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A Phase 2, Multicenter, Randomized Study of Trastuzumab Deruxtecan in Subjects with HER2-mutated Metastatic Non-Small Cell Lung Cancer (NSCLC) [DESTINY-Lung02]
This study was designed to evaluate the safety and efficacy of trastuzumab deruxtecan in HER2-mutated metastatic non-small cell lung cancer (NSCLC) participants who had disease recurrence or progression during/after at least one regimen of prior anticancer therapy (second line or later) that must have contained a platinum-based chemotherapy drug.
Primary Objectives To evaluate confirmed ORR of trastuzumab deruxtecan in HER2-mutated NSCLC subjects treated at 5.4 and 6.4 mg/kg doses. Secondary Objectives: To evaluate the clinical efficacy of trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses by confirmed ORR by investigator assessment. To evaluate the clinical efficacy of trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses by DoR. To evaluate further the clinical efficacy of trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses by DCR, Progression-free survival (PFS) and Overall survival (OS). To evaluate safety of trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses. To evaluate pharmacokinetics (PK) and immunogenicity of trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses. To assess symptoms, functioning and Healthrelated Quality of life (HRQoL) in subjects treated with trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses. To evaluate time to response (TTR) and best percent change in the sum of the diameters for all target lesions. To assess associations between biomarker status and efficacy and/or safety. To explore or assess: o Symptoms functioning and HRQoL with newly recommended NSCLC-SAQ. o The impact of treatment and disease state on health utility using the EQ-5D-5L. o Patient reported treatment tolerability. o The subject s overall impression of the severity of their cancer symptoms, change in condition since starting the study o The impact of treatment and disease on health care resource use.
DS-8201a (Trastuzumab Deruxtecan); Trastuzumab Deruxtecan ()
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