Non-small Cell Lung Cancer
Conditions
Keywords
Locally advanced or metastatic NSCLC, HER2 mutations, T-DXd
Brief summary
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.
Detailed 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.
Interventions
OTHERNo drug
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.
Sponsors
Daiichi Sankyo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The key inclusion criteria for this study are: 1. Age ≥18 years at signing informed consent form (ICF). 2. Pathologically documented unresectable and/or metastatic non-squamous NSCLC. 3. Documented any known activating HER2 mutation. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 5. 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: 1. 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 2. 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. 3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS) | Baseline up to approximatley 2 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Discontinuation or Death (TTD) | Baseline up to approximately 2 years | 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) | Baseline up to approximately 2 years | 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 | Baseline up to approximately 2 years | 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 | Baseline up to approximately 2 years | 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). |
Countries
China
Contacts
CONTACTContact for Clinical Trial Information
STUDY_DIRECTORProject Manager
Daiichi Sankyo Co., Ltd.
Outcome results
None listed