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.
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.
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.
NSCLC patients with HER2 mutations who receive T-DXd based on physicians' discretion will be enrolled from about 30 sites in China.
Cohort
Prospective
No drug
Other interventionThis 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.
Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS)
rwPFS is defined as the time from the initiated date of ≥ second-line treatment of T-DXd until disease progression or death by investigator report as recorded in the electronic case report forms (eCRF).
Time to Treatment Discontinuation or Death (TTD)
TTD is defined as the time from the initiated date of ≥ second-line treatment of T-DXd to the date of treatment discontinuation or death from any cause.
Best Overall Response Rate (BORR)
BORR is defined as the percentage of patients with complete response (CR) or partial response (PR) as assessed by investigator for ≥ second-line treatment of T-DXd. Based on RECIST guidelines, CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Overall Survival
Overall survival is defined as the time from the initiated date of ≥ second-line treatment of T-DXd until death due to any cause.
Number of Patients Reporting Treatment-related Adverse Events (TRAEs), Adverse Events of Special Interests (AESIs), and AEs Leading to Dose Interruption, Reduction, Discontinuation
TRAEs, AESIs and AEs leading to dose interruption, reduction, discontinuation will be graded by the investigators using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 and coded using the medical dictionary for regulatory activities (MedDRA).
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