SUNRISE trial

The SUNRISE trial is an international clinical trial studying non-small-cell lung carcinoma (NSCLC). The trial is ongoing and is sponsored by Peregrine Pharmaceuticals, Inc. It was started in December 2013 and is projected to end in December 2016.

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.^[1] Bavituximab has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of second-line non-small cell lung cancer (NSCLC).^[2]

Study design

Name

The full name of the trial is "Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer (SUNRISE)". Its ClinicalTrials.gov identifier is NCT01999673.

Purpose

SUNRISE ("Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study") is a Phase III, global, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and efficacy of bavituximab plus docetaxel in patients with second-line NSCLC. The trial will evaluate bavituximab plus docetaxel versus docetaxel plus placebo in approximately 600 patients at clinical sites worldwide. Patients with Stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrollment. Patients will be randomized into 1 of 2 treatment arms. All patients will receive up to six 21-day cycles of docetaxel (75 mg/m2) plus weekly infusions of either bavituximab (3mg/kg) or placebo until progression of toxicity. The primary endpoint of the trial will be overall survival.^[3]

In a Phase 2 clinical trial, in patients who mirror the entry criteria for the SUNRISE trial, the 3mg/kg bavituximab plus docetaxel arm resulted in a median overall survival of 11.7 months compared to 7.3 months in the control arm with the 3 mg/kg bavituximab plus docetaxel combination arm being well-tolerated with no significant differences in adverse events between the trial arms.^[4]

Study participants

The study is intended to enroll 582 people. Trial sites are open in Australia, Belgium, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Romania, Russian Federation, Spain, Taiwan, Ukraine and United States. As of March 31, 2015, there are 158 clinical trial sites open worldwide.^[5]

References