CIMAvax-EGF/Lung cancer/Biomarkers/Prospective CT

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.

Scientific title:

Evaluation of biomarkers associated with the clinical efficacy of the CIMAvax-EGF® vaccine in advanced (IIIB and IV stages) non-small cell lung cancer (NSCLC) patients. Exploratory study of biomarkers.

Secondary indentifying numbers:

pending

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology, Cuban Ministry of Public Health (MINSAP), Innovative Immunotherapy Alliance (IIA)

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:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Ramon

Midle name:

Alberto

Last name:

Ortiz Carrodeguas

Medical Specialty :

MD, First Degree Specialist in Oncology

Affiliation:

Celestino Hernandez Robau Hospital

Postal address:

Cuba No. 564 entre Barcelona y Hospital

City:

Santa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-42271202

+53-42279442

Email address:

raortizcarrodeguas@gmail.com [1]

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:

01/12/2021

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:

Advanced non small cell lung cancer

Health condition(s) code:

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intervention(s):

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 every 14 days. Prior to the first dose of the vaccine, immunomodulatory dose cyclophosphamide (200mg/m2, IV) was administered Maintenance stage: Administrations every 28 days until the patient's clinical conditions allow.

Intervention code:

Biomarkers, Tumor

Immunotherapy, Active

Epidermal Growth Factor

Cyclophosphamide

Injections, Intramuscular

Administration, Intravenous

Intervention keyword:

CIMAvax-EGF

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. 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 disease progression, or death from any cause). Measurement time: Every 3 months, during 3 years.

Key secondary outcomes:

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.

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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:

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.

Type of population:

Adults

Type of participant:

Patients

Study design

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

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

130

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:

Geidy

Last Name:

Lorenzo Monteagudo

Specialty:

BSc. in Pharmaceutical Sciencies

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

CP 16040, Box 11600

Telephone:

+53-53806987

Email :

geydi@cim.sld.cu [2]

geidylm72@gmail.com [3]

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:

Danay

Last Name:

Hernandez Saavedra

Specialty:

MD. First Degree Specialist in Immunology

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

CP 16040, Box 11600

Telephone:

+53-72717933 ext 3391

Email :

danays@cim.sld.cu [4]

Research Ethics Committees

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

Name of Research Ethics Committees:

Celestino Hernandez Robau Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

04/08/2021

Postal address of Ethic Committee :

Cuba street 564 between Barcelona and Hospital. Santa Clara, Villa Clara. ZC 50100, Cuba

Telephone:

53-42279401

Correo electrónico:

direccion@hchr.vcl.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

01/12/2026

Date of available results:

01/10/2027

Date of first publication:

01/12/2027

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:

RPCEC00000392

Date of Registration in Primary Registry:

20/10/2021

Record Verification Date:

2021/11/01

Next update date:

2022/11/01

Link to the spanish version:

Click here [5]