Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III Non-small Cell Lung Cancer (NSCLC)

This study include a multicenter, randomized, controlled, double-blind, placebo-controlled post-market clinical trial and a registration study. The randomized clinical trial included subjects (n =798) will be randomly divided into experimental (n = 532) and control groups (n =266) according to a random number table. Patients in the experimental group will receive Huaier Granule (20g/time, 3 times/d). Patients in the control group will receive placebo (20g/time, 3 times/d). The registration study plan to recruitment at least 300 patients. The primary outcome measures is disease-free survival，secondary outcome measures is 2-year overall survivals, ECOG-performance status, Karnofsky performance score and tumor markers (CEA、CYFRA21-1、SCC).