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Study on Extending Osimertinib Dosing for Patients with EGFR Mutated Advanced Non-Small Cell Lung Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study looks at people with EGFR mutated locally advanced or metastatic non‑small cell lung cancer, a type of lung cancer that has spread beyond the lungs and carries a specific genetic change that helps the tumor grow. The treatment being tested is a pill called TAGRISSO, whose active ingredient is osimertinib, taken by mouth.

The purpose of the study is to find out whether giving the medication less often (an extended dosing interval) works at least as well as the usual daily schedule. Participants will receive the drug on the new schedule and will have regular visits for safety checks and simple tests over a period of several months, without any additional procedures.

The main result the researchers will look at is progression‑free survival, which means the length of time the cancer does not get worse. They will also collect information on overall survival (how long participants live), side effects that patients notice themselves, the cost of treatment, quality of life (how well people feel day to day), the chance of cancer spreading to the brain (central nervous system metastases), and how easy it is for patients to follow the medication schedule.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of the trial

    Upon joining the clinical trial, you will start by taking the medication osimertinib. This medication is provided in the form of TAGRISSO 80 mg film-coated tablets.

    You will take one tablet orally every day. This is referred to as taking the medication once daily.

  2. Step 2

    Treatment phase

    During the treatment phase, you will continue taking the osimertinib tablet daily. The trial aims to assess if extending the time between doses is as effective as the standard daily dosage.

    Regular check-ups will be scheduled to monitor your health and the effectiveness of the treatment. These check-ups will include assessments of your response to the medication.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, your health will be closely monitored. This includes evaluating your progression-free survival, which means the length of time during and after the treatment that you live with the disease without it getting worse.

    Additional assessments will focus on your overall survival, any side effects you experience, and your quality of life. These assessments help determine the impact of the treatment on your daily life.

  4. Step 4

    End of trial participation

    Your participation in the trial will continue until the trial's estimated end date or until your doctor advises otherwise based on your health and response to the treatment.

    At the end of your participation, a final assessment will be conducted to evaluate the overall outcomes of the treatment and its effects on your health.

Who can join the trial?

7 criteria

  • Age must be 18 years or older.
  • Must be able to understand the written information and give informed consent, which means agreeing to participate after understanding the details of the study.
  • Must have enough knowledge of the local language to answer the questionnaires.
  • Must have locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR exon 19 deletions or exon 21 L858R mutations. These are specific changes in the cancer cells that affect how they grow.
  • Must not be eligible for treatments aimed at curing the cancer.
  • Must have been treated with a medication called osimertinib at a dose of 80 mg once a day, with or without chemotherapy, for at least three months as part of standard care.
  • Must have shown a response to treatment based on radiologic assessment. This means that scans or images show that the cancer has either completely or partially responded to treatment, as judged by the doctor.

Who cannot join the trial?

5 criteria

  • Patients with any other type of cancer besides EGFR mutated locally advanced or metastatic non-small cell lung cancer cannot participate. EGFR is a protein that helps cells grow and divide. When it is mutated, it can cause cancer.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.
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Investigated drugs

Osimertinib is a medication used to treat a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that has certain mutations in the EGFR gene. It works by blocking the activity of the EGFR protein, which is involved in the growth and spread of cancer cells. In this clinical trial, researchers are studying whether taking osimertinib less frequently is as effective as the standard daily dosage. This could potentially make the treatment more convenient for patients while maintaining its effectiveness in controlling cancer growth.

What is already known about the treatment

Osimertinib – Osimertinib is a medication taken orally, typically in the form of a tablet, and is used to treat a specific type of lung cancer known as EGFR mutated locally advanced or metastatic non-small cell lung cancer. It is well-established in medical literature and is currently being studied to see if taking it less frequently is just as effective as the standard daily dosage. The drug works by targeting and blocking the activity of a protein called EGFR, which is involved in the growth and spread of cancer cells. Osimertinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

EGFR mutated locally advanced or metastatic non-small cell lung cancer – This type of lung cancer is characterized by mutations in the epidermal growth factor receptor (EGFR) gene, which leads to uncontrolled cell growth. 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. The progression involves the cancer cells growing and potentially spreading to other organs, which can affect their function. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the disease advances, it may lead to further complications depending on the organs affected by metastasis.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514693-47-00Estimated enrolment183 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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