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

Peregrine Pharmaceuticals

Status and phase: Completed; Phase 3

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

Treatments: Drug: Docetaxel; Biological: bavituximab; Other: Placebo (for bavituximab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01999673

PPHM 1202

2013-003953-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 582 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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582 participants in 2 patient groups, including a placebo group

bavituximab plus docetaxel

Experimental group

Description:

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

Treatment:

Biological: bavituximab

Drug: Docetaxel

placebo plus docetaxel

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo (for bavituximab)

Drug: Docetaxel