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760 Interim analysis after 340 deaths: HR of death 1.40 in experimental arm (P=0.002); OS 10.8 mos (standard arm) vs. 7.7 mos (experimental arm) 7 Unselected, stage IIIB/IV Erlotinib followed at progression by Cisplatin-Gemcitabine (experimental arm) vs. CisplatinGemcitabine followed at progression by Erlotinib (standard arm) Cisplatin-Gemcitabine ± Gefitinib 1,093 8 INTACT-2 Unselected, stage IIIB/IV Carboplatin-Paclitaxel ± Gefitinib 1,037 IPASS East Asian, nonor former light smoker, stage IIIB/IV, adenoca Stage IIIB/IV, EGFR mutant in Japan Korean, neversmoker, stage IIIB/IV Stage IIIB/IV, EGFR mutant in Japan Gefitinib vs. Carboplatin-Paclitaxel 1,217 OS 9.9 mos (gefitinib 500 mg/d) vs. 9.9 mos (Gefitinib 250 mg/d) vs. 10.9 mos (placebo) (P=0.46) OS 8.7 mos (gefitinib 500 mg/d) vs. 9.8 mos (gefitinib 250 mg/d) vs. 9.9 mos (placebo) (P=0.64) PFS: 12-mo PFS rate 24.9% (gefitinib) vs. 6.7% (chemo) (P<0.001) Gefitinib vs. Cisplatin-Docetaxel 172 PFS 9.2 mos (Gefitinib) vs. 6.3 mos (chemo) (P<0.001) 11 Gefitinib vs. CisplatinGemcitabine 313 OS 20.3 mos (Gefitinib) vs. 23.1 mos (chemo) (P=0.43) 12 Gefitinib vs. CarboplatinPaclitaxel 200 13 EGFR+, stage IIIB/IV Unselected, stage IIIB/IV Cisplatin-Vinorelbine ± Cetuximab Carboplatin-Taxane ± Cetuximab 1,125 Unselected, stage IV or recurrent disease after prior surgery and/or irradiation Carboplatin-PaclitaxelBevacizumab ± Cetuximab Enrolling PFS 10.8 mos (gefitinib) vs. 5.4 mos (chemo alone) (P<0.001) [Secondary endpoints: RR 73.7% (Gefitinib) vs. 30.7% (chemo) (P<0.001); OS 30.5 mos (Gefitinib) vs. 23.6 mos (chemo) (P=0.31) OS 11.3 mos (chemo + Cetuximab) vs. 10.1 mos (chemo alone) (P=0.04) PFS 4.4 mos (chemo + Cetuximab) vs. 4.24 mos (chemo alone) (P=0.236) [Secondary endpoint OS 9.69 mos (chemo + Cetuximab) vs. 8.38 mos (chemo alone) (P=0.169) OS and PFS Unselected, stage 4 cycles platinum doublet 889 PFS 12.3 weeks (Erlotinib) vs. 11.1 weeks 16 TORCH Unselected, stage IIIB/IV INTACT-1 WJTOG3405 First-SIGNAL NEJ002 FLEX BMS 099 SWOG NCT00946712 Maintenance â Advanced SATURN EGFR 676 4 9 10 14 15 1