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Secondary outcomes are the overall survival rates, clinical responses, tumor size reductions, health-related qualities of life, and safety. The result of this clinical trial will provide evidence for the efficacy and safety of using HAD-B1 in the treatment of EGFR-positive patients with locally advanced or metastatic NSCLC who require afatinib therapy. Clinical Research Information Service (CRIS), Republic of Korea (ID KCT0005414), on September 23, 2020. Clinical Research Information Service (CRIS), Republic of Korea (ID KCT0005414), on September 23, 2020.