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

NCT04248829 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2024-12-03

Study results available
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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

Conditions

Interventions

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

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2022-07-29
Completion
2026-06-30
FDA Drug
Yes

Countries

  • Australia
  • Greece
  • Hungary
  • Malaysia
  • Philippines
  • Russia
  • Serbia
  • Singapore
  • South Korea
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

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 NCT04248829 on ClinicalTrials.gov