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

Sponsor
Samsung Medical Center
Study ID
NCT05377788
Status
Unknown

Conditions

  • EGFR T790M
  • Metastatic Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

* 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

Key Dates

Start date
Jul 31, 2022
Status verified
May 2022
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
900 participants (estimated)

Arms

  • Arm: Prospective cohort
    * 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.
  • Arm: Restrospective cohort
    * 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

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Through study completion, an average of 3 years ]

Central Contacts

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