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Abstract: Purpose: To compare the efficacy and toxicities of chemotherapy plus cetuximab (Erbitux, E; E-chemo) with chemotherapy alone (chemo alone) in patients with previously untreated advanced non-small-cell lung cancer (NSCLC). The primary endpoint was overall survival; the secondary endpoints were progression-free survival, overall response rate, one-year survival and safety. Methods: The PubMed database, the Cochrane Library, conference proceedings, database of ongoing trials and references of published trials and reviews were screened. Two reviewers independently assessed the quality of the trials and extracted data. The hazard ratios (HRs) for overall survival and progression-free survival, relative risks (RRs) for overall response rate and one-year survival, and odds ratios (ORs) for the different types of toxicity were pooled using STATA SE10.1 package. Results: Four trials involving 2018 patients with previously untreated NSCLC were ultimately analyzed. The pooled HR for overall survival (HR, 0.87; 95%CI, 0.79–0.96; p =0.004) was in favor of E-chemo, which also gave rise to a higher overall response rate (RR, 1.19; 95%CI, 1.04–1.37; p =0.013). The analysis failed to show benefit of E-chemo in progression-free survival (HR, 0.91; 95%CI, 0.83–1.00; p =0.06) and one-year survival (RR, 1.10; 95%CI, 0.98–1.26; p =0.172). E-chemo indeed caused more grade 3/4 rash and infusion reaction (OR, 43.86; 95%CI, 12.46–154.44; p =0.000; OR, 3.69; 95%CI, 1.89–7.25; p =0.000; respectively). Conclusion: Our data showed that the addition of cetuximab to chemotherapy would improve overall survival and overall response rate. It may provide new option for clinical treatment for untreated advanced non-small-cell lung cancer. The side effects of E-chemo are predictable and manageable. [ABSTRACT FROM AUTHOR]