Immunotherapy With Racotumomab Versus Support Treatment in Advanced Non-small Cell Lung Cancer Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

August 31, 2012

Study Completion Date

June 30, 2014

Conditions
Advanced Non-small Cell Lung Cancer
Interventions
BIOLOGICAL

racotumomab

Patients will receive best support treatment and vaccination with racotumomab. The vaccination schedule is as follows: 5 doses (1mg/mL each), subcutaneously, every 2 weeks (induction period) followed by monthly vaccinations until any criteria for discontinuation are met. If disease progression occurs and a second line therapy is indicated, the patient will only be able to continue in the study if the drug indicated is docetaxel. Vaccination will not be interrupted during docetaxel administration unless criteria for vaccine discontinuation are met.

OTHER

Best support treatment

Patients will receive best support treatment as indicated by the investigator. In case a second line therapy is indicated, docetaxel is the only drug allowed to continue in the study.

Trial Locations (1)

C1417DTB

"Instituto de Oncología Angel H. Roffo", Buenos Aires

Sponsors
All Listed Sponsors
lead

Laboratorio Elea Phoenix S.A.

INDUSTRY