Currently there are no predictive biomarkers that could guide the use of anti-angiogenic therapies in patients with non-small cell lung cancer (NSCLC) with adenocarcinoma tumor histology. Therefore, the European Medicines Agency (EMA) requested the sponsor to develop this project.
The objective of this Non Interventional Study is to examine whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict overall survival in NSCLC patients eligible for treatment with Vargatef®. The investigations in this study are exploratory in nature and considered to be hypothesis generating. The results from these investigations may help to expand knowledge of the disease and the response to Vargatef®. The results of this project could guide physicians in the use of anti-angiogenic therapies.
The study targets patients with non-small cell lung cancer (NSCLC) with adenocarcinoma tumor histology, which are eligible to be treated with Vargatef ® according to the approved indication. The first patient in Belgium was included in September 2016.
Luxembourg participates with one site (Centre Hospitalier de Luxembourg (CHL)). CIEC-LIH supports the physician participating in this study. Globally, it is planned to enroll 300 patients and approximately 3 patients in Luxembourg.
www.luxclin.lu/Studies/Details/?c=STP8188TAY
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