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Study on EGFR-Mutated Lung Cancer: Evaluating Dacomitinib, Afatinib, and Osimertinib for Patients Not Suitable for Curative Treatment

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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 non-small cell lung cancer (NSCLC). This form of cancer is characterized by specific changes in the EGFR gene, which can affect how cancer cells grow and respond to treatment. The study aims to explore the best sequence of treatments using medications called EGFR-inhibitors, which are designed to target and block the activity of the EGFR protein, potentially slowing down or stopping the growth of cancer cells.

The trial involves three different medications: Osimertinib (also known by its code name AZD9291), Dacomitinib (also known as PF-00299804), and Afatinib (also referred to as BIBW-2992). These medications belong to a class of drugs called Tyrosine Kinase Inhibitors, which work by interfering with specific enzymes that are involved in the growth and spread of cancer cells. Participants in the study will receive one or more of these medications, and their progress will be monitored over a period of time to determine the most effective treatment sequence.

The purpose of the study is to evaluate how well these medications work in treating EGFR-mutated NSCLC and to understand the sequence in which they should be administered for the best outcomes. Participants will take the medications orally, and the study will track various aspects of their health, including how long they live without the cancer getting worse, their overall survival, and any side effects they experience. The study will also look at how the cancer responds to treatment and any changes in the cancer's genetic makeup that might affect treatment. This information will help researchers learn more about the disease and improve treatment strategies for future patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study's purpose and procedures.
A negative pregnancy test is necessary if applicable. This can be done through a blood or urine test.
Step 2
Initial assessments
You will undergo assessments to confirm a diagnosis of EGFR-mutated non-small cell lung cancer (NSCLC). This involves checking your medical history and possibly conducting tests to confirm the presence of specific mutations.
Your disease stage will be evaluated to ensure it is not suitable for curative treatment.
Step 3
Treatment plan
You will be assigned a treatment plan involving one of the following medications: dacomitinib, afatinib, or osimertinib. These are taken orally.
The dosage and frequency will be determined by the study team based on your specific condition and response to treatment.
Step 4
Ongoing monitoring
Throughout the study, your health and response to the medication will be closely monitored. This includes regular check-ups and tests to assess progression-free survival (PFS) and other health indicators.
Blood samples may be taken to analyze tumor-derived cell-free DNA and other markers to monitor treatment response and detect any resistance to the medication.
Step 5
Evaluation of treatment response
Your response to the treatment will be evaluated using various criteria, such as objective response rate (ORR) and disease control rate (DCR).
Quality of life assessments will be conducted using the Lung Cancer Symptom Scale (LCSS) to ensure your well-being during the trial.
Step 6
Completion of the study
The study is expected to continue until December 31, 2028. Your participation may end earlier if the treatment is no longer effective or if you choose to withdraw.
Upon completion, final assessments will be conducted to evaluate the overall impact of the treatment on your health.

Who can join the trial?

10 criteria

Provide written informed consent, which means you agree to participate after being informed about the study.
Have a negative pregnancy test (either a blood or urine test) to confirm you are not pregnant.
Have a diagnosis of non-small cell lung cancer (NSCLC) confirmed by a tissue sample.
Have cancer that is at stage III or IV, or has come back and cannot be treated with the aim of curing it.
Have a measurable disease according to specific medical criteria, which means the cancer can be measured in size.
Any WHO Performance Status (PS), which refers to your general well-being and ability to carry out daily activities.
Be 18 years or older.
Have an EGFR mutation in your tumor. If tumor tissue is not available, a blood test for circulating tumor DNA can be used.
Have not received treatment with TKIs (a type of cancer drug) before.
If you are able to have children, use adequate contraception such as an intrauterine device, surgical sterilization, or abstinence. Avoid pregnancy during treatment and for the first 4 months after stopping treatment.

Who cannot join the trial?

3 criteria

Patients who have a different type of cancer than EGFR-mutated non-small cell lung cancer (NSCLC).
Patients who are able to receive treatment that aims to cure their cancer.
Patients who are not candidates for EGFR-inhibitor treatment as their first treatment option. An EGFR-inhibitor is a type of medication that blocks a protein called EGFR, which can help stop cancer cells from growing.

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Verified sites

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Karolinska University Hospital
Verified
Solna, Sweden
Region Oestergoetland
Responsive
Linkoping, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden

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Investigated drugs

EGFR-inhibitors are a type of medication used in this clinical trial. They work by blocking a specific protein called the epidermal growth factor receptor (EGFR), which is often involved in the growth and spread of cancer cells. By inhibiting this protein, these medications aim to slow down or stop the progression of cancer, particularly in patients with certain types of lung cancer that have mutations in the EGFR gene. The trial is focused on finding the best way to use these inhibitors to treat patients effectively.

What is already known about the treatment

EGFR-inhibitor – This medication is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating a specific type of lung cancer known as EGFR-mutated non-small cell lung cancer (NSCLC). It is particularly used for patients who cannot undergo curative treatment and are candidates for first-line therapy with EGFR inhibitors. The medication works by blocking the activity of a protein called EGFR, which is involved in the growth and spread of cancer cells. It belongs to a class of drugs known as tyrosine kinase inhibitors, which help slow down or stop the growth of cancer.

Investigated diseases

EGFR-mutated non-small cell lung cancer (NSCLC) – This type of lung cancer is characterized by mutations in the epidermal growth factor receptor (EGFR) gene, which leads to uncontrolled cell growth. It primarily affects the epithelial cells lining the lungs. The disease progresses as cancer cells multiply and form tumors, which can invade nearby tissues and spread to other parts of the body. Over time, the cancer may become resistant to certain treatments, particularly those targeting the EGFR pathway. This resistance can lead to further tumor growth and spread. The progression of the disease is often monitored through various biomarkers and genetic alterations.