Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Small-Cell Lung Cancer Stage IIIB, Non-Small-Cell Lung Cancer Stage IV, Non-Small-Cell Lung Cancer Metastatic, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, Nonsmall Cell Lung Cancer

Intervention / Treatment
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* Biological: bavituximab
* Drug: Docetaxel
* Other: Placebo (for bavituximab)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bavituximab plus docetaxel<br>Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression. | Biological: bavituximab<br> <br> Drug: Docetaxel<br> <br> * Other names: Taxotere;|
| Placebo Comparator: placebo plus docetaxel<br>Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression. | Drug: Docetaxel<br> <br> * Other names: Taxotere;Other: Placebo (for bavituximab)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Approximately up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Approximately up to 36 months | 
| Overall Response Rate |  | Approximately up to 36 months | 
| Safety | As measured by adverse event rates and laboratory evaluations | Approximately up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SUNRISE, PPHM 1202, Bavituximab, Peregrine