Advanced non small cell lung cancer
Conditions
Interventions
CIMAvax-EGF therapeutic vaccine, 2.4 mg by intramuscular route.
Indication: induction stage, four weekly administrations every 14 days, maintenance stage, administration every 28 days until the patien
Immunotherapy, Active
Epidermal Growth Factor
Cyclophosphamide
Injections, Intramuscular
Administration, Intravenous
Sponsors
Center of Molecular Immunology (CIM)
Innovative Immunotherapy Alliance (IIA)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients of any sex and age greater than or equal to 18 years. 2. Patients who have signed the informed consent for the research. 3. Patients who meet the diagnostic criteria. 4. Patients with at least stable disease after 1st line chemotherapy, who have been included in clinical trials with the CIMAvax-EGF vaccine or have been treated as part of routine medical practice. 5. Patients who have completed the induction stage with the CIMAvax-EGF® vaccine and are receiving the vaccine as maintenance therapy. 6. Patients with clinical status criteria (ECOG) from 0 to 2
Exclusion criteria
Exclusion criteria: 1. Patients of childbearing potential who are not using adequate contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). In the case of males (vasectomy, use of condoms) while the treatment lasts 2. Pregnant, lactating or postpartum patients. 3. Patients with uncontrolled intercurrent illnesses including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus, arterial hypertension and psychiatric illnesses that imply the incompetence of the subject. 4. Patients with brain metastases. 5. Patients with acute allergic states or history of severe allergic reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, | — |
Countries
Cuba
Contacts
Public ContactGeidy Lorenzo Monteagudo
Center of Molecular Immunology
Outcome results
None listed