IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer

Inclusion Criteria

• •Histologically documented NSCLC (tumor tissue samples will be provided to look for assessment of EGFR status with CISH, immunochemistry and mutations) : adenocarcinoma, squamous cell carcinoma, large cell carcinoma. A cytological documentation of NSCLC is accepted.
• •Stage IV disease or metastatic relapse in not previously irradiated areas of a NSCLC previously treated with surgery or radiation therapy (with a histologically documented proof of relapse) or stage III B with documented pleural involvement.
• •Measurable disease according to the RECIST criteria.
• •Prior radiotherapy authorized except for irradiation concerning measurable disease.
• •Age \>18 and \< 70 years.
• •PS \< 2.
• •Normal hepatic function : serum bilirubin \< 1.5 ULN, SGOT (ASAT) and SGPT (ALAT) \< 2,5 ULN ; in presence of liver metastases, SGOT and SGPT must be \< 5 x ULN.
• •Creatinine clearance \> 60 mL/min.
• •Granulocyte count \> 1,5 giga/L, platelet count \> 100 giga/L.
• •Life expectancy \> 12 weeks.
• •Written (signed) informed consent for use of tumors samples.
• •Written (signed) informed consent to participate in the sudy.