CIMAvax-EGF in patients at high risk of lung cancer

Phase 1

• Conditions: ung cancer; Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

• Registration Number: RPCEC00000339
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-22
• Study Completion: 2023-02-05
• Results First Posted: 2023-09-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients who meet the diagnostic criteria according to the cohort to which they belong.
2. Patients aged = 18 years for survivors of lung cancer 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 age who consent to the use of appropriate contraceptive methods (for example, hormonal or barrier contraceptive methods, withdrawal) 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 to participate in writing.
In addition to the above criteria, patients must meet the following specific criteria of 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 packages / year.
4. Have the lung function test in the last 3 months before inclusion.
Survivors of early stage lung cancer (Cohort B).
1. Having completed 3 months before inclusion, adjuvant therapy for lung cancer after surgery, with no evidence of early disease progression.
2. CPCNP confirmed in stage IB to IIIA in the initial diagnosis (TNM 8th edition).

Exclusion Criteria

1. Patients not clinically fit to undergo the bronchoscopy procedure.
2. Patients with uncontrolled intercurrent diseases that include, among others, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
3. Patients with stage IIIA who are not surgical.
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 breastfeeding patients.
7. Patients with another malignant disease in the previous 5 years, except skin cancer (not melanoma).
8. Patients who have received another product under investigation within 30 days prior to inclusion.
9. Patients who have received treatment for their disease with immunotherapy.
10. Patients with known immunosuppressive disease (for example, HIV, AIDS or other immunosuppressive disease). The test is not mandatory.
11. Patients with known hypersensitivity to the vaccine components under study or any analogue.
12. Patients requiring steroid treatment equivalent to doses greater than 20 mg of prednisone daily.
13. Patients reluctant or unable to follow the requirements of the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.EGF concentration (The concentration of EGF in patients' blood will be determined in pg / mL). Time of measurement: At baseline, at 14 days (+3) after the end of the induction phase (4th dose of the vaccine) and at 14 days (+3) of the evaluation at the end of the treatment under study (8th dose of the vaccine).<br>2.Anti-EGF antibody titers (In each patient the antibody titres will be determined in response to short-term vaccination and it will be determined if it is = 1: 4000). Time of measurment: At baseline, 14 days (+3) after the end of the induction phase (4th dose of the vaccine) and, 14 days (+3) of the evaluation at the end of the treatment under study (8th dose of the vaccine).