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A Phase 2, Multicenter, Open-Label, 2-Cohort Study Of Trastuzumab Deruxtecan (DS-8201a), An Anti-HER2 Antibody Drug Conjugate (ADC), For HER2-Over-Expressing Or -Mutated, Unresectable And/Or Metastatic Non-Small Cell Lung Cancer (NSCLC)
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-over-expressing and/or HER2-mutated advanced NSCLC subjects.
Primary Objective: The primary objective is to evaluate the objective response rate (ORR) of trastuzumab deruxtecan in HER2-overexpressing and/or HER2 mutated advanced NSCLC subjects. The secondary objectives are: To evaluate duration of response (DoR),disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) To further evaluate the safety of trastuzumab deruxtecan To determine the pharmacokinetics (PK) of trastuzumab deruxtecan
Trastuzumab Deruxtecan ()