BENITIONSClinical Trial Intelligence

A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)

1/2期 进行中(已停止招募) NCT05460273

适应症Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Cancer
分期1/2期
申办方AstraZeneca
状态进行中(已停止招募)
受试者人数119 人
干预(药物)Datopotamab Deruxtecan (Dato-DXd)
开始日期2022年7月11日
完成日期2023年11月7日
结果公布日2025年6月13日

摘要

Researchers are looking for a better way to treat advanced Triple-Negative Breast Cancer (TNBC) and Non-Small-Cell Lung Cancer (NSCLC). "Advanced" usually means that the cancer keeps growing even with treatment. The cancer may also be "metastatic", which means that it has spread to other parts of the body or the surrounding tissue. The study drug, Datopotamab deruxtecan, is designed to work by attaching to the tumor cells and stopping the tumor growth. Datopotamab deruxtecan is also known as Dato-DXd. In this study, the researchers want to find out how well Dato-DXd works to stop tumors from growing in Chinese participants with NCSLC or TNBC. This is the first time Dato-DXd is being studied in Chinese population. Participants in this study will get Dato-DXd through a needle as an injection. They will get 1 dose of Dato-DXd every 3 weeks until their cancer gets worse or they leave the study for another reason. Participants will visit their study sites at least once every 3 weeks for as long as they are in the study. The study doctors will take blood samples every 3 weeks and take images of the participants' tumors every 6 weeks until the participant leaves the study.

Confirmed Objective Response Rate(ORR) Assessed by Independent Central Review(ICR)

TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up. · Percentage of participants

TNBC Cohort33.8 Percentage of participants
NSCLC Cohort45.0 Percentage of participants

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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。