The randomized Phase II clinical trial, under the direction of Dr. Mark Vincent as lead investigator at the London Regional Cancer Centre, will assess the safety and immunogenicity of the vaccine in stage III or IV patients with non small cell lung cancer. Lung cancer incidence is increasing, especially in women.
Surgery is currently the primary and most effective treatment for early disease.
The addition of radiotherapy and chemotherapy results is only marginally significant prolongation of survival. In patients with advanced non small cell lung cancer, stages IIIb or IV, who are unresponsive to therapy or refuse therapy, the median survival is approximately four months. Over expression of EGF-r may be associated with the continuing growth of cancer cells, metastatic spread and poor prognosis. In a further ongoing study in Cuba, involving advanced stage lung cancer patients not amenable to further standard treatment, the mean and median survival times in patients showing an immunogenic response are significantly longer than either historical controls or non-responders. Interim results had three patients surviving 18 months compared to the approximate four month expected median survival time.