Advanced non small cell lung cancer NSCLC
Conditions
Interventions
Group CIMAvax-EGF (experimental): CIMAvax-EGF therapeutic vaccine, 2.4 mg by intramuscular route. The first 4 administrations will be every 14 days (induction stage) and, the rest of vaccines will adm
Immunotherapy, Active
Epidermal Growth Factor
Injections, Intramuscular
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients of any sex and age similar or more than 18 years. 2. Patients that complete the diagnostic criteria. 3. Patients included in another clinical trial in which the therapeutic vaccine CIMAvax-EGF® is administered, or that they don't receive products in investigation and be managed follow up the Cuban Guide of treatment of patient with lung cancer 2016 version. 4. Patient that have signed the informed consent for the investigation. 5. Patient with performan status (ECOG) state from 0 at 3
Exclusion criteria
Exclusion criteria: 1. Patient in fertile age that are not using an appropriate (intra-uterine devices, hormonal contraceptives, barrier methods or bond of trumpets) method of contraception. For the males (vasectomy, use of preservatives) while the treatment lasts 2. Pregnant, lactating or puerperal patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival: (Time from recruitment until death from any cause). Measurement time: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Platelets (Platelets count). Measurement time: At diagnosis, 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment. 2. EGF serum concentration (Concentration of EGF in serum). Measurement time: At diagnosis, 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment. 3. Immune status of the patient (Percent and absolute value of T CD4+, T CD8+CD28- cells and TCD4/CD8 index, T regulators cells). Measurement time: 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment | — |
Countries
Cuba
Contacts
Public ContactGeidy Lorenzo Monteagudo
Center of Molecular Immunology
Outcome results
None listed