NCT05463224

Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients

Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients: A Single-arm, Phase II Single-center Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Se-Hoon Lee · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the efficacy/safety of lazertinib and to explore the resistance mechanism of lazertinib as first-line in patients with NSCLC harboring activating EGFR mutations.

Detailed description

As the 3rd generation EGFR TKI become a standard treatment option for the 1st line therapy in EGFR mutated patients, necessity for evaluating resistant mechanism to determine the matched subsequent therapeutic option has been highlighted. The idea of understanding the exact resistance mechanism to 1st line 3rd generation EGFR TKI treatment is emphasized based on the observation that resistance mechanism is different based on osimertinib used as 1st line or 2nd line treatment.6,7 Although resistance mechanisms to lazertinib in patients with prior EGFR TKI treatment have been studied, there are no current data available regarding the resistance mechanism after first-line lazertinib treatment. Based on this observation, PI designed this study to elucidate the efficacy/safety of Lazertinib and to explore resistance mechanisms of 1st line lazertinib treatment in NSCLC patients with activating EGFR mutation.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Lazertinib group	Lazertinib 240mg, Once, po, daily (1 cycle of 21 days)

Timeline

• Start date: 2023-01-02
• Primary completion: 2026-03-31
• Completion: 2026-12-31
• First posted: 2022-07-18
• Last updated: 2025-12-31

Locations

1 site across 1 country: South Korea