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 个研究点目标入组 130 人开始时间: 2021年10月20日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•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.

发起方

Center of Molecular Immunology