NCT01240447

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

A Prospective, Randomised, Open Label Phase II Study of Active Specific Immunotherapy With Racotumomab Versus Support Treatment in Patients With Advanced Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Laboratorio Elea Phoenix S.A. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate safety and immunogenicity of racotumomab in patients with advanced Non-small Cell Lung Cancer (NSCLC), in concomitance with chemotherapy (docetaxel) when a second-line therapy is indicated. The study will also compare survival and progression free survival on both study arms.

Conditions

• Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-08-01
• Completion: 2014-06-01
• First posted: 2010-11-15
• Last updated: 2014-07-10

Locations

1 site across 1 country: Argentina