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

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

EMA-Lung

Scientific title:

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

Acronym of Scientific Title:

EMA-Lung

Secondary indentifying numbers:

FL-EC0031

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM); Cuban Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Mary

Midle name:

Carmen

Last name:

Marrero Diaz

Medical Specialty :

First Degree Specialist in Oncology

Affiliation:

National Center for Minimally Invasive Surgery (CNCMA)

Postal address:

Parraga 215 e/ San Mariano y Vista Alegre. La Vibora, 10 de Octubre

City:

Havana

Country:

Cuba

Zip Code:

10700

Telephone:

+53-53717653

Email address:

maryc4marrero@gmail.com

marycarmen@cce.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/07/2024

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Non-Small Cell Lung Cancer (NSCLC)

Intervention(s):

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 administered every 14 days until completing 4 doses. In the maintenance stage, a dose will be administered every 28 days, until the appearance of unmanageable toxicity or worsening of the patient's general condition (above 3 according to the ECOG scale). Treatment with the vaccine will be maintained as long as the patient does not show a significant deterioration in their general condition. Prior to receiving the first dose of the vaccine, a low dose of cyclophosphamide (200 mg/m2) will be administered intravenously.

Outcomes and Timepoint

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- 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 survival (Time from the date of inclusion in the study until the date of disease progression, or death from any cause). Measurement time: every 3 months during 24 months

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

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:

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Observational

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

20

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Lorena

Last Name:

Requeiro Rodriguez

Specialty:

General Medicine

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 street and 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72717933 ext. 3489

Email :

lorena@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Lorena

Last Name:

Requeiro Rodriguez

Specialty:

General Medicine

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 street and 15, Atabey, Playa, Havana

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72717933 ext. 3489

Email :

lorena@cim.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

National Center for Minimally Invasive Surgery (CNCMA)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

01/03/2024

Postal address of Ethic Committee :

Calle Parraga No. 215 e/ Vista Alegre y San Mariano, Municipio 10 de Octubre. ZC: 10700, Havana. Cuba

Telephone:

+53-58056239

Email:

fpinol@infomed. sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

04/01/2028

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000445

Date of Registration in Primary Registry:

20/06/2024

Record Verification Date:

2024/06/20

Next update date:

2025/06/20

Link to the spanish version:

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

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