RecruitingRare disease

Study comparing firmonertinib with osimertinib or afatinib for patients with advanced lung cancer with uncommon EGFR mutations

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What is this trial about?

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

This study involves people with a type of lung cancer called Non-Small-Cell Lung Cancer that has spread to other parts of the body or has grown in a way that cannot be removed by surgery or treated with radiation therapy alone. The cancer has specific uncommon changes in a protein called Epidermal Growth Factor Receptor, known as PACC mutations, which affect how cancer cells grow. The study will test a medicine called firmonertinib, which is also known by other names including alflutinib, and compare it with one of two other medicines that doctors already use to treat this type of lung cancer. These comparison medicines are osimertinib and afatinib, and the doctor treating each person will choose which one to use. All of these medicines are taken by mouth as tablets.

The purpose of the study is to find out if firmonertinib works better than the doctor's choice of osimertinib or afatinib in stopping the cancer from getting worse, and to see how many people respond to the treatment. The study will also look at how safe these medicines are and what side effects they may cause. People taking part will receive one of these medicines as their first treatment for cancer that has spread or grown too much to be cured by surgery or radiation.

During the study, people will be divided into groups by chance, similar to flipping a coin, and will receive either firmonertinib or the doctor's choice of osimertinib or afatinib. Treatment can continue for up to 18 months or longer if the medicine is helping to control the cancer. Throughout the study, doctors will monitor how well the treatment is working and check for any side effects. Both the people in the study and their doctors will know which medicine is being given, as this is not a blinded study.

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
Treatment assignment
Upon joining the study, your doctor will determine which treatment you will receive. The study compares firmonertinib with either osimertinib or afatinib.
All medications in this study are taken by mouth in tablet form.
The choice between osimertinib or afatinib as a comparison treatment will be made by your doctor based on medical judgment.
Step 2
Treatment period
You will receive one of the assigned medications as your first treatment for locally advanced or spread lung cancer with specific genetic changes in the epidermal growth factor receptor, a protein that affects how cancer cells grow.
The treatment will continue according to the study protocol. Your doctor will monitor how the treatment is working and how you are tolerating it.
The medications target the specific genetic changes in your cancer cells to help slow or stop their growth.
Step 3
Regular monitoring and assessments
Throughout the study, your disease progression will be monitored through regular assessments.
Independent medical experts who do not know which treatment you are receiving will review your scans and test results to determine if the cancer is responding to treatment.
These assessments will measure how long the cancer remains stable or shrinks, and whether the cancer responds to the treatment.
Step 4
Safety monitoring
Your health and any side effects from the medication will be monitored regularly throughout your participation in the study.
Your doctor will assess how safe the treatment is for you and whether any adjustments are needed.
Step 5
Study participation duration
The study is expected to continue until December 2030.
Your individual participation length will depend on how you respond to treatment and how well you tolerate the medication.
The study will track your progress over time to evaluate the effectiveness of the treatment.

Who can join the trial?

7 criteria

You must have non-small cell lung cancer (a type of lung cancer) that has spread to other parts of the body or is advanced, and cannot be treated with surgery or radiation therapy to cure the disease
Your cancer must have a specific genetic change called an EGFR PACC mutation (a change in a gene that affects how cancer cells grow), confirmed by testing your tumor tissue or blood sample
You must not have received any previous treatment with medications for your advanced or metastatic (cancer that has spread) lung cancer, including any drugs that target EGFR (a protein on cancer cells)
If you received treatment before or after surgery, or treatment with chemotherapy, immunotherapy, or combined chemotherapy and radiation for cancer that had not spread, at least 12 months must have passed since that treatment ended
If you have cancer that has spread to your brain or spinal cord (CNS metastases), you can participate only if you have no symptoms from it
Adults of all ages can participate in this study
Both men and women can participate in this study

Who cannot join the trial?

