Lung adenocarcinoma stage IV 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 trial is investigating treatment options for patients with lung adenocarcinoma that has either spread locally or to other parts of the body. The study compares two oral medications: Lazertinib and Gefitinib, both of which target specific mutations in cancer cells.

Who can participate:

• Patients with confirmed adenocarcinoma of the lung that is locally advanced or has spread to other parts of the body and cannot be cured with surgery or radiation
• Patients whose cancer cells have specific EGFR mutations (either Ex19del or L858R), which are genetic changes that make the cancer respond to certain treatments
• Patients who have not received any previous treatment for their advanced cancer
• Patients who are mostly active or have some symptoms but do not need to stay in bed (WHO performance status 0-1)
• Patients who have 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 previously been treated with medications that target the same cancer pathway
• Patients with other active cancers requiring treatment
• Patients with serious, uncontrolled heart conditions
• Patients with severe liver or kidney problems
• Pregnant or breastfeeding women
• Patients who have had major surgery within the last 4 weeks
• Patients with certain lung diseases unrelated to cancer
• Patients who cannot swallow pills
• Patients with known allergies to the study medications
• Patients already participating in another clinical trial

What the trial involves:

The main goal of this study is to determine which medication is more effective as a first-line treatment. Participants will be randomly assigned to receive either Lazertinib or Gefitinib, both taken as tablets once daily. Lazertinib is an investigational drug being tested under the code name YH25448A, while Gefitinib is an established treatment for this type of cancer.

Both medications work by blocking a protein called the epidermal growth factor receptor (EGFR), which is often involved in the growth and spread of cancer cells. They belong to a class of drugs called tyrosine kinase inhibitors, which are designed to target specific pathways that cancer cells use to grow and multiply.

During the study, researchers will monitor how long the cancer remains stable without getting worse, known as progression-free survival. They will also track other important factors such as how well the treatment works overall, how long any positive response lasts, and the overall survival of participants. Additionally, the study will measure drug levels in the blood and cerebrospinal fluid, and assess participants' quality of life using specialized questionnaires.

Regular assessments throughout the trial will include physical examinations, imaging tests, and laboratory tests to monitor your health and the treatment's effectiveness. The study is expected to conclude by June 30, 2026.

Investigational drugs:

Lazertinib is administered orally and specifically targets cancer cells with EGFR mutations. It works by inhibiting the activity of the EGFR protein, helping to slow down or stop cancer cell growth and division.

Gefitinib is taken as a 250 mg film-coated tablet once daily. It also blocks EGFR activity and is already used in clinical practice for patients with EGFR mutations, making it the comparison treatment in this study.

Summary

Currently, there is one clinical trial available for patients with stage IV lung adenocarcinoma, specifically for those whose cancer has spread and cannot be treated with surgery or radiation. This trial is particularly important for patients whose tumors have specific EGFR mutations, as it compares a new investigational drug (Lazertinib) with an established treatment (Gefitinib).

The trial is being conducted in two European countries: Hungary and Greece. This study represents an opportunity for treatment-naïve patients to access targeted therapy that specifically addresses the genetic characteristics of their cancer. Both medications in the trial are oral therapies, which may offer convenience compared to intravenous treatments.

Patients interested in this trial should discuss with their healthcare provider whether they meet the eligibility criteria, particularly regarding EGFR mutation status, which must be confirmed through genetic testing of the tumor.