ADVANCED (STAGE IIIB-IV) NON-SMALL CELL LUNG CANCER MedDRA version: 12.1 Level: LLT Classification code 10025037 Term: Lung adenocarcinoma stage III
Conditions
Sponsors
AZIENDA UNITA` SANITARIA LOCALE N 12 DI VIAREGGIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histological or cytological diagnosis of NSCLC - Age ≥ 18 years - Measurable disease according to RECIST criteria - ECOG performance status 0 - 2 - UICC-TNM stage IIIB - IV - Life expectancy > 3 months - Ability to take oral medications - Adequate organ function as determined by the following criteria: ? Absolute neutrophil count (ANC) > 1.5 109/L ? Absolute leukocytes count (ALC) > 3.0 109/L ? Platelet count > 100 109/L ? Haemoglobin > 10 g/dl ? Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Two or more previous chemotherapic treatments for metastatic disease - Central nervous system metastasis - Radiotherapy on single target lesion (palliative radiotherapy is allowed on non-target lesions or on non-single target lesion with bone marrow irradiation less than 25%) - Female patients who are pregnant or nursing - History of any other active malignancy during the last 3 yrs except non-melanoma skin cancer, in situ cervical carcinoma, or radically treated early prostate cancer - Any acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or drug administration or could interfere with the interpretation of study results (i.e: acute myocardial infarction, unstable angina, congestive heart failure, serious uncontrolled cardiac arrhythmia, active infection, uncontrolled hypertension or diabetes, etc). - Inability to comply with scheduled visits, therapy plans or laboratory tests Current enrollment in another therapeutic clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Overall response rate (ORR) and clinical benefit (CB) - Safety;Secondary Objective: - Progression-free survival (PFS) - Overall survival (OS) - Quality of life (QoL) - Analysis of serum angiogenic factors variation and evaluation of changes in cell populations involved in angiogenic process;Primary end point(s): Overall response rate (ORR) and clinical benefit (CB) Safety | — |
Countries
Italy
Outcome results
None listed