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Study on the Best Treatment Sequence for Advanced Non-Small Cell Lung Cancer with EGFR Mutations Using Dacomitinib and Osimertinib

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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 non-small-cell lung cancer (NSCLC) that has specific changes in the EGFR gene. These changes, called EGFR mutations, can affect how cancer grows. The study is looking at two medications, dacomitinib (also known as PF-00299804) and osimertinib (also known as AZD9291), to find out the best way to use them in treating this type of lung cancer. Both medications are taken as film-coated tablets.

The purpose of the study is to determine the most effective order of using these medications in patients with advanced or metastatic NSCLC that has EGFR mutations. The study will include patients who have not been treated with these types of medications before. It will also include patients who have brain metastases, which means the cancer has spread to the brain, as long as these are not causing symptoms or are under control. The study will last for up to 36 months, during which patients will receive either dacomitinib or osimertinib first, followed by the other medication.

Participants will be randomly assigned to start with one of the two medications. The study will monitor how well the cancer responds to the treatment and how long the treatment remains effective. The goal is to find out which sequence of medications works best for patients with this type of lung cancer. This information could help doctors make better treatment decisions for future patients with similar conditions.

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
The trial begins with the administration of the first medication. Depending on the assigned group, the patient will receive either osimertinib or dacomitinib as the initial treatment.
Osimertinib is provided in the form of 80 mg film-coated tablets, taken orally once daily.
Dacomitinib is provided in the form of 15 mg film-coated tablets, taken orally once daily.
Step 2
Monitoring and assessment
Throughout the treatment, regular monitoring is conducted to assess the patient's response to the medication. This includes imaging tests and other evaluations to measure the size and progression of the cancer.
The patient's overall health and any side effects experienced are also monitored closely.
Step 3
Second-line treatment phase
If the initial treatment is no longer effective, the patient will switch to the second medication. If osimertinib was used first, the patient will switch to dacomitinib, and vice versa.
The dosage and administration remain the same: osimertinib as 80 mg tablets and dacomitinib as 15 mg tablets, both taken orally once daily.
Step 4
Ongoing evaluation
The patient's response to the second-line treatment is evaluated similarly to the initial phase, with regular assessments and monitoring of health and side effects.
Adjustments to the treatment plan may be made based on these evaluations.
Step 5
Completion of trial
The trial is expected to conclude by July 31, 2025. At this point, a final assessment will be conducted to evaluate the overall effectiveness of the treatment sequence.
The results will contribute to understanding the best sequence of medications for treating advanced or metastatic non-small-cell lung cancer with EGFR mutations.

Who can join the trial?

16 criteria

Provide written informed consent to participate in the study.
Be a male or female patient aged 18 years or older.
Have a confirmed diagnosis of stage IIIB or IV NSCLC (a type of lung cancer) with specific changes in the EGFR gene, which can be detected through a tissue sample or blood test.
Be eligible to receive a specific treatment called osimertinib as the first or second treatment option, as decided by the doctor.
If you have brain metastases (cancer spread to the brain), they must be without symptoms and stable, meaning no worsening for at least two weeks before starting the study treatment.
Have no other genetic changes that drive cancer, such as KRAS, HER2, ALK, ROS1, MET, or BRAF mutations.
Have not received previous treatment with EGFR-TKI therapy (a type of cancer drug). Previous radiation or surgery for symptom relief is allowed, as well as certain chemotherapy if completed at least six months before the advanced cancer diagnosis.
Have at least one area of cancer that can be measured by imaging tests.
Have a performance status of 0-1, which means you are fully active or have some symptoms but can still carry out light work.
Be willing to follow the study procedures.
Have adequate bone marrow function, which means having enough blood cells to fight infection, prevent bleeding, and carry oxygen.
Have adequate liver function, meaning liver enzymes and bilirubin levels are within acceptable limits.
Have normal levels of alkaline phosphatase and creatinine, which are indicators of bone and kidney health.
Female patients must use effective birth control, not be breastfeeding, and have a negative pregnancy test before starting the study. Alternatively, they must be unable to have children due to menopause or surgery.
Male patients must agree to use condoms as a form of birth control.
Have no significant health issues that would prevent participation in the study, as determined by the doctor.

Who cannot join the trial?

3 criteria

Patients who have already received treatment for their **advanced or metastatic EGFR mutation positive NSCLC** cannot participate. This means if you have already been treated for this specific type of lung cancer, you are not eligible.
Patients with **uncontrolled brain metastases** are excluded. Brain metastases are cancer cells that have spread to the brain. If these are not under control, participation is not allowed.
Patients who are part of a **vulnerable population** are not eligible. This generally refers to groups who may need special protection or care, such as children or those unable to give consent.

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Verified sites

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

Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy
Universita' Degli Studi Di Verona
Responsive
Verona, Italy

Trial locations

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Investigated drugs

Dacomitinib
is a medication used in this study to treat patients with advanced or metastatic non-small-cell lung cancer (NSCLC) that have specific mutations in the epidermal growth factor receptor (EGFR). It works by blocking the activity of the EGFR, which can help slow down or stop the growth of cancer cells. This study aims to understand how effective dacomitinib is, especially in patients who have brain metastases that are either asymptomatic or controlled.
Osimertinib
is another medication being investigated in this study for its effectiveness in treating advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR mutations. Like dacomitinib, osimertinib targets the EGFR to inhibit cancer cell growth. The study seeks to determine the best sequence of using these medications to achieve the most effective treatment outcomes for patients with these specific types of lung cancer.

What is already known about the treatment

Dacomitinib
Dacomitinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic non-small-cell lung cancer (NSCLC) with specific EGFR mutations. The medication works by inhibiting the activity of the epidermal growth factor receptor (EGFR), which is involved in the growth and spread of cancer cells. Dacomitinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.
Osimertinib
Osimertinib is taken orally as a tablet. It is under investigation in clinical trials for its potential to treat advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR mutations. The drug functions by blocking the activity of the epidermal growth factor receptor (EGFR), which plays a role in cancer cell proliferation. Osimertinib is part of the pharmacological class known as tyrosine kinase inhibitors, which are designed to target specific pathways in cancer cells.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) with EGFR Mutation – This is a type of lung cancer characterized by the presence of mutations in the epidermal growth factor receptor (EGFR) gene. These mutations lead to uncontrolled cell growth and division, contributing to the development and progression of cancer. NSCLC with EGFR mutations often presents as advanced or metastatic disease, meaning it has spread beyond the lungs to other parts of the body. The disease can include both classical and uncommon activating mutations, which influence how the cancer behaves and responds to treatment. Patients may experience symptoms such as persistent cough, chest pain, and difficulty breathing. The presence of brain metastases is possible, which can affect neurological function.