Randomized phase II study of continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in previously untreated non-small cell lung cancer (NSCLC) with sensitive EGFR mutations (NEJ005/TCOG0902)

INTERVENTION: Continuous gefitinib plus chemotherapy (Carboplatin + Pemetrexed) Alternation of gefitinib and chemotherapy (Carboplatin + Pemetrexed) CONDITION: Non‐small cell lung cancer with EGFR mutations (non‐squamous histology) PRIMARY OUTCOME: Progression‐free survival SECONDARY OUTCOME: Response rate, overall survival, and safety INCLUSION CRITERIA: 1) Histologically or cytologically proven NSCLC (non‐squamous histology) 2) Stage IIIB, IV, or relapsed NSCLC 3) NSCLC harboring sensitive EGFR mutations 4) At least one measurable lesion 5) Chemotherapy‐naive patients 6) Over 20 years old and under 75 years old 7) ECOG performance status of 0‐1 8) Adequate organ functions (WBC >= 4,000 /mm3, Neutrophil >= 2,000 /mm3, Platelet >= 100,000 /mm3, Hemoglobin concentration >= 9.0 g/dl, AST or ALT <= twice the number of ULN, T‐bilirubin <= 1.5 mg/dl, Cr <= 1.5 mg/dl, PaO2 or SpO2 >= 60 Torr or 95%) 9) Life expectancy of at least 3 months 10) Written informed consent