Spots Global Cancer Trial Database for A Study of MRG002 in the Treatment of Patients With HER2-mutated Unresectable/Metastatic Non-small Cell Lung Cancer (NSCLC).

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Trial Identification

Brief Title: A Study of MRG002 in the Treatment of Patients With HER2-mutated Unresectable/Metastatic Non-small Cell Lung Cancer (NSCLC).

Official Title: An Open-label, Multi-center, Non-randomized Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in Patients With HER2-mutated Unresectable/Metastatic Non-small Cell Lung Cancer (NSCLC).

Study ID: NCT05141786

Conditions

Non-small- Cell Lung Cancer (NSCLC)

Interventions

MRG002

Study Description

Brief Summary: 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).

Detailed Description: 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.