Lung adenocarcinoma stage III Trials in Disease

Study on the Effectiveness and Safety of Lazertinib and Gefitinib for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

This clinical trial is comparing two oral medications, Lazertinib and Gefitinib, as first-line treatments for patients with locally advanced or metastatic non-small cell lung cancer. The study specifically focuses on patients whose cancer has particular changes in the epidermal growth factor receptor gene, known as EGFR mutations.

Who can participate:

• Patients with confirmed adenocarcinoma of the lung that is locally advanced or has spread to other parts of the body
• The cancer cannot be treated with surgery or radiation to cure it
• Patients must have specific EGFR mutations (Ex19del or L858R)
• No previous treatment for locally advanced or metastatic disease
• WHO performance status of 0 to 1, meaning patients are fully active or have some symptoms but remain out of bed
• At least one measurable area of cancer that can be tracked during the study
• Both male and female patients are eligible

Who cannot participate:

• Patients who have received previous treatment with medications targeting the same cancer pathway
• Those with other active cancers requiring treatment
• Patients with serious, uncontrolled heart conditions
• Those with severe liver or kidney problems
• Pregnant or breastfeeding women
• Patients who had major surgery within the last 4 weeks
• Those with certain lung diseases unrelated to cancer
• Patients unable to swallow pills
• Those with known allergies to the study medications
• Patients currently participating in another clinical trial

What the trial involves:

The study aims to determine which medication is more effective at keeping the cancer from getting worse. Participants are randomly assigned to receive either Lazertinib or Gefitinib, both taken as tablets once daily. Throughout the study, patients undergo regular health assessments including physical exams, imaging tests, and laboratory tests to monitor the effectiveness of the treatment and any side effects.

The main goal is to evaluate progression-free survival, which measures how long the cancer remains stable without worsening. The study also looks at other important factors such as how well the cancer responds to treatment, how long any improvement lasts, and overall survival. Additionally, researchers measure drug levels in the blood and cerebrospinal fluid, and assess patients' quality of life through questionnaires.

Investigational drugs:

Lazertinib is a medication being studied for treating non-small cell lung cancer with EGFR mutations. It works by blocking the activity of the EGFR protein, which can help slow down or stop cancer cell growth. It belongs to a class of drugs called tyrosine kinase inhibitors.

Gefitinib is an established treatment for non-small cell lung cancer with EGFR mutations. Like Lazertinib, it blocks EGFR activity to help control cancer growth. This medication is given as a 250 mg tablet taken once daily and serves as the comparison treatment in this study.

The trial is being conducted in Greece and Hungary and is expected to conclude by June 30, 2026.