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

Phase 1

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

• Registration Number: RPCEC00000370
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-21
• Study Completion: 2023-09-29
• Results First Posted: 2023-12-29
• 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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified