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Backgmund:Patients with non-small cell lung cancer with epidermal growth factor receptor(EGFR) gene mutation respond well to the EGFR tyrosine kinase inhibitor gefitinib.Traditional Chinese medicine(TCM) is used as complementary and alternative therapy for cancer patients in South China.The purpose of this study is to determine if "Fuzheng Kangai(FZKA,a traditional Chinese herbal medicine)" decoction plus gefitinib have longer progression-free survival and with less toxicity than gefitinib alone.Methods:We conducted a randomized,controlled trial with recruitment between January 1,2009,and February 28,2012,in South China.60 chemotherapy-naive patients diagnosed with stage ⅢB/Ⅳ non-small cell lung cancer with EGFR mutations(either the exon 19 deletion or L858R point mutation) were randomly assigned to receive either gefitinib plus FZKA(G,250 mg/day orally;F,250ml/bid/day orally;n=30) or gefitinib(G,250 mg/day orally;n=30) alone.The primary endpoint was Pmgression-free survival(PFS),second endpoints were median survival time(MST),objective responserate(ORR),disease control rate(DCR) and safety.Results:No patient was excluded after randomization.Thus,60 patients(30 in each group) were included in the survival analyses.The GF group hadsignificantly longer PFS and MST compared with the G group,with a median PFS of 10.2 months(95％CI 8.6-12.0) versus 7.9 months(95％ CI 6.2-9.6,log-rank P<0.05),MST of 16.8 months(95％ CI14.1-19.5) versus 13.2 months(95％ CI 10.5-15.9,log-rank P<0.05).The ORR and DCR in GF groupwere 66.7％,93.3％,and in G group were 60.0％,83.3％(P>0.05).The most common adverseevents in the GF groupwere rash or acne(in 43.3％ of patients) and diarrhea(13.3％),and in the G group,rash or acne (in 56.7％ of patients),diarrhea(36.7％),andstomatitis(3.3％)(P<0.05).Conclusions Patients with advanced non-small celllung cancer who are selected by EGFR mutations have longer progression-free survival,median survival time and with less toxicity if they are treated with gefitinib plus FZKA than if they are treated with gefitinib alone.