Treatment in locally advanced or metastatic non-small-lung cancer.
Conditions
Sponsors
Pierre Fabre Medicament represented by IRPF
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Between 18 years and 75 years - Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer, stage IIIB (with supra-clavicular or nodal metastases or pleural effusion), stage IV or relapsing (locally or distant) after a local treatment - Karnofsky Performance Status not less than 80% - Life expectancy not less than 12 weeks - Previously untreated with chemotherapy or immunotherapy - Adequate bone marrow, hepatic and renal functions - Presence of at least one measurable indicator lesion (RECIST criteria) which has not been previously irradiated. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with a local relapse to be treated by radiation therapy only - Symptomatic neuropathy (sensory) not less than 1 according to the NCI Common Toxicity Criteria - Concomitant/uncontrolled medical disorder (cardiovascular, hepatic or other systemic disease) - Active central nervous disorder, brain metastasis or leptomeningeal involvment - Weight loss not less than 10% within the previous 3 months - Superior vena cava syndrome - Long term oxygen therapy - Pre-existing symptomatic pleural effusion requiring tapping - Ascites or pericardial effusion - Radiotherapy within the previous 4 weeks - Previous radiotherapy in the only site used to assess response - Concomitant treatment with any other anticancer drug - Known hypersensitivity to drugs with similar chemical structures of study drugs - Concomitant treatment with corticosteroids except chronic treatment lasting more than 1 month, given at low doses (not less than 20mg/day of methylprednisolone or equivalent) - Significant malabsorption syndrome or disease affecting the gastro-intestinal tract function - Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare time to Treatment Failure (TTF) for both regimens;Secondary Objective: To evaluate the response rate, the progression free survival and overall survival in both arms. To evaluate the tolerance in both arms. To assess clinical benefit and to evaluate QOL using LCSS in both arms.;Primary end point(s): Comparative evaluation of the Time to Treatment Failure (TTF) for both regimens. | — |
Countries
Estonia
Outcome results
None listed