CIMAvaxEGF in Non Small Cell Lung Cancer. Exploratory Study of Biomarkers

Not Applicable

• Conditions: on-Small Cell Lung Cancer (NSCLC)

• Registration Number: RPCEC00000445
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-20
• Last Update Posted: 19 August 2024
• Study Completion: 2028-11-19
• Results First Posted: 2029-02-20

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients who have signed the informed consent for the research .
2. Patients of any sex and older than 19 years.
3. Patients who meet the diagnostic criteria.
4. Patients with clinical status criteria (ECOG) of 0 a2.
5. Patients who have achieved partial response or stable disease after the first line of onco-specific treatment.
6. Patients with a life expectancy of 6 months or more.

Exclusion Criteria

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 the male sex (vasectomy, use of condoms) while the treatment lasts
2. Pregnant, breastfeeding 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 diseases that include, but are not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus, arterial hypertension and psychiatric diseases that imply the incompetence of the subject.
5. Patients with acute allergic states or history of severe allergic reactions.
6. Patients with brain metastasis.

Study & Design

• Study Type: Observational
• Study Design: Not specified