The trial consists of two stages: efficacy exploration and efficacy verification.~At the first stage, at most 30 patients will be enrolled for each of the two cohorts as defined by HER2 mutation sites. If ≥8 patients achieved objective response, the second stage will be continued; otherwise the trial will be terminated. Approximately 40 patients will be enrolled in the second stage.
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-mutated unresectable or metastatic non-small-cell lung cancer (NSCLC).