PhaseIII study of gefitinib versus cisplatin plus docetaxel in patients with non-small cell lung cancer with EGFR mutation

INTERVENTION: A: Experimental arm Gefitinib (250mg/day) monotherapy until disease progression B: Reference arm CDDP (80mg/sqm) day1, Docetaxel (60mg/sqm), q3w x 3‐6 courses CONDITION: non small cell lung cancer PRIMARY OUTCOME: Progression free survival SECONDARY OUTCOME: Overall survival; Response INCLUSION CRITERIA: 1.A) Patients with NSCLC who have recurrent disease after surgery with no prior drug therapy for the recurrent disease and who are not candidates for radiotherapy with a curative intent. Those who received postoperative adjuvant chemotherapy other than CDDP+DOC are eligible. OR B) NSCLC patients with stage IIIB or IV disease with no prior treatment who are not candidates for surgical resection or radiotherapy with a curative intent. 2.A case with confirmed EGF‐R genomic mutation (deletion in Exon 19 or codon 858 change of Leucin to Arginine in Exon 21) in the histologic or cytologic specimen in which tumor cells definitely exist. 3.A case of which histologic or cytologic (pleural effusion) specimen is reserved if the case needs to be pre‐registered because of no confirmation of EGF‐R mutation. 4.Patients with evaluable disease (not necessarily to be measurable by RECIST) 5. If the patient underwent pre‐ or postoperative chemotherapy, there should