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 |
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| 分期 | 3期 |
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| 申办方 | Daiichi Sankyo |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 605 人 |
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| 干预(药物) | DS-1062a, Docetaxel |
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| 开始日期 | 2020年12月21日 |
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| 完成日期 | 2024年5月10日 |
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| 结果公布日 | 2025年7月23日 |
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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/kg | 4.4 months |
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| Docetaxel 75 mg/m^2 | 3.7 months |
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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/kg | 12.9 ± 11.0 months |
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| Docetaxel 75 mg/m^2 | 11.8 ± 10.1 months |
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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。