Evaluation of biomarkers associated with the clinical efficacy of the CIMAvax-EGF® vaccine in advanced (IIIB and IV stages) non-small cell lung cancer (NSCLC) patients. Exploratory study of biomarkers.

Center of Molecular Immunology0 sites130 target enrollmentOctober 20, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 20, 2021

End Date

October 1, 2027

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Center of Molecular Immunology

•1\. Patients who have signed the informed consent for the research.
•2\. Patients of any sex and age, greater than or equal to 18 years.
•3\. Patients who meet the diagnostic criteria.
•4\. Patients with available paraffin tissue block.
•5\. Patients with clinical status criteria (ECOG) from 0 to 2\.
•6\. Patients who have achieved a response (complete or partial) or stable disease (not progressive) after the first line of cancer\-specific treatment.
•7\. Patients with a life expectancy of 6 months or more.

•1\. Patients of childbearing potential who are not using an adequate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). In the case of males (vasectomy, use of condoms) while the treatment lasts
•2\. Pregnant, lactating or postpartum patients.
•3\. Patients who are participating in another clinical trial or who have been treated with specific immunotherapy with CIMAvax\-EGF in the previous 6 months.
•4\. Patients with uncontrolled intercurrent illnesses including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus, arterial hypertension and psychiatric illnesses that imply the incompetence of the subject.
•5\. Patients with acute allergic states or history of severe allergic reactions.
•6\. Patients with brain metastases.