CIMAvax-EGF-Platelets-Adults- Lung Cancer

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 the behavior of platelets count, EGF serum concentrations and the levels of lymphocytes subpopulations expression associated with the patient's immune status as possible biomarkers of effectiveness of CIMAvax-EGF vaccine.

Secondary indentifying numbers:

FL-EC-020

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)

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:

Ramon

Midle name:

Alberto

Last name:

Ortiz Carrodeguas

Medical Specialty :

Medical Doctor, first degree specialist in Oncology

Affiliation:

“Celestino Hernandez Robau” Hospital

Postal address:

Calle Cuba No. 569 entre Hospital y Alejandro Oms

City:

Santa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-042279442

+53-042271202

Email address:

ramonoc@infomed.sld.cu [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

Research ethics committees:

“Celestino Hernandez Robau” Hospital, April 12, 2017

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

12/12/2017

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

Health condition keyword:

NSCLC

Intervention(s):

Group CIMAvax-EGF (experimental): CIMAvax-EGF therapeutic vaccine, 2.4 mg by intramuscular route. The first 4 administrations will be every 14 days (induction stage) and, the rest of vaccines will administer every 28 days (maintenance stage) until the patient's clinical conditions allow. Prior to the first dose of the vaccine, immunomodulatory dose of cyclophosphamide (200 mg / m2, intramuscular route) will be administered.

Intervention code:

Immunotherapy, Active

Epidermal Growth Factor

Injections, Intramuscular

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):

Overall Survival: (Time from recruitment until death from any cause). Measurement time: 24 months

Key secondary outcomes:

1. Platelets (Platelets count). Measurement time: At diagnosis, 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment. 2. EGF serum concentration (Concentration of EGF in serum). Measurement time: At diagnosis, 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment. 3. Immune status of the patient (Percent and absolute value of T CD4+, T CD8+CD28- cells and TCD4/CD8 index, T regulators cells). Measurement time: 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment

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 similar or more than 18 years. 2. Patients that complete the diagnostic criteria. 3. Patients included in another clinical trial in which the therapeutic vaccine CIMAvax-EGF® is administered, or that they don't receive products in investigation and be managed follow up the Cuban Guide of treatment of patient with lung cancer 2016 version. 4. Patient that have signed the informed consent for the investigation. 5. Patient with performan status (ECOG) state from 0 at 3

Exclusion criteria:

1. Patient in fertile age that are not using an appropriate (intra-uterine devices, hormonal contraceptives, barrier methods or bond of trumpets) method of contraception. For the males (vasectomy, use of preservatives) while the treatment lasts 2. Pregnant, lactating or puerperal 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:

Patients to recruit in 18 months

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 Phamaceutical Sciences

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

ZP 16040, Box 11600

Telephone:

+53-72717933

Email :

geydi@cim.sld.cu [2]

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:

First Degree Specialist in Immunology and Comprehensive General Medicine.

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 Esquina 15, Atabey, Playa.

City:

Havana

País:

Cuba

Zip Code:

ZP 16040, Box 11600

Telephone:

+53-72717933

Email :

danay@cim.sld.cu [3]

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:

RPCEC00000284

Date of Registration in Primary Registry:

03/08/2018

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

Link to the spanish version:

Click here [4]