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

Launched by YUHAN CORPORATION · Jan 28, 2020

Keywords

ClinConnect Summary

The LASER301 clinical trial is studying a new treatment called YH25448 (also known as Lazertinib) for patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC). This trial focuses on individuals who have advanced or spreading NSCLC and carry certain mutations in a gene called EGFR, which makes them more likely to benefit from this treatment. To be eligible for this trial, participants must have a confirmed diagnosis of adenocarcinoma (a type of lung cancer) that cannot be treated with surgery or radiation, and they must be newly diagnosed with advanced disease. Additionally, they should have at least one measurable tumor and a good performance status, meaning they are relatively healthy and can carry out daily activities.

During the trial, participants will receive the study treatment and will be monitored for any side effects and how well the treatment works. It's important to note that individuals with certain medical conditions, such as unstable brain metastases or significant heart disease, cannot participate in the study. This trial is currently active but not recruiting new participants, which means they are not looking for more people to join at this time. If you or a loved one is considering participation, it's always a good idea to discuss it with a healthcare provider to understand the potential benefits and risks.

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ALL

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