BENITIONSClinical Trial Intelligence

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

3期 进行中(已停止招募) NCT04656652

适应症Non-small Cell Lung Cancer
分期3期
申办方Daiichi Sankyo
状态进行中(已停止招募)
受试者人数605 人
干预(药物)DS-1062a, Docetaxel
开始日期2020年12月21日
完成日期2024年5月10日
结果公布日2025年7月23日

摘要

This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.

Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel

From randomization until disease progression or death (whichever occurs first), up to approximately 27 months · months

DS-1062a 6.0 mg/kg4.4 months
Docetaxel 75 mg/m^23.7 months

Overall Survival (OS) Following DS-1062a Versus Docetaxel

From randomization until date of death due to any cause, up to to approximately 38 months · months

DS-1062a 6.0 mg/kg12.9 ± 11.0 months
Docetaxel 75 mg/m^211.8 ± 10.1 months

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。