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 — DRUG
    All 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 group
    All 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

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