Advanced non small cell lung cancer (NSCLC)
Conditions
Interventions
Experimental group: CIMAvax-EGF therapeutic vaccine. The vaccine will be administrated by intramuscular route, a dose of 2,4 mg. The first four doses (induction stage) will be administered every 14 da
CIMAvax-EGF vaccine
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients of either sex and greater than or equal to 18 years. 2. Patients who met the diagnostic criteria. 3. Non-eligible patients for chemotherapy or radiotherapy or who have received the treatment oncospecific available and have no other treatment option. 4. Patients who have signed informed consent for research. 5. Patients with clinical criteria status (ECOG) 0 to 3. 6. Patients with a life expectancy greater than or equal to 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients participating in another clinical trial. 2. Patients who have been treated with specific immunotherapy CIMAvax-EGF in the previous 6 months. 3. Patients who present a history of hypersensitivity to compounds similar to the vaccine or other component of the product formulation biological or chemical composition. 4. Patients of childbearing age who are not using an appropriate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). If male (vasectomy, condoms) during treatment 5. Patients who are pregnant, breastfeeding or postpartum. 6. Patients with brain metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious Adverse Event, expected or unexpected, with definite or probable causality relationship with the study product. Measuring time: monthly for two years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Security Related: Adverse Events (AE): Measuring time: inclusion and monthly for two years. Measured as: 1. Occurrence of any AE (yes, no) 2. Description of AE(name of adverse event). 3. Time of onset of AE(difference between start and completion of the EA) 4. Seriousness of AE (1. Serius, 2 No serious) 5. Intensity of AE (1. Light, 2. Moderate 3. Severe, 4. Very severe 5. Death) 6. Causality relationship (1.Very Likely/Safe/final, 2. Likely 3. Possible, 4. Unlikely 5. unrelated 6. Unknown) 7. Attitude followed by the appearance of AE (1. No change 2. Modification of dose 4. 3.Interrupción temporary or definitive interruption) 8. Result of the AE (1. Recovered, 2. Improved , 3. Persists or Consequences.) 9. Batch of vaccine CIMAvax-EGF® (Batch Number of the vaccine) -Hemoglobin (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18 and 24 months -White blood cell count with differential (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Hematocrit (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Platelets (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) (numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Glycemic (Nnumeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Bilirubin (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Alkaline phosphatase (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months Related effectiveness -Time Overall survival (time between inclusion and the date of death of the patient). Measuring time: at baseline, and monthly for two ye | — |
Countries
Cuba
Contacts
Public ContactPedro Guerra Chaviano
National Coordinating Center for Clinical Trials
Outcome results
None listed