EGFR T790M, Metastatic Lung Non-Small Cell Carcinoma
Conditions
Brief summary
* It is to evaluate the safety and effectiveness of a lasertinib(LECLAZA) single drug in a actual medical environment for patients 1. Primary Purpose: Progression-free survival (PFS) 2. Secondary Purpose: * Objective response rate * Time to treatment failure * Adverse event (AE), serious adverse event (SAE), and adverse event of special interest (AESI) * Severity of (S)AE * duration of response (DoR) * Overall survival (OS) * Intravenous Progressive Survival Period (Intracranial PFS) * Relative dose intensity * Research Design : a Multi-Center Prospective and Restrospective Cohort Study
Detailed description
□ the purpose of the study The study aims to explore the safety, efficacy and resistance of test drugs in patients with local progressive or metastatic epithelial growth factor T790M mutant non-small cell lung cancer who have been treated with epithelial growth factor receptor tyrosine kinase inhibitors. This study is conducted in Korea. About 600 patients will be monitored until the first occurrence of disease progression, withdrawal of consent, failure of follow-up investigation, and death. □ Research Procedures and Information Gathering Items There are no additional procedures performed by participating in this study and information on safety and effectiveness during the administration of Rexhraza will be followed up in routine care situations. The information you will receive when you participate in this study is as follows. * Subject characteristics, including age, gender, and race * T790M Positive Mutation Status Results and Types of Tests Performed and Receptors * a related medical history * a physical examination * disease characteristics * history of chemotherapy * associated concomitant medications * administration of a test drug * Safety and effectiveness * Resistance mechanism in plasma circulation tumor DNA
Interventions
DRUGLazertinib
Treatment of EGFR T790M mutant-positive local progressive or metastatic non-small cell lung cancer patients who have previously been treated with EGFR
Sponsors
Samsung Medical Center
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Inclusion criteria
1. Prospective cohort * adults over the age of 19 * Easter Cooperative Oncology Group performance 0-4 * Patients who are eligible for or are being treated for test medication as per permit: patients with NSCLC with local progressive or metastatic EGFR T790M mutation who have previously been treated with Generation 1 or Generation 2 EGFR TKI * EGFR T790M mutation allows for all results identified in tumor tissue or plasma * Patients with brain MR within 3 months of study participation 2. Rectrospective cohort * adults over the age of 19 * Patients who are already using the test drug according to the domestic authorization of the test drug
Exclusion criteria
* Patients who have a history of hypersensitivity to test drugs or drugs of similar chemical structure or similar family to those of test drugs * Pregnant women or lactating women * Patients participating in other interventional clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Through study completion, an average of 3 years | Progression-free survival (PFS) is defined as the time from study enrollment until objective disease progression or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative dose intensity | Through study completion, an average of 3 years | Relative dose intensity is defined as the actual dose received divided by the standard calculated dose during a predefined period. |
| Objective response rate (ORR) | Through study completion, an average of 3 years | Objective response rate is defined as the proportion of patients who have a partial or complete response to therapy. |
| Time to treatment failure (TTF) | Through study completion, an average of 3 years | Time to treatment failure (TTF) is defined as the interval between initiating therapy and the earliest of clinical progression, new locally directed or systemic treatment other than lazertinib. |
| Overall survival (OS) | Through study completion, an average of 3 years | Overall survival (OS) is defined as the time from treatment to death. |
| Duration of response (DoR) | Through study completion, an average of 3 years | Duration of response (DoR) is the length of time that a tumor continues to respond to treatment without cancer growing or spreading. |
| Intracranial Progression-free survival (Intracranial PFS) | Through study completion, an average of 3 years | Intracranial PFS is defined as the time from study enrollment until objective intracranial progression. |
Countries
South Korea
Contacts
Primary ContactShinkyo Yoon, MD
Outcome results
None listed