Overview
Trastuzumab deruxtecan (T-DXd) is an approved therapy for non-small cell lung cancer (NSCLC) in China. Despite the clinical trial evidence, there is no real-world data of T-DXd used in Chinese lung cancer patients with HER2 mutations.
This real world, prospective study will assess the effectiveness and safety of T-DXd in patients with locally advanced or metastatic, HER2 mutation-positive NSCLC in real-world setting.
Description
T-DXd is an approved therapy in China for locally advanced or metastatic NSCLC patients with human epidermal growth factor receptor 2 mutations (HER2m). In previous clinical trials, T-DXd demonstrated efficacy and manageable safety profiles in the ≥ second-line setting for NSCLC harboring HER2m. However, patient populations are more diverse in routine practice and no real-world data of T-DXd used in Chinese lung cancer patients with HER2 mutations exist.
This study will assess the effectiveness of ≥ second-line treatment of T-DXd in real-world setting as the primary objective. Secondary objectives will further assess the effectiveness and overall survival of ≥ second-line treatment of T-DXd in real-world setting as well as evaluate the safety and tolerability of any-line treatment of T-DXd in real-world setting. This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on T-DXd will be enrolled in this study.
Eligibility
The key inclusion criteria for this study are:
- Age ≥18 years at signing informed consent form (ICF).
- Pathologically documented unresectable and/or metastatic non-squamous NSCLC.
- Documented any known activating HER2 mutation.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- Patients who receive T-DXd based on physicians' discretion (Newly received or just have started the first dose no longer than 2 months before enrollment).
The key exclusion criteria for this study are:
- Previously treated with HER2-targeted/directed therapies, including:
- tyrosine kinase inhibitors [TKIs] targeting HER2 mutations, except for pan-HER class TKIs.
- an ADC, containing a chemotherapeutic agent targeting topoisomerase I
- Has spinal cord compression or clinically active CNS metastases, defined as
untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.