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

NCT05377788 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2022-05-19

No results posted yet for this study

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

Conditions

  • Metastatic Lung Non-Small Cell Carcinoma
  • EGFR T790M

Interventions

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

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Jin Seok Ahn, MD, PhD · Samsung Medical Center

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05377788 on ClinicalTrials.gov