Official websites use. Share sensitive information only on official, secure websites. This article is published under license to BioMed Central Ltd. The trial will assess the safety and tolerability of CV vaccination combined with local radiation designed to enhance immune responses and will include patients with stage IV NSCLC and a response or stable disease after first-line chemotherapy or therapy with an EGFR tyrosine kinase inhibitor.
All patients will receive two initial vaccinations with CV prior to local radiotherapy 5 GY per day for four successive days followed by further vaccinations until disease progression. Pharmacodynamic analyses include the assessment of immune responses to the antigens encoded by CV and others not included in the panel antigen spreading and standard efficacy assessments.
RNActive self-adjuvanted mRNA vaccines offer the potential for simultaneously inducing immune responses to a wide panel of antigens commonly expressed in tumors.
This trial will assess the feasibility of this approach in combination with local radiotherapy in NSCLC patients. Lung cancer is the leading cause of cancer-related mortality in both men and women and the incidence of the disease is increasing globally [ 1 ]. These patients have a particularly poor prognosis and represent a significant unmet medical need.
The selection of appropriate therapy is determined by the histological and molecular subtype of the disease. Four to six cycles of a non-pemetrexed-containing platinum-based combination chemotherapy is the recommended first-line therapy for fit patients with squamous cell histology, whereas in patients with non-squamous cell histology, a chemotherapy combination of pemetrexed and a platinum-based chemotherapy is a well-accepted standard of care [ 3 ].
