Revisions for Biomodulina T- CIMAvax-EGF-Advanced Non-Small Cell Lung Cancer-Adults | Registro Público Cubano de Ensayos Clínicos

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Current revision:

Biomodulina T- CIMAvax-EGF-Advanced Non-Small Cell Lung Cancer-Adults

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:

BT- CIMAvax

Scientific title:

Assessment of the impact of Biomodulina T at the conclusion of first-line chemotherapy in patients diagnosed with non-small cell lung cancer, on the proportion of CD4+ T cells and terminally differentiated CD8+CD28 T cells, as well as the evaluation of these cell populations as possible biomarkers of the CIMAvax-EGF vaccine efficacy

Acronym of Scientific Title:

BT- CIMAvax-EGF-NSCLC

Secondary indentifying numbers:

PL023

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM)

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:

Mauricio

Last name:

Catala Ferrer

Medical Specialty :

Second Degree Specialist in Oncology

Affiliation:

Surgical Medical Research Center (CIMEQ)

Postal address:

216th and 11th Street, Siboney, Playa

City:

Havana

Country:

Cuba

Zip Code:

12100

Telephone:

+53-78581000

Email address:

mcatalafe@infomed.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:

Recruiting

Date of first enrollment:

21/02/2019

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

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):

Experimental group: Biomodulina T + CIMAvax-EGF Biomodulina T: It will be administered 3mg intramuscular, 3 times per week (9mg per week) will be administered for 4 weeks. At the end of treatment with Biomodulina T, the CimaVax-EGF vaccine will be administered. CIMAvax-EGF. The vaccine will administer 2.4 mg total in each immunization at 4 inoculation sites (intramuscular administration) with an amount equivalent to 0.6mg in a volume of 1.2 mL. Indication: induction stage and maintenance stage. Induction stage: Four weekly administrations every 14 days (4 administrations) and, 5th immunization a month after last immunization. Maintenance stage: Administration every 28 days until the patient's clinical conditions allow. Prior to the first dose of the vaccine, immunomodulatory dose cyclophosphamide (200 mg / m2, intravenous) will be administered.

Intervention code:

Immunotherapy, Active

Immunologic Factors

Immunomodulation

Epidermal Growth Factor

Cyclophosphamide

Injections, Intramuscular

Intervention keyword:

Biomodulin T, 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. Subpopulations of T lymphocytes (CD4 + CD28-, TCD8 + CD28- and CD19 + IgD-CD27-, all values are expresed in percent). Measurement time: before and after platinum-based chemotherapy, at the end of the administration of Biomodulin T, at 3, 6 and 12 months of administration of the Cimavax-EGF vaccine. 2. Titer of Ab anti EGF (inverse of the last dilution in which a higher O.D. than the average of the blanks was obtained). Measurement time: at the end of chemotherapy, at the end of the administration of Biomodulin T, at 3, 6 and 12 months of administration of the Cimavax-EGF vaccine. 3. EGF concentration (measured in pg / ml). Measurement time: at the end of chemotherapy, at the end of the administration of Biomodulin T, at 3, 6 and 12 months of administration of the Cimavax-EGF vaccine.

Key secondary outcomes:

Survival time (Time from inclusion until death) Measurement time: every year for two years from inclusion.

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 of any sex and age over or equal to 18 years old. 2. Patients diagnosed with cyto/histological carcinoma of non-small lung cells in all stages IIIb and IV 3. Patients who have signed informed consent for research 4. Patients with clinical status criteria (ECOG) from 0 to 2

Exclusion criteria:

1. Patients of childbearing potential who are not using an appropriate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). In case of male sex (vasectomy, condom use) for the duration of treatment. 2. Pregnant, lactating or post-breastfeeding patients.

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:

Recruitment for time

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:

Danay

Last Name:

Saavedra Hernandez

Specialty:

First Degree Specialist in Immunology and Family medicine.

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 St, corner 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

16040

Telephone:

+53-72143164

Email :

danays@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:

Gisela

Middle Name:

Maria

Last Name:

Suarez Formigo

Specialty:

First Degree Specialist in Immunology

Affiliation:

Center for Molecular Immunology (CIM)

Postal Address:

216 St, corner 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

16040

Telephone:

+53-72143164

Email :

gisela@cim.sld.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Surgical Medical Research Center (CIMEQ)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

17/05/2018

Postal address of Ethic Committee :

216 street and 11B, Reparto Siboney. Playa. Havana

Telephone:

+53-72718424

Email:

bcimeq@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

29

Study completion date:

21/02/2023

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:

RPCEC00000358

Date of Registration in Primary Registry:

18/03/2021

Record Verification Date:

2021/03/19

Next update date:

2022/03/19

Link to the spanish version:

Click here

Registered Trials

Registration process

Biomodulina T- CIMAvax-EGF-Advanced Non-Small Cell Lung Cancer-Adults

About the RPCEC

Useful resources