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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Gefitinib; Lazertinib

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