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

Non-Small-Cell Lung Cancer Stage IIIB research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

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

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:bavituximab

Drug:Docetaxel

Other:Placebo (for bavituximab)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

bavituximab plus docetaxelSix 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.

placebo plus docetaxelSix 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.

Study Status

Completed

Start Date: December 2013

Completed Date: March 2017

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Overall Survival

Secondary Outcome: Progression-free survival

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Peregrine Pharmaceuticals

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01999673

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