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Objective: To evaluate the clinical effects and toxicity of concurrent chemoradiotherapy combined with Kanglaite injection in the treatment of regionally advanced unresectable non-small cell lung cancer. Methods: 48 patients with regionally advanced unresectable non-small cell lung cancer were randomized to two groups, 25 patients in the combination group (concurrent chemoradiotherapy + Kanglaite) and 23 patients in the control group (concurrent chemoradiotherapy).The combination group received chemotherapy of vinorelbine (NVB) plus cisplatin (DDP) regimen, radiotherapy was given with conventional fraction in 2 Gy per fraction and five fractions per week concurrently. The total tumor doses were 56-60Gy. Combined with Kanglaite injection 200 mL/d for twenty-one days for two courses in the combination group, the control group was chemoradiotherapy only. Effects and toxicities were evaluated according to the criteria of WHO. Results: The CR rates in the combination group and control group were 24.0% (6/25) and 13.0% (3/23), respectively (P ＞ 0.05). Response (CR + PR) rates of combination group were 76.0 % (19/25) and 69.6% (16/23) in control group, P ＞ 0.05. The incidence rates of grades 3-4 leukocytopenia, grades 3-4 digestive system (nausea and vomiting) and grades 3-4 esophagitis in the combination group and control group were 40.0% (10/25), 8.0% (2/25), 16.0% (4/25) and 69.6% (16/23), 34.8% (8/23), 43.5%(10/23), respectively (P ＜ 0.05). KPS and body weight score significantly increased in combination group after the combined treatment, P ＜ 0.05. Conclusion: Concurrent chemoradiotherapy combined with Kanglaite injection can relieve side effects of chemoradiotherapy in the treatment of regionally advanced unresectable non-small cell lung cancer, and improve quality of life. Kanglaite injection may increase effective rate of regionally advanced unresectable non-small cell lung cancer combined with concurrent chemoradiotherapy.