CIMAvax-EGF vaccine Predictor Phase IV

Phase 4

• Conditions: Advanced non small cell lung cancer (NSCLC); Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms

• Registration Number: RPCEC00000205
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-14
• Study Completion: 2022-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients of either sex and greater than or equal to 18 years.
2. Patients who met the diagnostic criteria.
3. Non-eligible patients for chemotherapy or radiotherapy or who have received the treatment oncospecific available and have no other treatment option.
4. Patients who have signed informed consent for research.
5. Patients with clinical criteria status (ECOG) 0 to 3.
6. Patients with a life expectancy greater than or equal to 3 months.

Exclusion Criteria

1. Patients participating in another clinical trial.
2. Patients who have been treated with specific immunotherapy CIMAvax-EGF in the previous 6 months.
3. Patients who present a history of hypersensitivity to compounds similar to the vaccine or other component of the product formulation biological or chemical composition.
4. Patients of childbearing age who are not using an appropriate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). If male (vasectomy, condoms) during treatment
5. Patients who are pregnant, breastfeeding or postpartum.
6. Patients with brain metastases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious Adverse Event, expected or unexpected, with definite or probable causality relationship with the study product. Measuring time: monthly for two years.