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Study on Skin Care for Patients with Advanced EGFR-Mutated Lung Cancer Treated with Amivantamab and Lazertinib

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC). The study is investigating the effects of two medications, amivantamab and lazertinib, which are used together as a first-line treatment for this condition. The purpose of the study is to see if a special approach to managing skin-related side effects can reduce their occurrence compared to the usual care.

Participants in the study will receive either the enhanced skin care management or the standard skin care management while being treated with amivantamab and lazertinib. The study will monitor the participants over a period to observe any skin-related side effects that may occur during the first 12 weeks of treatment. The medications are administered in different forms: amivantamab is given as a solution for injection or infusion, while lazertinib is taken orally as a tablet.

The trial aims to provide insights into whether the enhanced skin care approach can better manage the skin side effects that some patients experience when treated with these medications. This study is important for improving the quality of life for patients undergoing treatment for EGFR-mutated NSCLC by potentially reducing uncomfortable skin reactions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Begin treatment with amivantamab and lazertinib. Amivantamab is administered as a solution for injection under the skin (subcutaneous use) and as a solution for infusion into a vein (intravenous use). Lazertinib is taken orally in tablet form.
The primary goal during this phase is to evaluate the impact of enhanced versus standard skin care on skin-related side effects. This phase lasts for the first 12 weeks of treatment.
Step 2
Dermatologic management
Receive either enhanced or standard skin care management to address any skin-related side effects that may occur during treatment. This management is part of the study's evaluation process.
Step 3
Medication for skin care
Use medications such as minocycline hydrochloride and doxycycline monohydrate, which are taken orally in capsule or tablet form, to help manage skin-related side effects.
Apply chlorhexidine solution and clindamycin emulsion to the skin as needed to further manage skin conditions.
Step 4
Ongoing treatment and monitoring
Continue treatment with amivantamab and lazertinib while being monitored for any changes in health status or side effects. Regular assessments will be conducted to ensure the effectiveness and safety of the treatment.
Step 5
Completion of trial
The trial is expected to conclude by March 31, 2026. Upon completion, a final assessment will be conducted to evaluate the overall impact of the treatment and skin care management on the patient's condition.

Who can join the trial?

6 criteria

Must be at least 18 years old or older, depending on the legal age of adulthood in the area where the study is conducted.
Must have a confirmed diagnosis of locally advanced or metastatic **non-small cell lung cancer (NSCLC)** that has not been treated before and cannot be cured with surgery or radiation. Previous treatments for earlier stages of the disease are allowed if they were given more than 12 months before the cancer became advanced or metastatic.
Must have a tumor with a specific change in the **EGFR gene** (either exon 19 deletion or exon 21 L858R substitution), confirmed by a test approved by the FDA or another validated test in a certified laboratory.
If there is a history of cancer spread to the brain (**brain metastases**), all brain lesions must have been treated as needed, with no further treatment required. Any treatment for brain metastases must have been completed at least 14 days before joining the study, and the participant should not be taking more than 10 mg of prednisone or an equivalent medication daily for brain-related issues.
Must have an **ECOG performance status** of 0 to 1, which is a scale used to assess how well a person can perform daily activities.
Must agree not to be pregnant, breastfeeding, or planning to become pregnant while participating in the study and for 6 months after the last dose of the study medications, amivantamab or lazertinib.

Who cannot join the trial?

5 criteria

Patients who do not have **EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer** cannot participate. This means the cancer must have a specific change in the **EGFR** gene and be in an advanced stage or have spread to other parts of the body.
Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups, so if you are outside this range, you would not be eligible.
Both **male** and **female** patients are eligible, so gender is not a reason for exclusion.
Patients who are part of a **vulnerable population** may not be eligible. This could include groups like children, pregnant women, or others who might need special protection.
Patients who do not meet other specific health criteria set by the study may be excluded. These criteria are designed to ensure the safety and effectiveness of the treatment being tested.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Responsive
Hospital Universitario De Jaen
Jaen, Spain
Responsive
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany

Trial locations

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Investigated drugs

Amivantamab
is a medication used in this trial to treat patients with a specific type of lung cancer known as EGFR-mutated non-small cell lung cancer (NSCLC). It works by targeting and blocking certain proteins that help cancer cells grow and spread.
Lazertinib
is another medication used alongside amivantamab in this trial. It is designed to specifically target and inhibit the activity of the EGFR protein, which is often mutated in certain types of lung cancer, helping to slow down or stop the growth of cancer cells.

What is already known about the treatment

Amivantamab
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic non-small cell lung cancer with EGFR mutations. It is a monoclonal antibody that targets specific proteins on cancer cells, helping the immune system to recognize and destroy them. Amivantamab is classified as an antineoplastic agent and is being evaluated for its potential to improve patient outcomes in combination with other treatments.
Lazertinib
This medication is taken orally and is also under investigation in clinical trials for its use in treating advanced or metastatic non-small cell lung cancer with EGFR mutations. Lazertinib works by inhibiting the activity of the epidermal growth factor receptor, which is involved in the growth and spread of cancer cells. It is classified as a tyrosine kinase inhibitor and is being studied for its ability to enhance the effectiveness of other cancer therapies.

Investigated diseases

EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer – This is a type of lung cancer characterized by mutations in the epidermal growth factor receptor (EGFR) gene. It primarily affects the cells lining the lungs and is known for its aggressive nature. The disease can progress from a localized state to an advanced or metastatic stage, where cancer cells spread to other parts of the body. Symptoms may include persistent cough, shortness of breath, and chest pain. As the disease advances, it can lead to more severe respiratory issues and general health decline. The progression is often monitored through imaging and clinical assessments to understand the extent of the spread.