Lung Cancer
Conditions
Interventions
Experimental group: Cimavax-EGF. 2.4 mg per dose. The first 4 doses will be administered every 14 days and the remaining every 28 days, combined with tyrosine kinase inhibitors (gefitinib 250 mg or os
Immunotherapy, Active
Epidermal Growth Factor
Protein-Tyrosine Kinases
Gefitinib
Cyclophosphamide
Injections, Intramuscular
Administration, Intravenous
Administration, Oral
CIMAvax-EGF,
osimertinib
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events-AE (Type of AE (according to CTC version 4.0 nomenclature), AE duration (Difference between AE start and end date), AE intensity (mild, moderate and severe), AE severity (It will be evaluated according to the serious / non-serious categories), attitude towards the study drug (1. No change, 2. Dose modification, 3. Temporary interruption or 4. Definitive interruption), AE result (Recovered, Improved, Persists , Sequelae), causal relationship of AE (Definitive, Very Probable, Probable, Possible, Not related, Unknown) Measurement time: Weeks 0,2,4,6,10,14,18,22,26,30,34 , 38,42,46,50) 2. Progression Free Survival (Time from randomization of the patient in the study to progression or death of the patient). Measurement time: Every 3 months for 1 year. 3. Overall Survival (Time from patient randomization in the study to death or date of latest news). Measurement time: Monthly for 1 year. 4. Objective response (According to RECIST criteria version 1.1 classified as Complete response, Partial response, stable disease, disease in progression). Measurement time: every 3 months for one year). 5. Quality of life (It will be measured through the EORTC surveys validated for this disease (QLQ-C30 and QLQ-LC13), in addition to the evaluation of the patient's Performance Status at each indicated moment. Measurement time: every three months for 1 year. 6. Serum EGF concentration (It will be measured in pg / mL using the ultramicro-ELISA system for the quantification of EGF (TECNOSUMA, CUBA). Measurement time: Day 0, Day 70, month 6, 9 and 12 and at the time of progression. 7. Inhibition of EGFR phosphorylation: (The EGFR phosphorylation fraction at a given moment of time will be measured in% compared to the initial time of the patient (100% phosphorylation) using the western blot technique. Measurement time: Day 0, Day 70, month 6, 9 and 12 and at the time of progression). 8. Antibody response against EGF (Based on the antibody response against EGF measured by ELISA | — |
Countries
Cuba
Contacts
Public ContactOrestes Santos Morales
Center of Molecular Immunology (CIM)
Outcome results
None listed