Preventive use of CIMAvax-EGF in patients at high risk of lung cancer. PREVAX

• Register: RPCEC
• Last refreshed on: 21 June 2021
• Main ID: RPCEC00000370
• Date of registration: 21/05/2021
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Preventive use of CIMAvax-EGF in patients at high risk of lung cancer. PREVAX
• Scientific title: Preventive use of CIMAvax-EGF in patients at high risk of lung cancer. PREVAX - PREVAX
• Date of first enrolment: 01/06/2021
• Target sample size: 60
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000370-En
• Study type: Interventional
• Study design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Prevention
• Phase: 1

Countries of recruitment

Cuba

Contacts

• Name: Pedro Pablo Pino Alfonso
• Affiliation: Hermanos Ameijeiras Clinical Surgical Hospital (HHA)

• Name: Orestes Santos Morales
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria according to the cohort to which they belong.
2. Patients aged = 18 years for lung cancer survivors and between 50 and 79 years for patients at high risk of lung cancer.
3. Patients who do not have imaging evidence of lung cancer, evaluated by CT according to RECIST criteria.
4. Patients of childbearing potential who consent to the use of adequate contraceptive methods (eg, hormonal or barrier methods of contraception, abstinence) before being included in the study. If a woman becomes pregnant or suspects that she is pregnant while she or her partner is participating in this study, she should inform her doctor immediately.
5. Patients who give their informed consent for participation in writing. In addition to the above criteria, patients must meet the following criteria specific to the cohort in which they will be included:
Patients at high risk of lung cancer (Cohort A).
1. Document the presence of any of these risk factors
• Moderate or severe COPD.
• Family history of lung cancer.
• Low body mass index.
• Recent pneumonia.
2. Have quit smoking in the last 10 years or be a current smoker.
3. Have a history of smoking at least 50 packs / year.
4. Have a pulmonary function test in the last 3 months before inclusion.
Early Stage Lung Cancer Survivors (Cohort B).
1. Completion of adjuvant therapy for lung cancer after surgery 3 months prior to enrollment, with no evidence of early disease progression.
2. NSCLC confirmed stage IB to IIIA at initial diagnosis (TNM 8th edition).
Exclusion criteria: 1. Patients clinically unfit to undergo the bronchoscopy procedure.
2. Patients with uncontrolled intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
3. Stage IIIA non-surgical patients.
4. Patients with mild or very severe COPD.
5. Patients with psychiatric illness and / or social situations that would limit compliance with the study requirements.
6. Pregnant or lactating patients.
7. Patients with other malignancy in the previous 5 years, except skin cancer (non-melanoma).
8. Patients who have received another investigational product within 30 days prior to inclusion.
9. Patients who have received treatment for their disease with immunotherapy.
10. Patients with known immunosuppressive disease (eg, HIV, AIDS, or other immunosuppressive disease). The test is not mandatory.
11. Patients with known hypersensitivity to the components of the vaccine under study or any analogue.
12. Patients requiring steroid treatment equivalent to doses greater than 20 mg of prednisone per day.
13. Patients reluctant or unable to follow the requirements of the protocol

Age minimum: 18 years
Age maximum: 79 years
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Bronchial Neoplasms

Carcinoma, Bronchogenic

Carcinoma, Non-Small-Cell Lung

Lung cancer

Lung Diseases

Lung Neoplasms

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Intervention(s)

Administration, Intravenous

CIMAvax-EGF

CIMAvax®-EGF (Experimental group). CIMAvax®-EGF, 2.4 mg per dose. The first 4 doses will be administered every 14 days and the remaining 4 doses, every 28 days until reaching 8 doses. The duration of the treatment will be 6 months. The product will be administered intramuscularly divided into 4 subdoses, equivalent to 0.6 mg of EGF at each site of inoculation (both deltoid regions and both glutes). Prior to receiving the first dose of the vaccine (72 hours), patients will receive a single dose of cyclophosphamide (CMF) 200 mg / m2 intravenously.

Cyclophosphamide

Epidermal Growth Factor

Immunotherapy, Active

Injections, Intramuscular

Primary Outcome(s)

1. EGF concentration (the EGF concentration in the blood of the patients expressed in pg / mL will be determined). Measurement time: At baseline, 14 days (+3) from the end of the induction phase (4th dose of the vaccine) and 14 days (+3) from the evaluation at the end of the study treatment (8th dose of the vaccine) .
2. Anti-EGF antibody titers (measurement of anti-EGF antibody titers will be performed in response to short-term vaccination and will determine if it is = 1: 4000). Measurement time: At baseline, 14 days (+3) after the end of the induction phase (4th dose of the vaccine) and 14 days (+3) after the evaluation at the end of the study treatment (8th dose of the vaccine).
3. Serum IL-6 concentration. (pg / ml). Measurement time: At baseline, weeks 8 and 24.
4. Total bilirubin. (mg / dL). Measurement time: At baseline, weeks 8 and 24.
5. Neutrophil / lymphocyte ratio (neutrophil / lymphocyte ratio). Measurement time: At baseline, weeks 8 and 24.
6. Platelet / lymphocyte ratio (platelet / lymphocyte ratio). Measurement time: At baseline, weeks 8 and 24.
7. Absolute count and frequency of CD4 + T cells (total and%). Measurement time: At baseline, weeks 8 and 24. 7.
8. Absolute count and frequency of CD8 + T cells (total and%). Measurement time: At baseline, weeks 8 and 24. 8.
9. CD4 / CD8 Index (CD4 / CD8 Ratio). Measurement time At baseline, weeks 8 and 24.

Secondary Outcome(s)

1. (Occurrence of an AE (Yes, No), Type of AE (according to the CTC version 5.0 nomenclature), Duration of the AE (Differences between the start and end dates of the AE), Intensity of the AE (Light, Moderate, Severe, Severe threatening or incapacitating, Severe causing death, according to CTC version 5.0), Causation of AE (Definitive, Very likely, Probable, Possible, Unrelated, Unknown), Severity of AE (Yes, No. In case of seriousness, it will be classified according to the categories of: causes the death of the patient, threatens life, requires hospitalization or prolongs an existing hospitalization, produces a disability, significant or persistent disability, produces a birth defect or a congenital anomaly), Attitude versus the treatment under study (No changes, Dose modification, Temporary interruption of treatment, Definitive interruption of treatment, according to the attitude decided by the clinical investigator), AE Result (Recovered, Improved, Persists, Sec uelas)). Measurement time: Weeks 0, 2, 4, 6, 8, 10, 14, 18, 22, 24 and 30.
2. Clinical response (For patients included in Cohort A, it will be evaluated through the respiratory function test and the COPD status will be collected at the end of treatment according to the GOLD criteria. For patients included in Cohort B, it will be evaluated through imaging and will collect the control of the disease in local relapse or relapse at a distance). Measurement time: At baseline, and at week 24 from the beginning of CIMAvax-EGF treatment.

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Hermanos Ameijeiras Clinical Surgical Hospital (HHA)

Ethics review

Status: In review
Approval date: 07/04/2021
Contact:

[e-mail]

[e-mail]

[phone]

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Results

• Date Posted: 29/09/2023
• Date Completed: 29/09/2023