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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514771-18-00

Acronym

YH25448-301

Enrollment

Registered

2024-08-21

Start date

2020-12-15

Completion date

Unknown

Last updated

2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of the lung (non-small cell lung cancer); locally advanced or metastatic, not amenable to curative surgery or radiotherapy

Brief summary

Progression-free survival according to RECIST v1.1 by Investigator assessment

Detailed description

• Objective Response Rate (ORR) • Duration of Response (DoR) • Disease Control Rate (DCR) • Depth of Response • Time to Response All according to RECIST v1.1 by Investigator assessments, Overall survival (OS), • Plasma concentrations of lazertinib • Cerebrospinal fluid (CSF) concentrations of lazertinib, Change from baseline in : • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items (EORTC QLQ-C30) • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Lung Cancer 13 items (EORTC QLQ-LC13) • Euro-Quality of Life-5 Dimension-5 level (EQ-5D-5L)

Interventions

DRUGGefitinib-ratiopharm 250 mg Filmtabletten

DRUGLazertinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival according to RECIST v1.1 by Investigator assessment	—

Secondary

Measure	Time frame
• Objective Response Rate (ORR) • Duration of Response (DoR) • Disease Control Rate (DCR) • Depth of Response • Time to Response All according to RECIST v1.1 by Investigator assessments, Overall survival (OS), • Plasma concentrations of lazertinib • Cerebrospinal fluid (CSF) concentrations of lazertinib, Change from baseline in : • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items (EORTC QLQ-C30) • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Lung Cancer 13 items (EORTC QLQ-LC13) • Euro-Quality of Life-5 Dimension-5 level (EQ-5D-5L)	—

Measure

Time frame

—

Countries

Greece, Hungary

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026