* 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
□ 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
Study Type
OBSERVATIONAL
Enrollment
900
Treatment of EGFR T790M mutant-positive local progressive or metastatic non-small cell lung cancer patients who have previously been treated with EGFR
Samsung Medical Center
Seoul, South Korea
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from study enrollment until objective disease progression or death.
Time frame: Through study completion, an average of 3 years
Objective response rate (ORR)
Objective response rate is defined as the proportion of patients who have a partial or complete response to therapy.
Time frame: Through study completion, an average of 3 years
Time to treatment failure (TTF)
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.
Time frame: Through study completion, an average of 3 years
Overall survival (OS)
Overall survival (OS) is defined as the time from treatment to death.
Time frame: Through study completion, an average of 3 years
Duration of response (DoR)
Duration of response (DoR) is the length of time that a tumor continues to respond to treatment without cancer growing or spreading.
Time frame: Through study completion, an average of 3 years
Intracranial Progression-free survival (Intracranial PFS)
Intracranial PFS is defined as the time from study enrollment until objective intracranial progression.
Time frame: Through study completion, an average of 3 years
Relative dose intensity
Relative dose intensity is defined as the actual dose received divided by the standard calculated dose during a predefined period.
Time frame: Through study completion, an average of 3 years
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