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

Samsung Medical Center

Status: Not yet enrolling

Conditions: EGFR T790M; Metastatic Lung Non-Small Cell Carcinoma

Treatments: Drug: Lazertinib

Study type: Observational

Funder types: Other

Identifiers

NCT05377788

KCSG LU22-01

Details and patient eligibility

About

• 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

Full 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

Enrollment: 900 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

900 participants in 2 patient groups

Prospective cohort

Description:

* Inclusion criteria * 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 * After obtaining a consent form for research participation, follow-up and monitoring survival information and safety information. Survival follow-up of prospective cohorts will be followed up to the point of first occurrence during disease progression, withdrawal of consent, failure of follow-up investigation, and death.

Treatment:

Drug: Lazertinib

Restrospective cohort

Description:

* Inclusion criteria * adults over the age of 19 * Patients who are already using the lazertinib according to the domestic authorization of lazertinib(This includes when participants receive interventions as part of routine medical care) * Survival information is monitored after the time when the consent form for participation in the study is obtained. Survival follow-up of retrospective cohorts will be followed up to the point of first occurrence during disease progression, withdrawal of consent, failure of follow-up investigation, and death

Treatment:

Drug: Lazertinib