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Study of Different Dosing Schedules of Osimertinib in Patients with EGFR Mutated Advanced or Metastatic Non-Small Cell Lung Cancer

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What is this trial about?

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

This study involves patients with non-small cell lung cancer that has spread to other parts of the body or grown locally in an advanced way and has a specific change in the cancer cells called an EGFR mutation. The treatment being studied is osimertinib, which is also known by its code name AZD9291, and is given as tablets taken by mouth. This medicine is already being used as a standard treatment for this type of lung cancer.

The purpose of this study is to find out if taking osimertinib less often than the usual daily dose works just as well as taking it every day. Patients in this study will already have been taking osimertinib once daily for at least three months and will have shown a positive response to the treatment, meaning their cancer has gotten smaller or stayed stable. The study will compare how well the cancer stays under control when patients continue taking the medicine every day versus taking it less frequently.

During the study, patients will continue their treatment with osimertinib and will be monitored regularly to see how the cancer responds and to check for any side effects. The study will also look at how the treatment affects patients' daily lives and overall well-being, as well as the costs associated with different dosing schedules. Patients will be asked to complete questionnaires about their symptoms and quality of life throughout the study period, which is expected to last up to two years for each participant.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment continuation phase

    At the start of the trial, you will continue taking osimertinib as prescribed. This medication is the active substance in TAGRISSO 80 mg film-coated tablets.

    The standard treatment involves taking 80 mg once daily by mouth. You must have already been taking this medication for at least three months before entering the trial.

    The trial will assess whether extending the time between doses works as well as the standard daily dosing schedule.

  2. Step 2

    Regular monitoring and assessments

    Throughout the trial, your condition will be monitored through regular imaging scans to check how the cancer is responding to treatment.

    You will be asked to complete questionnaires about any side effects you experience and your quality of life.

    These questionnaires will help track how you are feeling during the treatment period.

  3. Step 3

    Medication adherence tracking

    The trial will monitor how consistently you take your medication as prescribed.

    This information helps determine whether the treatment schedule is practical for patients to follow.

  4. Step 4

    Ongoing treatment period

    You will continue receiving treatment according to the dosing schedule assigned to you in the trial.

    The trial will continue monitoring your progression-free survival, which means the length of time during and after treatment that your cancer does not get worse.

    The trial will also track your overall survival, which is the length of time you remain alive after starting the treatment.

  5. Step 5

    Special monitoring for brain metastases

    During the trial, specific attention will be paid to whether cancer spreads to the central nervous system, which includes the brain and spinal cord.

    This monitoring occurs through imaging scans performed at regular intervals.

  6. Step 6

    Economic and quality of life evaluation

    Throughout the trial, information will be collected about the economic aspects of your treatment.

    You will continue to complete questionnaires about your quality of life to assess how the treatment affects your daily activities and well-being.

  7. Step 7

    Long-term follow-up

    The trial will continue following your progress over an extended period.

    Regular assessments will continue to track the effectiveness of the treatment and any side effects you may experience.

    The estimated duration of the trial extends until October 2031.

Who can join the trial?

8 criteria

  • You must be 18 years of age or older
  • You must be able to understand written information and give your informed consent, which means you agree to participate in the study after receiving all necessary information
  • You must have sufficient knowledge of the local language to answer questionnaires
  • You must have locally advanced or metastatic non-small cell lung cancer, which is a type of lung cancer that has either spread within the chest or to other parts of the body
  • Your cancer must have specific EGFR mutations, which are changes in a gene called EGFR, specifically exon 19 deletions or exon 21 L858R mutations
  • Your cancer must not be suitable for treatment aimed at curing the disease
  • You must have been receiving treatment with osimertinib 80 mg once daily, which is a medication taken by mouth, with or without chemotherapy, for at least three months as part of your standard care
  • You must have shown a response to treatment on imaging scans, meaning your tumors have either disappeared completely, gotten smaller, or shown improvement according to your doctor's assessment

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed information, it is not possible to list the specific conditions or situations that would prevent participation in this clinical trial
  • Generally, exclusion criteria may include things like other serious health conditions, certain medications being taken, or previous treatments, but these specific details are not available in the provided information
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Investigated drugs

Osimertinib is a medication used to treat a specific type of lung cancer called non-small cell lung cancer. It works by targeting and blocking abnormal proteins in cancer cells that have a mutation in a gene called EGFR. This medication helps slow down or stop the growth of cancer cells. In this trial, researchers are testing whether taking this medication less frequently works as well as taking it on the standard schedule.

What is already known about the treatment

Osimertinib – Osimertinib is a medication taken by mouth in tablet form, typically once daily, used to treat a specific type of lung cancer called non-small cell lung cancer that has spread or grown locally and contains certain genetic changes (EGFR mutations). This drug works by blocking abnormal proteins produced by mutated EGFR genes, which are responsible for helping cancer cells grow and multiply uncontrollably. It belongs to a class of medications known as targeted therapy or tyrosine kinase inhibitors, which specifically attack cancer cells while causing less harm to normal cells compared to traditional chemotherapy. Osimertinib is an approved and established treatment option that is widely recognized in current medical practice and scientific literature for managing this particular form of lung cancer.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer is a type of cancer that begins in the lungs and accounts for the majority of lung cancer cases. The disease occurs when cells in the lung tissue grow abnormally and uncontrollably, forming tumors. In locally advanced stages, the cancer has spread to nearby tissues or lymph nodes but remains in the chest area. When the disease becomes metastatic, cancer cells spread beyond the lungs to other parts of the body such as bones, liver, brain, or other organs. Some cases of this cancer involve mutations in the EGFR gene, which causes cells to grow and divide more rapidly. The disease progressively interferes with normal lung function and can affect multiple organ systems as it spreads.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514693-47-01Estimated enrolment283 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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