US-based clinical stage biopharmaceutical company Peregrine Pharmaceuticals has started the patient enrolment in its SUNRISE trial, a pivotal Phase III study designed to evaluate the safety, tolerability and efficacy of bavituximab plus docetaxel in patients with second-line non-small cell lung cancer (NSCLC).
SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) will evaluate bavituximab plus docetaxel versus docetaxel plus placebo in approximately 600 patients at more than 100 clinical sites worldwide.
SUNRISE, a global, randomised, double-blind, placebo-controlled clinical study, will enrol patients at leading oncology centres in the US.
Patients with Stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrolment and will be randomised into 1 of 2 treatment arms.
All patients will receive up to six 21-day cycles of docetaxel (75mg/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.
According to the company, the design of the SUNRISE trial was based on the compelling Phase II data that demonstrated encouraging improvement in overall survival in patients with second-line NSCLC.
Furthermore, peer-reviewed published data supported that bavituximab and docetaxel share highly compatible mechanisms of action that hold promise for improved patient outcomes.
Peregrine CEO Steven King said: "As part of our plan to provide patient and physicians with the necessary information regarding this trial, today we launched the SunriseTrial.com web portal to serve as a gateway for trial parameters and additional resources.
"We anticipate that in executing our global plan we can enrol the majority of patients in this trial from the United States and Western Europe."