Phase 3
Completed N=393
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
Source: ClinicalTrials.gov NCT04248829 ↗Enrolled (actual)
393
Serious AEs
26.0%
Results posted
Mar 2024
Primary outcomePrimary: Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment — 20.6; 9.7 Months
◆ Published Evidence
Highly cited
153citations · ~51 / year
Lazertinib Versus Gefitinib as First-Line Treatment in Patients With <i>EGFR</i>-Mutated Advanced Non-Small-Cell Lung Cancer: Results From LASER301.
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
Linked Publications (2)
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Lazertinib Versus Gefitinib as First-Line Treatment in Patients With <i>EGFR</i>-Mutated Advanced Non-Small-Cell Lung Cancer: Results From LASER301.
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Central Nervous System Outcomes of Lazertinib Versus Gefitinib in EGFR-Mutated Advanced NSCLC: A LASER301 Subset Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment |
20.6; 9.7 | — |
| SECONDARY Objective Response Rate (ORR) According to RECIST v1.1 by Investigator Assessments |
76.0; 76.1 | — |
| SECONDARY Duration of Response (DoR) According to RECIST v1.1 by Investigator Assessments |
19.4; 8.3 | — |
| SECONDARY Disease Control Rate (DCR) According to RECIST v1.1 by Investigator Assessments |
93.9; 93.9 | — |
| SECONDARY Depth of Response According to RECIST v1.1 by Investigator Assessments |
— | — |
| SECONDARY Time to Response According to RECIST v1.1 by Investigator Assessments |
— | — |
| SECONDARY Overall Survival (OS) |
49; 64; 147; 133 | — |
| SECONDARY Plasma Concentrations of Lazertinib |
— | — |
| SECONDARY Cerebrospinal Fluid (CSF) Concentrations of Lazertinib |
— | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 Items (QLQ-C30) |
— | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Lung Cancer 13 Items (EORTC QLQ-LC13) |
— | — |
| SECONDARY Change From Baseline in Euro-Quality of Life-5 Dimension-5 Level (EQ-5D-5L) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Pathologically confirmed adenocarcinoma of the lung
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
- At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations
- Treatment-naïve for locally advanced or metastatic NSCLC
- WHO performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization
- At least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study Screening period
Exclusion Criteria
- Symptomatic and unstable brain metastases
- Leptomeningeal metastases
- Symptomatic spinal cord compression
- History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- Any medical conditions requiring chronic continuous oxygen therapy
- History of any malignancy other than the disease under study within 3 years before randomization
- Any cardiovascular disease as follows:
- History of symptomatic chronic heart failure or serious cardiac arrhythmia requiring active treatment
- History of myocardial infarction or unstable angina within 24 weeks of randomization
Data sourced from ClinicalTrials.gov (NCT04248829) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.