Non small cell lung cancer NSCLC
Conditions
Interventions
Group I: Monthly immunization with CIMAvax-EGF after induction, up to two years..
Group II: Immunization with CIMAvax-EGF after induction, every two months, up to two years..
Group III: Immunization w
Immunotherapy, Active
Epidermal Growth Factor
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with a cytological / histological diagnosis of non-small cell lung carcinoma in all stages IIIb and IV, of any sex and age equal to or greater than 18 years, who have completed at least 2 cycles of first-line chemotherapy. 2. Patients who have signed the informed consent for the research. 3. Patients with clinical status criteria (ECOG) from 0 to 2.
Exclusion criteria
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 males (vasectomy, use of condoms) while the treatment lasts. 2. Pregnant, lactating or postpartum patients. 3. 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. 4. Patients with brain metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Titer of antibodies against EGF. Measurement time: before the 1st immunization, and then monthly for 2 years. - Concentration of EGF in serum. Measurement time: before the 1st immunization, and then monthly for 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Survival Time (total time that the patient lives since the first immunization): Measurement time: from the date of inclusion to the date of death. | — |
Countries
Cuba
Contacts
Public ContactDanay Saavedra Hernandez
Center of Molecular Immnunology (CIM)
Outcome results
None listed