CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 393 enrolled / 393 target
Drug / intervention
Lazertinib 240 mg/160 mg +3 moredrug
Likely dose
Lazertinib 240 mg/160 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04248829
NCT04248829Phase 3CompletedMonitor (5.1/mo)Completion was 47mo ago
CompareCT.gov

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

Yuhan Corporation·interventional·Posted Jan 30, 2020·Updated Jun 29, 2026

In Brief

A Phase 3 clinical trial evaluating Lazertinib 240 mg/160 mg, Gefitinib 250 mg, and 2 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 393 participants across 80 sites in 13 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesAustralia, Greece, Hungary, Malaysia, Philippines, Russia, Serbia, Singapore, South Korea, Taiwan, Thailand, Turkey (Türkiye), Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJan 30, 2020
Enrollment StartFeb 13, 2020
Primary CompletionJul 29, 2022
Study CompletionApr 22, 2026
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.4 years ago

Arms & Interventions

Lazertinib + Gefitinib-matching placeboexperimental

Lazertinib (240 mg or 160 mg orally, once daily) plus Gefitinib-matching placebo (250 mg orally, once daily) in accordance with the randomization schedule

Drug: Lazertinib 240 mg/160 mgDrug: Gefitinib-matching placebo 250 mg
Gefitinib + Lazertinib-matching placeboactive_comparator

Gefitinib (250 mg orally, once daily) plus Lazertinib-matching placebo (240 mg or 160 mg orally, once daily) in accordance with the randomization schedule

Drug: Gefitinib 250 mgDrug: Lazertinib-matching placebo 240 mg/160 mg

Interventions

Lazertinib 240 mg/160 mgdrug

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 mgdrug

The initial dose for Gefitinib (250 mg once daily) cannot be reduced to a lower dose

Lazertinib-matching placebo 240 mg/160 mgdrug

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 mgdrug

The initial dose for Gefitinib-matching placebo (250 mg once daily) cannot be reduced to a lower dose