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

Sponsor
Yuhan Corporation
Study ID
NCT04248829
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lazertinib 240 mg/160 mg — DRUG
    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
  • Gefitinib 250 mg — DRUG
    The initial dose for Gefitinib (250 mg once daily) cannot be reduced to a lower dose
  • Lazertinib-matching placebo 240 mg/160 mg — DRUG
    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
  • Gefitinib-matching placebo 250 mg — DRUG
    The initial dose for Gefitinib-matching placebo (250 mg once daily) cannot be reduced to a lower dose

Study Details

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

Key Dates

Start date
Feb 13, 2020
Status verified
May 2026
Primary completion
Jul 29, 2022
Completion
Apr 22, 2026

Study Design

Enrollment
393 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lazertinib + Gefitinib-matching placebo
    Lazertinib (240 mg or 160 mg orally, once daily) plus Gefitinib-matching placebo (250 mg orally, once daily) in accordance with the randomization schedule
  • Active Comparator: Gefitinib + Lazertinib-matching placebo
    Gefitinib (250 mg orally, once daily) plus Lazertinib-matching placebo (240 mg or 160 mg orally, once daily) in accordance with the randomization schedule

Primary Outcome Measure

Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment [ Time Frame: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant. ]

Related coverage on Hipa.ai

Related Studies