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
Overview
- Phase
- Phase 3
- Intervention
- bavituximab
- Conditions
- Non-Small-Cell Lung Cancer Stage IIIB
- Sponsor
- Peregrine Pharmaceuticals
- Enrollment
- 582
- Locations
- 1
- Primary Endpoint
- Overall Survival
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
bavituximab plus docetaxel
Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
Intervention: bavituximab
bavituximab plus docetaxel
Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
Intervention: Docetaxel
placebo plus docetaxel
Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
Intervention: Docetaxel
placebo plus docetaxel
Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
Intervention: Placebo (for bavituximab)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: Approximately up to 36 months
Secondary Outcomes
- Progression-free survival(Approximately up to 36 months)
- Overall Response Rate(Approximately up to 36 months)
- Safety(Approximately up to 36 months)