Non Small Cells Lung Cancer
Conditions
Interventions
Study Group (Vaccine): Day 1 Cyclophosphamide 200 mg/m2. Day 4 EGF vaccine 2.4 mg quarterly up to 4 doses and thereafter every 28 days until . Treatment of the pain and supportive care if required. Co
Sponsors
Centre of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Have histologically and/or cytologically confirmed diagnosis of NSCLC, corresponding to locally and regionally advanced, inoperable disease (Stage IIIb or Stage IV) 2.Aged >18 years 3.Have adequate bone marrow, liver and renal function, as assessed by the Investigator. A sample taken at Screening should confirm that: - Hemoglobin = 9 g/L - White blood cell (WBC) count = 3000/ µL - Neutrophils = 1500/µL - Platelet count = 100,000 per µL - Total bilirrubin in normal labs values - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x upper limit of normal (ULN) Serum creatinine = 1.5 x ULN 4.Life expectancy at least 3 years 5. Agree to use double-barrier contraception (males and females alike [if applicable]). A negative pregnancy test must be documented at Screening for females of childbearing potential. 6.Females of childbearing potential are defined as those women with less than 2 years after last menstruation and not surgically sterile, while post-menopausal refers to those women with at least 2 years from last menstruation. 7.Have signed a voluntary written informed consent form (ICF). Patients should be cooperative, willing and able to participate and adhere to the Protocol requirements, including their availability for the follow-up. 8.Are eligible to receive first-line chemotherapy (without concurrent thoracic radiotherapy or consolidation radiotherapy). 9.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 10.Achieve tumor Objective Response of at least stable disease by RECIST.
Exclusion criteria
Exclusion criteria: 1.Patient is currently enrolled in other investigational drug trial. 2.Patient has a history of any severe or life-threatening hypersensitivity reaction. 3.Patient has an unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease). 4.Pregnant woman 5.Another active concurrent malignant disease except non- melanoma skin lesions or cervix cancer. 6.Brain metastases (Only if detectable by radiological image scan previous sign or symptoms).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival (Alive, Dead). Measuring time: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (name of event, intensity, SAE and death related to the product). Measuring time: every immunization Quality of Life (EORTC QLQ-30, EORTC QLQ-CC13). Measuring time: every 3 months until 24 months. | — |
Countries
Cuba
Contacts
Public ContactPedro Rodriguez Rodriguez
Centre of Molecular Immunology
Outcome results
None listed