12 criteria

You cannot participate if you have brain metastases (cancer that has spread to the brain) that are causing symptoms or require treatment with steroids (anti-inflammatory medications)
You cannot participate if you have spinal cord compression (pressure on the spinal cord from cancer) that has not been treated or is not stable
You cannot participate if you have certain heart problems, including abnormal heart rhythm that cannot be controlled with medication, heart failure (when the heart cannot pump blood properly), or a recent heart attack within the past 6 months
You cannot participate if you have severe liver disease or your liver is not working properly based on blood test results
You cannot participate if you have severe kidney disease or your kidneys are not working properly
You cannot participate if you have any other active cancer that requires treatment
You cannot participate if you have an active infection that requires treatment with antibiotics given through a vein
You cannot participate if you are pregnant or breastfeeding
You cannot participate if you have received certain types of cancer treatment within a specific time before joining the study
You cannot participate if you have had major surgery within 4 weeks before starting the study treatment
You cannot participate if you have a known allergy or severe reaction to the study medications or similar drugs
You cannot participate if you are unable to swallow pills or have stomach or intestinal problems that would prevent you from absorbing the medication properly

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Athens Medical Center S.A.
Verified
Thessaloniki, Greece
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

Trial locations

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Investigated drugs

Firmonertinib
is a targeted cancer medication that works by blocking certain proteins in cancer cells that help them grow and spread. It is specifically designed to treat lung cancer that has changes in a protein called EGFR.
Osimertinib
is a targeted cancer medication that blocks specific proteins in cancer cells to stop them from growing. It is used to treat a type of lung cancer that has specific changes in the EGFR protein.
Afatinib
is a targeted cancer medication that blocks signals that tell cancer cells to grow and multiply. It is used to treat lung cancer that has specific changes in the EGFR protein.

What is already known about the treatment

Firmonertinib
Firmonertinib is an oral medication currently being studied in clinical trials for the treatment of advanced or metastatic non-small-cell lung cancer that has specific uncommon mutations in the epidermal growth factor receptor gene. This drug works by blocking the activity of the abnormal epidermal growth factor receptor protein, which helps cancer cells grow and divide uncontrollably. It belongs to a class of medications called targeted cancer therapies, specifically designed to attack cancer cells with particular genetic changes while causing less harm to normal cells. The medication is being compared with other similar treatments to determine if it can effectively stop or slow down cancer growth in patients with these rare genetic mutations.
Osimertinib
Osimertinib is an oral tablet that is already approved and widely used in medical practice for treating certain types of lung cancer with specific genetic mutations. This medication works by blocking the epidermal growth factor receptor, a protein that sends signals telling cancer cells to grow and multiply, thereby helping to slow or stop the spread of cancer. It is classified as a targeted therapy, which means it specifically attacks cancer cells with certain genetic characteristics rather than affecting all rapidly dividing cells like traditional chemotherapy. In this clinical trial, it serves as one of the comparison treatments to evaluate the effectiveness of a newer experimental medication.
Afatinib
Afatinib is an oral medication taken as a tablet that is currently approved for treating non-small-cell lung cancer with certain genetic mutations affecting the epidermal growth factor receptor. This drug works by permanently blocking multiple proteins in the epidermal growth factor receptor family that send signals for cancer cells to grow and spread throughout the body. It belongs to a group of cancer treatments called tyrosine kinase inhibitors, which are targeted therapies that focus on specific molecules involved in cancer growth rather than attacking all fast-growing cells. In this study, it is being used as one of the standard treatment options to compare against an investigational new drug.

Investigated diseases

Non-Small-Cell Lung Cancer – Non-small-cell lung cancer is a type of cancer that begins in the lungs and is the most common form of lung cancer. The disease occurs when cells in the lung tissue grow abnormally and uncontrollably, forming tumors. As the cancer progresses, it can spread from the original location in the lung to nearby tissues and lymph nodes. In advanced stages, the cancer may spread to distant parts of the body through the bloodstream or lymphatic system, which is called metastasis. Some cases of this cancer involve specific changes in genes, such as mutations in the epidermal growth factor receptor, which affect how the cancer cells grow and respond to signals. The disease can progress at different rates depending on the specific genetic changes present in the cancer cells.