CIMAvaxEGF in Non Small Cell Lung Cancer. Exploratory Study of Biomarkers

Evaluation of biomarkers associated with the clinical effect of the CIMAvax-EGF® vaccine in patients with advanced stages of non-small cell lung cancer (NSCLC). Exploratory Study of Biomarkers - EMA-Lung

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

RPCEC

Registry ID

RPCEC00000445

Enrollment

Registered

2024-06-20

Start date

2024-07-01

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Interventions

Group CIMAvax-EGF® vaccine (experimental): A dose (2.4 mg) of the vaccine will be administered intramuscularly in an induction stage and a maintenance stage. In the induction stage, a dose will be adm

Eligibility

Sex/Gender

All

Age

19 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 older than 19 years. 3. Patients who meet the diagnostic criteria. 4. Patients with clinical status criteria (ECOG) of 0 a2. 5. Patients who have achieved partial response or stable disease after the first line of onco-specific treatment. 6. 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 the male sex (vasectomy, use of condoms) while the treatment lasts 2. Pregnant, breastfeeding 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 diseases that include, but are not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus, arterial hypertension and psychiatric diseases that imply the incompetence of the subject. 5. Patients with acute allergic states or history of severe allergic reactions. 6. Patients with brain metastasis.

Design outcomes

Primary

Measure	Time frame
1- Activation of EGFR, cell proliferation, apoptosis and angiogenesis (in tumor biopsy measured by multiparametric immunofluorescence staining techniques). Measurement time: At baseline, 6 months and 24 months. 2- Cellular inflammatory infiltrate (measurement of CD3, CD8, Treg and B lymphocytes, myeloid suppressor cells (MDSC and/or DC), macrophages (M1/M2), as well as PD expression measured by multiparametric immunofluorescence staining techniques). Measurement time: At baseline, 6 months and, 24 months 3- EGFR, KRAS mutations and EGF gene polymorphism (measurement by liquid biopsy). Measurement time: At baseline 4- Cytokines and EGFR growth factors (concentrations of EGF, TGF alpha, IL-6, IL8, CCL20, CXCL5, CCL2, CCL4, CCL5, CXCL9, CXCL10 through Luminex technology using ELISAS kit. In the case of EGF in serum will be measured through a commercial ELISA system). Measurement time: 6 and 24 months. 5- Genetic characteristics of the bronchial epithelium (will be evaluated by nasal brushing). Measurement time: At baseline, 6 months and 24 months 6- EGF concentration and antibody response vs EGF. (Ab vs EGF concentrations by means of an ELISA assay). Measurement time: At baseline, 6 months and 24 months 7- Lymphocyte subpopulations in circulating peripheral mononuclear cells (PBMC): (quantification of naïve CD8 T cells, effector CD8 T cells, naïve CD4 T cells, effector T CD4, Th17 cells, T regs cells, CD19+ B cells, CD4+ T cells, CD8+ T, CD8+ CD28- T cells, CD4/CD8 ratio, other cells will be purified with Ficoll-Paque PLUS reagent (AmershamBiosciences), by density gradient after centrifugation). Measurement time: At baseline, 6 months and 24 months 8- Overall survival (the time from the date of inclusion in the study until the date of death. If there is no certainty of the patient's death, the time elapsed until the date on which the latest news about the patient is recorded in the clinical history will be recorded). Measurement time: 24 months 9- Progression-Free surv	—

Measure

Time frame

1- Activation of EGFR, cell proliferation, apoptosis and angiogenesis (in tumor biopsy measured by multiparametric immunofluorescence staining techniques). Measurement time: At baseline, 6 months and 24 months. 2- Cellular inflammatory infiltrate (measurement of CD3, CD8, Treg and B lymphocytes, myeloid suppressor cells (MDSC and/or DC), macrophages (M1/M2), as well as PD expression measured by multiparametric immunofluorescence staining techniques). Measurement time: At baseline, 6 months and, 24 months 3- EGFR, KRAS mutations and EGF gene polymorphism (measurement by liquid biopsy). Measurement time: At baseline 4- Cytokines and EGFR growth factors (concentrations of EGF, TGF alpha, IL-6, IL8, CCL20, CXCL5, CCL2, CCL4, CCL5, CXCL9, CXCL10 through Luminex technology using ELISAS kit. In the case of EGF in serum will be measured through a commercial ELISA system). Measurement time: 6 and 24 months. 5- Genetic characteristics of the bronchial epithelium (will be evaluated by nasal brushing). Measurement time: At baseline, 6 months and 24 months 6- EGF concentration and antibody response vs EGF. (Ab vs EGF concentrations by means of an ELISA assay). Measurement time: At baseline, 6 months and 24 months 7- Lymphocyte subpopulations in circulating peripheral mononuclear cells (PBMC): (quantification of naïve CD8 T cells, effector CD8 T cells, naïve CD4 T cells, effector T CD4, Th17 cells, T regs cells, CD19+ B cells, CD4+ T cells, CD8+ T, CD8+ CD28- T cells, CD4/CD8 ratio, other cells will be purified with Ficoll-Paque PLUS reagent (AmershamBiosciences), by density gradient after centrifugation). Measurement time: At baseline, 6 months and 24 months 8- Overall survival (the time from the date of inclusion in the study until the date of death. If there is no certainty of the patient's death, the time elapsed until the date on which the latest news about the patient is recorded in the clinical history will be recorded). Measurement time: 24 months 9- Progression-Free surv

—

Secondary

Measure	Time frame
1. Objective response (Performed using RECIST criteria and classified as Complete response, Partial response, Stable disease or Disease progression). Measurement time: At baseline and, every 3 months during 24 months 2. Adverse Events- AE (It will be measured taking into account Type of AE (Dermatological system disease, Gastrointestinal system disease, Respiratory system disease, general, and others), Duration of the AE (time from start AE until finish AE), AE intensity (Grade 1 or mild, Grade 2 or moderate. Grade 3 or severe, Grade 4 or Adverse event with risk of mortality or disability and Grade 5 or Death associated with an adverse event), Causal relationship (causation definite, very likely, probable, possible, unrelated, unknown), Severity (not serious/not serious, requires hospitalization, prolongs hospitalization, results in disability, life-threatening, causes death), Attitude toward treatment (no change , dose modification, temporary interruption, permanent interruption), AE outcome (recovered without sequelae, sequelae not requiring treatment, sequelae requiring treatment, death)). Measurement time: From the beginning of treatment until 24 months	—

Measure

Time frame

1. Objective response (Performed using RECIST criteria and classified as Complete response, Partial response, Stable disease or Disease progression). Measurement time: At baseline and, every 3 months during 24 months 2. Adverse Events- AE (It will be measured taking into account Type of AE (Dermatological system disease, Gastrointestinal system disease, Respiratory system disease, general, and others), Duration of the AE (time from start AE until finish AE), AE intensity (Grade 1 or mild, Grade 2 or moderate. Grade 3 or severe, Grade 4 or Adverse event with risk of mortality or disability and Grade 5 or Death associated with an adverse event), Causal relationship (causation definite, very likely, probable, possible, unrelated, unknown), Severity (not serious/not serious, requires hospitalization, prolongs hospitalization, results in disability, life-threatening, causes death), Attitude toward treatment (no change , dose modification, temporary interruption, permanent interruption), AE outcome (recovered without sequelae, sequelae not requiring treatment, sequelae requiring treatment, death)). Measurement time: From the beginning of treatment until 24 months

—

Countries

Cuba

Contacts

Public ContactLorena Requeiro Rodriguez

Center of Molecular Immunology (CIM)

lorena@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026