The Efficacy and Safety of Trastuzumab Deruxtecan in Advanced or Metastatic NSCLC With HER2 Over Expression
- Sponsor
- Hunan Province Tumor Hospital
- Study ID
- NCT07662473
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Experimental Group — DRUGAll participants enrolled in the study will receive the study intervention (T-DXd) 5.4 mg/kg as an IV infusion Q3W, on Day 1 of each 3-week cycle
Study Details
This is a single arm, multicenter and prospective study to evaluate the efficacy and safety of T-DXd for the treatment in locally advanced, unresectable, or metastatic participants with selected HER2 positive (IHC 3+) NSCLC which are not eligible for curative therapy
Key Dates
- First listed
- Jun 23, 2026
- Start date
- Jul 29, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2027
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: T-DXd groupAll participants enrolled in the study will receive the study intervention (T-DXd) 5.4 mg/kg
Primary Outcome Measure
To assess the efficacy of T-DXd by evaluation of Progression-free survival [ Time Frame: UP to approximately 3 years ]
Central Contacts
- Chang Yong Zhang+86 13873123436
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