational SiteHuntsville, Alabama
- Peregrine Pharmaceuticals Investigational SiteChandler, Arizona
- Peregrine Pharmaceuticals Investigational SiteGlendale, Arizona
- Peregrine Pharmaceuticals Investigational SiteGreenbrae, California
- Peregrine Pharmaceuticals Investigational SiteLos Angeles, California
- Peregrine Pharmaceuticals Investigational SiteOceanside, California
- Peregrine Pharmaceuticals Investigational SiteOrange, California
- Peregrine Pharmaceuticals Investigational SiteWest Hills, California
- Peregrine Pharmaceuticals Investigational SiteFort Myers, Florida
- Peregrine Pharmaceuticals Investigational SiteSt. Petersburg, Florida
- Peregrine Pharmaceuticals Investigational SiteTampa, Florida
- Peregrine Pharmaceuticals Investigational SiteAthens, Georgia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 21, 2017. Always confirm current availability with the study team.