NCT04248829

Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)

A Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Lazertinib Versus Gefitinib as the First-line Treatment in Patients With Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 393 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations

Detailed description

YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) that targets both the T790M mutation and activating EGFR mutations while sparing wild type EGFR. This is a Phase III, Randomized, Double-blind study evaluating the efficacy and safety of YH25448 (240 mg orally, once daily) versus Gefitinib (250 mg orally, once daily) in patients with locally advanced or metastatic NSCLC that is known to be EGFR sensitizing mutation (EGFRm) positive, treatment-naïve and eligible for first-line treatment with an EGFR-TKI.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Lazertinib 240 mg/160 mg	The initial dose of lazertinib 240 mg (3 tablets of 80 mg lazertinib) once daily can be reduced to 160 mg once daily (2 tablets of 80 mg lazertinib) under specific circumstances
DRUG	Gefitinib 250 mg	The initial dose for Gefitinib (250 mg once daily) cannot be reduced to a lower dose
DRUG	Lazertinib-matching placebo 240 mg/160 mg	The initial dose of lazertinib-matching placebo 240 mg (3 tablets of 80 mg lazertinib-matching placebo) once daily can be reduced to 160 mg once daily (2 tablets of 80 mg lazertinib-matching placebo) under specific circumstances
DRUG	Gefitinib-matching placebo 250 mg	The initial dose for Gefitinib-matching placebo (250 mg once daily) cannot be reduced to a lower dose

Timeline

• Start date: 2020-02-13
• Primary completion: 2022-07-29
• Completion: 2026-06-01
• First posted: 2020-01-30
• Last updated: 2024-12-03
• Results posted: 2024-03-22

Locations

80 sites across 13 countries: Australia, Greece, Hungary, Malaysia, Philippines, Russia, Serbia, Singapore, South Korea, Taiwan, Thailand, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study