UCSD Study Contact:
Clinical Research Coordinator Kelly Souder at 858/822-7952 or knsouder@ucsd.edu.  

Introduction:
Moores Cancer Center is a major site in the U.S. for this trial and the first institution to recruit a patient. The vaccine consists of genetically engineered lung cancer cells that are injected into the patient's arm on a monthly basis. The purpose of the therapy is to retrain the patient's immune system to recognize and kill the cancer cells. Results obtained from earlier phase I/II clinical trials of the Lucanix vaccine determined that survival of patients was double at 2 years, a positive outcome not previously seen in patients with advanced lung cancer.

Official Title:
Phase III Prospective, Randomized, Double-blind, Registration Study of (belagenpumatucel-L) vs. Best Supportive Care as Frontline, Adjuvant Therapy for Stages III/IV Non-small Cell Lung Cancer (Protocol No: NR001-03)

Purpose of the Trial:
To determine if Lucanix improves survival of lung cancer patients. Seven hundred patients are expected to enroll internationally.  

Patient Profile:
Male or female patients, between age 18 and 75 years, with stage IIIA, IIIB, and IV non-small-cell lung cancer who have completed platinum based chemotherapy but did not progress on it.

Treatment Pattern:

• To receive 4 to 6 cycles of platinum bases doublet, with or without addition of bevacizumab.  
• The patient is then given a break and chemotherapy restarted once the cancer starts to grow back.
• During this break, study participants will receive Lucanix (Belagenpumatucel-L) or placebo.

Principal Investigator / Physician Profile:
Lyudmila Bazhenova, M.D.
Assistant Clinical Professor of Medicine
http://cancer.ucsd.edu/Research/Summaries/lbazhenova.asp
“There have been no significant improvements in therapies for advanced non small cell lung cancer over the past 2 to 3 decades, “ says Lyudmila Bazhenova, M.D. assistant clinical professor of medicine and the trial's principal investigator. “We are hoping that the Lucanix vaccine lives to its expectations and improves survival for patients with advanced lung cancer.”  

Details for Health Care Professionals: http://cancer.ucsd.edu/PatientCare/ClinicalTrials/study_details.asp?P=NR001-03

Other U.S. Locations:
http://clinicaltrials.gov/ct2/show/NCT00676507?term=lucanix&rank=1

Manufacturer:
NovaRX