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

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC), specifically in cases where the cancer is locally advanced or has spread to other parts of the body (metastatic). The study is investigating two treatments: Lazertinib and Gefitinib. Both medications are taken orally in tablet form. Lazertinib is being tested under the code name YH25448A. The purpose of the study is to compare the effectiveness and safety of Lazertinib against Gefitinib as the first treatment option for patients with this type of lung cancer.

Participants in the study will receive either Lazertinib or Gefitinib. The study will monitor how long the cancer does not worsen, which is known as progression-free survival. The trial will also look at other factors such as the overall response to the treatment, how long any response lasts, and the overall survival of the participants. Additionally, the study will measure the levels of Lazertinib in the blood and cerebrospinal fluid, which is the fluid surrounding the brain and spinal cord. Participants’ quality of life will also be assessed using questionnaires designed to evaluate the impact of the treatment on their daily lives.

This study is important for understanding which treatment might be more effective for patients with NSCLC that have specific mutations in the epidermal growth factor receptor (EGFR), which is a protein that can affect the growth of cancer cells. The trial aims to provide valuable information that could help improve treatment options for patients with this type of lung cancer.

1 randomization

Upon joining the study, you will be randomly assigned to receive either lazertinib or gefitinib. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment.

2 treatment administration

If assigned to the lazertinib group, you will take a tablet orally once a day. The dosage and specific instructions will be provided by the study team.

If assigned to the gefitinib group, you will take a 250 mg film-coated tablet orally once a day. Detailed instructions will be given by the study team.

3 regular assessments

Throughout the study, regular assessments will be conducted to monitor your health and the effectiveness of the treatment. These assessments may include physical exams, imaging tests, and laboratory tests.

4 progression-free survival evaluation

The main objective of the study is to evaluate progression-free survival, which means the length of time during and after treatment that the cancer does not worsen. This will be assessed by the study investigators using specific criteria.

5 secondary outcomes evaluation

Secondary outcomes such as objective response rate, duration of response, and overall survival will also be evaluated. These outcomes help to understand the broader effects of the treatment.

6 quality of life assessments

Your quality of life will be assessed using questionnaires designed to evaluate your overall well-being and any changes in your condition during the study.

7 study completion

The study is expected to conclude by June 30, 2026. At the end of the study, final assessments will be conducted to gather comprehensive data on the treatment’s efficacy and safety.

Who Can Join the Study?

The patient must have a confirmed diagnosis of adenocarcinoma of the lung, which is a type of lung cancer.
The cancer must be locally advanced (spread to nearby areas) or metastatic (spread to other parts of the body) and cannot be treated with surgery or radiation to cure it.
The patient must have at least one of the two common EGFR mutations (changes in a specific gene) that are known to respond to certain treatments. These mutations are called Ex19del or L858R.
The patient should not have received any treatment for their locally advanced or metastatic lung cancer before.
The patient must have a WHO performance status score of 0 to 1, which means they are fully active or have some symptoms but do not need to stay in bed.
The patient must have at least one measurable lesion (an area of cancer that can be measured) that has not been treated with radiation and will not be used for a biopsy during the study’s screening period.
Both male and female patients are eligible to participate.
The study includes patients from vulnerable populations, which means it considers those who might need special attention or care.

Who Cannot Join the Study?

Patients who have had previous treatment with certain medications that target the same cancer pathway.
Patients with other active cancers that require treatment.
Patients with serious heart conditions that are not well controlled.
Patients with severe liver or kidney problems.
Patients who are pregnant or breastfeeding.
Patients who have had a major surgery within the last 4 weeks.
Patients with a history of certain lung diseases that are not related to cancer.
Patients who are unable to swallow pills.
Patients with known allergies to the study medications.
Patients who are participating in another clinical trial.

Where you can join this trial?

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Other Sites

Site Name	City	Country
University Of Debrecen	Debrecen	Hungary
Tuedogyogyintezet Toeroekbalint	Torokbalint	Hungary
Tmuzaunvic Cecpzx Hzxorpym	Thessaloniki	Greece
Ukcenisuza Ghjeksj Hblqvize Ashnbeu	Athens	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	25.08.2020
Hungary	Not recruiting	25.08.2020

Trial locations

Investigated drugs:

Lazertinib is a medication being studied for its effectiveness in treating patients with a specific type of lung cancer known as non-small cell lung cancer. This medication targets cancer cells that have certain mutations in the epidermal growth factor receptor (EGFR), which can help slow down or stop the growth of the cancer.

Gefitinib is another medication used in the treatment of non-small cell lung cancer. It works by blocking the activity of the EGFR, which is often involved in the growth and spread of cancer cells. This medication is being compared to lazertinib to determine which is more effective as a first-line treatment for patients with EGFR mutations.

Investigated diseases:

Non-small cell lung cancer metastatic

Adenocarcinoma of the lung (non-small cell lung cancer) – This is a type of cancer that begins in the glandular cells of the lung, which are responsible for producing mucus and other substances. It is classified as non-small cell lung cancer, which is the most common type of lung cancer. The disease can be locally advanced, meaning it has spread to nearby tissues or lymph nodes, or metastatic, indicating it has spread to other parts of the body. It is not suitable for curative surgery or radiotherapy, which means these treatments cannot completely remove or destroy the cancer. The progression of the disease involves the growth and spread of cancer cells, which can lead to symptoms such as coughing, chest pain, and difficulty breathing. As the disease advances, it may affect the function of the lungs and other organs.

Trial ID:

2024-514771-18-00

Protocol code:

YH25448-301

NCT ID:

NCT04248829

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?