A Randomized Trial to Study the Safety and Efficacy of EGF Cancer Vaccination in Late-stage (IIIB/IV) Non-small Cell Lung Cancer Patients

Summary

The vaccine contains humanized recombinant antigen (Epithelial Growth Factor) and an adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation of tumour cell. A Phase III clinical trial on the EGF vaccine is ongoing in Cuba. The result from previous studies demonstrated positive correlation between extended survival and immune response against the vaccination in the late-stage NSCLC patients' age below 60 with improved quality of life. The purpose of this international Phase III trial is to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of stage IIIB/IV NSCLC patients compared to standard treatment and supportive care.

Timeline

Start

2011-11

Primary completion

2014-12

Completion

2014-12

Outcome

Outcome not reported

Stopped: “The early termination is not related to safety/toxicity but to initiate new Phase III with biomarker to enrich population \& to further strengthen OS benefit”

Drugs

Indications