CIMAvax-EGF-Platelets-Adults- Lung Cancer

Not Applicable

Recruiting

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

• Registration Number: RPCEC00000284
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients of any sex and age similar or more than 18 years.
2. Patients that complete the diagnostic criteria.
3. Patients included in another clinical trial in which the therapeutic vaccine CIMAvax-EGF® is administered, or that they don't receive products in investigation and be managed follow up the Cuban Guide of treatment of patient with lung cancer 2016 version.
4. Patient that have signed the informed consent for the investigation.
5. Patient with performan status (ECOG) state from 0 at 3

Exclusion Criteria

1. Patient in fertile age that are not using an appropriate (intra-uterine devices, hormonal contraceptives, barrier methods or bond of trumpets) method of contraception. For the males (vasectomy, use of preservatives) while the treatment lasts
2. Pregnant, lactating or puerperal patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival: (Time from recruitment until death from any cause). Measurement time: 24 months

Secondary Outcome Measures

Name	Time	Method
1.Platelets (Platelets count). Measurement time: At diagnosis, 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment.<br>2.EGF serum concentration (Concentration of EGF in serum). Measurement time: At diagnosis, 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment. <br>3.Immune status of the patient (Percent and absolute value of T CD4+, T CD8+CD28- cells and TCD4/CD8 index, T regulators cells). Measurement time: 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment<br><br><br>