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
Male and female participants must be at least 18 years of age at the time of signing the ICF.
Histologically documented Stage III locally advanced and unresectable non-squamous NSCLC not amenable to curative surgery or radiation and/or Stage IV NSCLC.
Participants must have HER2 overexpression (IHC 3+).
progressed following at least one or two prior systemic treatment.
Has spinal cord compression or clinically active central nervous system metastases.
Corrected QT interval (QTcF) prolongation to > 470 msec (females) or >450 msec (males) based on average of the screening triplicate12-lead ECG.
History of (non-infectious) ILD / pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals
Single group
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
To assess the efficacy of T-DXd by evaluation of Progression-free survival
Endpoints based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) • Progression-free survival (PFS)
To assess the Overall survival (OS) of T-DXd
To assess the Overall survival (OS) of T-DXd
To assess the Objective response rate (ORR) of T-DXd
To assess the Objective response rate (ORR) of T-DXd based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
To assess the Disease control rate (DCR) of T-DXd
To assess the Disease control rate (DCR) of T-DXd
Safety and toxicity
Adverse events/serious adverse events (AEs/SAEs)
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This trial is not recruiting at the moment. You can still explore other options:
