Safety and efficacy of CIMAvax®-EGF in combination with tyrosine kinase inhibitors in patients with advanced stage Non-Small Cell Lung Cancer and EGFR mutations

Phase 2

• Conditions: ung Cancer; Thoracic Neoplasms; Respiratory Tract Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Respiratory Tract Diseases

• Registration Number: RPCEC00000371
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-22
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-31
• Results First Posted: 2025-03-31

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients with cytological / histological confirmation of lung cancer in advanced stages, carriers of EGFR mutations.
2. Patients of any sex and age greater than or equal to 18 years.
3. Patients who have signed the informed consent for the research.
4. Patients with general clinical status according to the ECOG scale of 0 to 2.
5. Patients with a life expectancy equal to or greater than 6 months.
6. Patients who have functioning organs defined by the following parameters:
. Hemoglobin =90 g / L
. Total leukocyte count = 3.0 x 109 / L
. Absolute neutrophil count =1.5 x 109 / L
. Platelet count =100 x 109 / L
. Total bilirubin: Within normal limits.
. TGP and TGO: 2.5 times the institutional upper normal limit.
. Glycemia: Within normal limits for each institution.
. Creatinine: 2.0 times the institutional upper normal limit.
7. Life expectancy of at least 6 months

Exclusion Criteria

1. Patients with uncontrolled intercurrent diseases that include, but are not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and psychiatric diseases that imply the incompetence of the subject.
2. Patients with autoimmune diseases or decompensated chronic diseases.
3. Patients with acute allergic conditions or history of severe allergic reactions.
4. Patients with brain metastases or other primary neoplastic lesion.
5. Patients with a previous history of demyelinating or inflammatory diseases of the CNS or peripheral.
6. Patients with other malignancy in the previous 5 years, except skin cancer (not melanoma).
7. Patients receiving another investigational product.
8. Pregnant or lactating patients.
9. Patients of childbearing potential who are not using an adequate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation).
10. Patients with known positive serology for Hepatitis B, C or HIV.
11. Patients with known hypersensitivity to any component of CIMAvax®-EGF or to the molecule of tyrosine kinase inhibitors.
12. Patients with hereditary galactose intolerance, total lactase deficiency, or glucose or galactose absorption problems.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of individuals with serious adverse events related to the use of CIMAvax® in combination with tyrosine kinase inhibitors (Percentage of patients with adverse events whose severity is classified as serious and whose causal relationship is definite, highly probable, probable or possible) . Measurement time: Weeks 0,2,4,6,10,14,18,22,26,30,34,38,42,46,50.