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

Phase 3

Completed

• Conditions: Non-Small-Cell Lung Cancer Metastatic; Non-Small-Cell Lung Carcinoma; Non-Small Cell Lung Cancer; Non-Small-Cell Lung Cancer Stage IIIB; Non-Small-Cell Lung Cancer Stage IV; Carcinoma, Non-Small-Cell Lung; Nonsmall Cell Lung Cancer
• Interventions: Biological: bavituximab; Other: Placebo (for bavituximab); Drug: Docetaxel

• Registration Number: NCT01999673
• Lead Sponsor: Peregrine Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-11-25
• Study Start: 2013-12
• Study First Posted: 2013-12-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bavituximab plus docetaxel	bavituximab	Six 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 docetaxel	Placebo (for bavituximab)	Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
bavituximab plus docetaxel	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.
placebo plus docetaxel	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival	Approximately up to 36 months

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Approximately up to 36 months
Overall Response Rate	Approximately up to 36 months
Safety	Approximately up to 36 months	As measured by adverse event rates and laboratory evaluations

Trial Locations

Locations (1)

Peregrine Pharmaceuticals Investigational Site; 🇺🇦 Uzhgorod, Ukraine