This randomized, phase 3 trial evaluated the efficacy and safety of adjuvant vinorelbine plus cisplatin compared to observation in patients with completely resected early-stage non-small-cell lung cancer (NSCLC). The primary endpoint was overall survival, with secondary endpoints including recurrence-free survival and toxicity. A total of 482 patients were randomly assigned to receive either vinorelbine plus cisplatin or observation. The median age was 61 years, and 65% were men. Chemotherapy caused neutropenia in 88% of patients, with two deaths (0.8%) due to toxic effects. Non-hematologic toxic effects included fatigue, nausea, anorexia, vomiting, neuropathy, and constipation, but severe effects were uncommon. Overall survival was significantly prolonged in the chemotherapy group (94 vs. 73 months; hazard ratio for death, 0.69; P=0.04), as was relapse-free survival (not reached vs. 46.7 months; hazard ratio for recurrence, 0.60; P<0.001). Five-year survival rates were 69% and 54% for the chemotherapy and observation groups, respectively (P=0.03). The study concluded that adjuvant vinorelbine plus cisplatin has an acceptable level of toxicity and prolongs disease-free and overall survival in patients with completely resected early-stage NSCLC.This randomized, phase 3 trial evaluated the efficacy and safety of adjuvant vinorelbine plus cisplatin compared to observation in patients with completely resected early-stage non-small-cell lung cancer (NSCLC). The primary endpoint was overall survival, with secondary endpoints including recurrence-free survival and toxicity. A total of 482 patients were randomly assigned to receive either vinorelbine plus cisplatin or observation. The median age was 61 years, and 65% were men. Chemotherapy caused neutropenia in 88% of patients, with two deaths (0.8%) due to toxic effects. Non-hematologic toxic effects included fatigue, nausea, anorexia, vomiting, neuropathy, and constipation, but severe effects were uncommon. Overall survival was significantly prolonged in the chemotherapy group (94 vs. 73 months; hazard ratio for death, 0.69; P=0.04), as was relapse-free survival (not reached vs. 46.7 months; hazard ratio for recurrence, 0.60; P<0.001). Five-year survival rates were 69% and 54% for the chemotherapy and observation groups, respectively (P=0.03). The study concluded that adjuvant vinorelbine plus cisplatin has an acceptable level of toxicity and prolongs disease-free and overall survival in patients with completely resected early-stage NSCLC.