Advanced non small cell lung cancer
Conditions
Interventions
CIMAvax-EGF group (Experimental): CIMAvax-EGF therapeutic vaccine, 2.4mg by intramuscular route. It will administer in induction and maintenance stage
Induction stage: Four weekly administrations ever
Immunotherapy, Active
Epidermal Growth Factor
Cyclophosphamide
Injections, Intramuscular
Administration, Intravenous
Sponsors
Center of Molecular Immunology
Innovative Immunotherapy Alliance (IIA)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who have signed the informed consent for the research. 2. Patients of any sex and age, greater than or equal to 18 years. 3. Patients who meet the diagnostic criteria. 4. Patients with available paraffin tissue block. 5. Patients with clinical status criteria (ECOG) from 0 to 2. 6. Patients who have achieved a response (complete or partial) or stable disease (not progressive) after the first line of cancer-specific treatment. 7. Patients with a life expectancy of 6 months or more.
Exclusion criteria
Exclusion criteria: 1. Patients of childbearing potential who are not using an adequate method of 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 who are participating in another clinical trial or who have been treated with specific immunotherapy with CIMAvax-EGF in the previous 6 months. 4. 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. 5. Patients with acute allergic states or history of severe allergic reactions. 6. Patients with brain metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. EGFR, KRAS, BRAF mutations and ALK, ROS1 and PD-L1 expression in paraffin biopsies ((EGF, KRAS, BRAF determined by Molecular Biology ; ALK, ROS1 y PD-L1 by Immunohistochemistry). Measurement time: At diagnosis of the disease 2. EGFR, KRAS, BRAF mutations in liquid biopsies (cfDNA) (determined by Molecular Biology). Measurement time: At diagnosis of the disease, day o and 6, 24 and, 36 months. 3. EGF gene polymorphism (Allele specific RT PCR technology). Measurement time: Before administration of cyclophosphamide (Day 0) 4. Genetic profile of the nasal epithelium (micorarray technology). Measurement time: At diagnosis of the disease, day 0, and 6, 24 and, 36 months. 5. Evaluation of cytokines and EGFR growth factors (concentrations of EGF, TGF alpha, IL8, IL4, IL-13 and other cytokines as well as antibodies vs EGF). Measurement time: Before administration of cyclophosphamide (Day 0) and the months 3 (5th immunization), 6, 12, 15, 18, 24, 30 and, 36. 6. EGF concentration and Antibody response vs EGF. (Ab concentrations vs EGF) Measurement time: Before administration of cyclophosphamide (Day 0) and the months 3 (5th immunization), 6, 12, 15, 18, 24, 30 and, 36. 7. Lymphocyte subpopulations in peripheral blood mononuclear cells (PBMC): (concentrations of naive T CD8 cells, effector T CD8 cells, naive T CD4 cells, effector T CD4 cells, Th17 cells, T regs cells, B CD19 + cells, T CD4 + cells, T CD8 + cells, T CD8 + CD28- cells, CD4 / CD8 index, other cells). Measurement time: Before administration of cyclophosphamide (Day 0) and 6, 12, 18, 24, 30 and, 36 months. 8. Overall survival (Time from the recruitment date until to the date of death. In case of not being certain of the death of the patient, the time elapsed until the date on which the latest news of the patient is recorded in the clinical history will be collected). Measurement time: From recruitment until death or last contact 9. Progression-free survival (Time from the recruitment date until to the date of dis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response: measured through imaging tests: Tomography, X ray, ultrasound. The response evaluation corresponding to the follow-up with the CIMAvax-EGF vaccine will be carried out taking into account the iRECIST and will be classified as: iCR (immune Complete response), iPR (immune Partial response), iSD (immune Stable disease), iCPD (immune confirmed progression) and iUPD (immune unconfirmed progression). Measurement time: after starting CIMAvax-EGF treatment and every 3 months, for a period of 3 years measured from the inclusion of the patient in the trial. 2. Toxicity. Evaluated through the appearance of adverse events Measurement time: from the start of treatment with CIMAvax-EGF and for a period of 3 years. | — |
Countries
Cuba
Contacts
Public ContactGeidy Lorenzo Monteagudo
Center of Molecular Immunology
Outcome results
None listed