This trial has been completed.

Conditions 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
Treatments bavituximab, docetaxel, placebo (for bavituximab)
Phase phase 3
Target phosphotidylserine
Sponsor Peregrine Pharmaceuticals
Start date December 2013
End date March 2017
Trial size 582 participants
Trial identifier NCT01999673, 2013-003953-13, PPHM 1202


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, investigator
Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
docetaxel Taxotere
(Placebo Comparator)
Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
docetaxel Taxotere
placebo (for bavituximab)

Primary Outcomes

Overall Survival
time frame: Approximately up to 36 months

Secondary Outcomes

Progression-free survival
time frame: Approximately up to 36 months
Overall Response Rate
time frame: Approximately up to 36 months
time frame: Approximately up to 36 months

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Peregrine Pharmaceuticals.