Clinical Trial: NCT04248829
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Yuhan Corporation |
| Information Provided By: | Yuhan Corporation |
| Last Update Posted: | 2026-06-29 |
Study Overview
Brief 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
Official Title
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
Conditions
Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: Lazertinib 240 mg/160 mg
- Drug: Gefitinib 250 mg
- Drug: Lazertinib-matching placebo 240 mg/160 mg
- Drug: Gefitinib-matching placebo 250 mg
Other Study ID Numbers
- YH25448-301
Start Date (Actual)
2020-02-13
Primary Completion Date (Actual)
2022-07-29
Study Completion Date (Actual)
2026-04-22
Enrollment (Actual)
393
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Yuhan Corporation |
| Information Provided By: | Yuhan Corporation |
| Last Update Posted: | 2026-06-29 |
Study Overview
Brief 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
Official Title
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
Conditions
Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: Lazertinib 240 mg/160 mg
- Drug: Gefitinib 250 mg
- Drug: Lazertinib-matching placebo 240 mg/160 mg
- Drug: Gefitinib-matching placebo 250 mg
Other Study ID Numbers
- YH25448-301
Start Date (Actual)
2020-02-13
Primary Completion Date (Actual)
2022-07-29
Study Completion Date (Actual)
2026-04-22
Enrollment (Actual)
393
Study Type
Interventional
Phase
Phase 3