【Abstract】 Objective To evaluate the effectiveness and safety of concomitant or adjuvant TMZ with WBRT in the management of nonsmall cell lung cancer patients with brain metastases. Methods All of the randomized controlled trials comparing whole brain radiotherapy plus temozolomide with whole brain radiotherapy alone were searched from the following databases: PubMed, EMBASE, Cochrane Library, CNKI, WANFANG, and Chinese Biomedical Literature Database. Search result was screened according to the inclusive and exclusive criteria. The date extraction and quality assessment of eligible RCTs were conducted by two reviewers independently according to Cochrane reviewer′s handbook 51 and the Cochrane collaboration′ s tool for assessing risk of bias. The RevMan 53 software was used for metaanalysis. Results 6 eligible RCTs involving 427 patients were included. 2 trials indicated the method of random sequence generation, and 1 study was an open label, multicentric RCTs. All other trials did not mention the method of randomization, allocation concealment and blinding. Metaanalysis showed that TMZ plus WBRT made a potential benefit for patients with brain metastasis from NSCLC. The objective response rate of WBRT+TMZ group was superior to that of WBRT group (626% vs 460%), and the difference between two groups was significantly different (P = 0.0004). The RR and 95% CI were 141 (117, 171). Regretfully, the combined therapeutic model did not make any difference in over survival and progressfree survival. The P value, HR and 95%CI were 060, 109 (080, 148) and 059, 115(073, 180), respectively. The incidence of Ⅲ/Ⅳgrade hematological toxicity of TMZ+ WBRT group was much higher than that of WBRT group (P=002, RR=214, CI［112,406］). The gastrointestinal symptoms in WBRT+TMZ group were also higher than that in WBRT group, but there was no statistical difference between two groups (P=006, RR=184, CI［098, 347］). Three trials reported symptom of headache, and the incidence was observed frequently in the combined group than in the control group. However, the difference between two groups with no significant statistical meaning (P=066, RR=113, CI［067, 189］). Conclusion Existing evidence suggested that the combined therapeutic model of TMZ plus WBRT improved the objective response rate, but no survival benefit achieved for the patients with brain metastasis from NSCLC. Meanwhile, the Ⅲ/Ⅳgrade hematological toxicity and gastrointestinal symptom rate were increased. In view of the defect, such as small scale and low quality of the included studies, this conclusion need to be further proved with more highquality, largescale, and doubleblind RCTs.