NCT05377788

Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 900 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: —

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

Conditions

• Metastatic Lung Non-Small Cell Carcinoma
• EGFR T790M

Interventions

Type	Name	Description
DRUG	Lazertinib	Treatment of EGFR T790M mutant-positive local progressive or metastatic non-small cell lung cancer patients who have previously been treated with EGFR

Timeline

• Start date: 2022-07-31
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2022-05-17
• Last updated: 2022-05-19

Locations

1 site across 1 country: South Korea