Biomodulina T- CIMAvax-EGF-Advanced Non-Small Cell Lung Cancer-Adults

Not Applicable

Recruiting

• Conditions: on-small cell lung cancer; Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

• Registration Number: RPCEC00000358
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-18
• Last Update Posted: 19 August 2024
• Study Completion: 2025-02-21
• Results First Posted: 2025-09-21

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients of any sex and age over or equal to 18 years old.
2. Patients diagnosed with cyto/histological carcinoma of non-small lung cells in all stages IIIb and IV
3. Patients who have signed informed consent for research
4. Patients with clinical status criteria (ECOG) from 0 to 2

Exclusion Criteria

1. Patients of childbearing potential who are not using an appropriate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). In case of male sex (vasectomy, condom use) for the duration of treatment.
2. Pregnant, lactating or post-breastfeeding patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Subpopulations of T lymphocytes (CD4 + CD28-, TCD8 + CD28- and CD19 + IgD-CD27-, all values are expresed in percent). Measurement time: before and after platinum-based chemotherapy, at the end of the administration of Biomodulin T, at 3, 6 and 12 months of administration of the Cimavax-EGF vaccine.<br>2. Titer of Ab anti EGF (inverse of the last dilution in which a higher O.D. than the average of the blanks was obtained). Measurement time: at the end of chemotherapy, at the end of the administration of Biomodulin T, at 3, 6 and 12 months of administration of the Cimavax-EGF vaccine.<br>3. EGF concentration (measured in pg / ml). Measurement time: at the end of chemotherapy, at the end of the administration of Biomodulin T, at 3, 6 and 12 months of administration of the Cimavax-EGF vaccine.

Secondary Outcome Measures

Name	Time	Method
Survival time (Time from inclusion until death) Measurement time: every year for two years from inclusion.