Intercalating And Maintenance Use Of Gefitinib Plus Chemotherapy Versus Chemotherapy Alone In Selected Advanced Nsclc(Iscan,Ctong-1102): A Multicentre, Open-Label, Randomised, Phase 3 Study.

8042 Background: This study investigated whether intercalating and maintenance use of gefitinib and chemotherapy improves clinical outcomes versus chemotherapy alone in selected patients with advanced NSCLC after receiving two cycles of chemotherapy with stable disease. Methods: We undertook an open-label, randomized, phase 3 trial at 14 centers in China. We assigned previously untreated patients in China who had stage IIIB or IV pulmonary adenocarcinoma and who were nonsmokers and EGFR mutation status unknown to firstly receive two cycles of gemcitabine plus carboplatin(GC). The patients with stable disease were randomly assigned (1:1) to receive gefitinib on days 15 to 25 of a 4-week cycle of GC or a 4-week cycle of GC alone. In the absence of disease progression, chemotherapy was continued for a maximum of four cycles, after which time patients continued to receive gefitinib or observation until disease progression or unacceptable toxicity. The primary end point was progression-free survival. Secondary...