Lazertinib 160mg in EGFR T790M NSCLC

Samsung Medical Center117 enrolled

Overview

The lazertinib is currently approved as 2nd line T790M mutation-positive NSCLC that failed from either 1st or 2nd generation EGFR TKI. The current recommended dosage is 240mg. Based on the promising clinical efficacy of the dose escalation study, this study is designed to evaluatee the clinical efficacy and safety of 160mg lazertinib.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

117

Conditions

Lung Cancer Stage IV EGFR T790M

Interventions

LazertinibDRUG

160mg po qd

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologically confirmed non-small cell lung cancer * Patients in a palliative setting who is not applicable for the curative treatment * EGFR mutation positive patients who received previous 1st or 2nd generation EGFR TKI * Confirmed EGFR T790M mutation after the previous EGFR TKI * Available to receive lazertinib either as po or vis levine tube * Willing to participate clinical trial * Age over or equal to 19 * ECOG PS 0 to 2 Exclusion Criteria: * Previously received 3rd generation EGFR TKI * No clinical benefit is expected based on the investigator's decision * Uncontrolled symptomatic CNS metastases * Uncontrolled systemic disease

Locations (1)

Samsung Medical Center

Seoul, MA, South Korea

Outcomes

Primary Outcomes

The dose reduction or treatment discontinuation rate

Dose who received dosage below 160mg or discontinued due to the adverse event

Time frame: Total 24 months of study period

Data from ClinicalTrials.gov

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