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Efficacy and Safety of T-DXd in HER2-mutant Advanced Lung Cancer Patients With Asymptomatic Brain Metastases
Study Purpose
'1. Objective.
- - Primary objective.
- - Median Intracranial Progression-free survival(icPFS) as defined by RANO(Response Assessment in Neuro-Oncology) criteria.
- - Secondary objective.
- - Progression free survival(PFS) as defined by RECIST 1.1.
- - Median Intracranial progression free survival(icPFS) as defined by RECIST 1.1.
- - Intracranial objective response rate(icORR) as defined by RECIST 1.1.
- - Overall response rate(ORR) as defined by RECIST 1.1.
- - Duration of response(DoR) as defined by RECIST 1.1.
- - Disease control rate (DCR) defined by RECIST 1.1.
- - Overall survival (OS) ; The time from the date of inital IP administration to death due to any cause.
- - Pattern of Progression ; Site of next progression.
- - Safety objective.
- - To evaluate the safety and tolerability of Trastuzumab deruxtecan.
- - To identify mechanisms of adaptive resistance using Guardant 360 panel.
- - To identify the profiling of interstitial lung disease (ILD) after treatment of T-DXd.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 20 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06250777 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Yonsei University |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Hye Ryun Kim |
Principal Investigator Affiliation | Yonsei University Health system, Severance Hospital |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Not yet recruiting |
Countries | Korea, Republic of |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Non Small Cell Lung Cancer |
Contact a Trial Team
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