Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
1-Expression of biomarkers in paraffin biopsies or cytology (EGFR mutations, KRAS mutations, BRAF mutations by molecular biology) and (ALK, ROS1 and PD-L1 expression by immunohistochemistry). Measurement time: At diagnosis of the disease
2-EGFR mutations in liquid biopsies (KRAS and BRAF mutations by molecular biology (cfDNA)). Measurement time: during the maintenance phase with CIMAvax-EGF, every 6 months or 1 year after the previous extraction; for a period of 2 years.
3-Genetic profile of the nasal epithelium by brushing (Genetic Profile). Measurement time: during the maintenance phase with CIMAvax-EGF, every 6 months or 1 year after the previous extraction; for a period of 2 years.
4-EGFR cytosine and growth factor concentration (EGF concentration, TGF alpha concentration, IL8 concentration, IL4 concentration, IL 13 concentration, other cytosine concentration) Measurement time: during the maintenance phase with CIMAvax-EGF, every 6 months or 1 year after the previous extraction; for a period of 2 years.
5- Antibody response vs EGF (Titer of Ab Anti EGF). Measurement time: during the maintenance phase with CIMAvax-EGF, every 6 months or 1 year after the previous extraction; for a period of 2 years.
6- Percentage of lymphocyte subpopulations in circulating peripheral mononuclear cells (PBMC). (% CD8 naive T,% CD8 effector cells,% CD4 naive T cells,% CD4 effector T cells,% th17 T cells,% Tregs cells,% CD19 + B cells,% CD4 + T cells,% CD8 + T cells,% CD8 + CD28 T cells -, CD4/CD8 index) Measurement time: during the maintenance phase with CIMAvax-EGF, every 6 months or 1 year after the previous extraction; for a period of 2 years.
7- Global survival time (Time between the begining of CIMAvax-EGF treatment and the date of death of the patient or date of last news). Measurement time: At baseline and, monthly for 2 years.
8-Treatment evaluation for progression (Complete Response, Partial Response, Stable Disease, Progression Disease): Measurement time: at baseline and, every 6 months for 2 years.