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Study on the Effectiveness of Osimertinib for Patients with EGFR Mutant Non-Small Cell Lung Cancer Based on TP53 Mutation Status

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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 mutant non-small cell lung cancer (NSCLC). This specific form of lung cancer involves changes in the EGFR gene, which can affect how cancer cells grow. The study is particularly interested in understanding how another gene, called TP53, influences the effectiveness of the treatment. The treatment being tested in this study is a medication called osimertinib, which is also known by its code name AZD9291. Osimertinib is taken as a film-coated tablet and is designed to target and block the activity of the EGFR gene mutations in cancer cells.

The purpose of this study is to evaluate how well osimertinib works in patients who have not received any previous treatment for their advanced EGFR mutant NSCLC. Participants in the study will take osimertinib orally, and the study will monitor their progress over time. The study aims to understand how the presence of the TP53 mutation affects the treatment's success in controlling the cancer. The trial will follow patients to see how long they can live without the cancer getting worse, which is known as progression-free survival.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the cancer's response to the treatment. These tests may include imaging techniques like computed tomography (CT) or magnetic resonance imaging (MRI) to measure the size of the cancer. The study will help gather important information on the effectiveness of osimertinib for patients with this specific type of lung cancer, potentially leading to better treatment options in the future.

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

    Initial consent and eligibility

    You will provide informed consent, which means you agree to participate in the study after understanding all the details.

    You must be over 18 years old and have a specific type of lung cancer called EGFR mutant NSCLC.

    You will need to provide a sample of your tumor tissue for analysis.

    You should not have received treatment for your advanced lung cancer before, except for certain therapies completed at least 6 months ago.

    Your health status will be assessed to ensure you can participate, including a check that you have a life expectancy of at least 12 weeks.

  2. Step 2

    Medication administration

    You will start taking a medication called osimertinib, which comes in the form of TAGRISSO 80 mg film-coated tablets.

    The medication is taken orally, meaning you will swallow the tablet.

    You will take the tablet once daily, at the same time each day, for the duration of the study.

  3. Step 3

    Regular monitoring and visits

    You will have scheduled visits to the clinic for monitoring your health and the effects of the medication.

    These visits will include examinations and possibly imaging tests like CT or MRI scans to measure the size of your tumor.

    You will be required to comply with all scheduled visits and procedures as outlined in the study protocol.

  4. Step 4

    Follow-up and study completion

    After completing the treatment phase, you will continue to be monitored for a period to assess the long-term effects of the medication.

    The study is expected to end by December 30, 2025, but your participation may end earlier depending on your health and the study's progress.

Who can join the trial?

11 criteria

  • Provide informed consent before any study-specific procedures.
  • Must be a male or female over 18 years of age.
  • Have locally advanced or metastatic **EGFR mutant NSCLC** (a type of lung cancer) that cannot be treated with surgery or radiotherapy. Must have a specific genetic change called **EGFR exon 19 deletion** or **exon 21 p. L858R**.
  • Provide a sample of tumor tissue for analysis.
  • Must not have received treatment for locally advanced or metastatic NSCLC and should be eligible for first-line treatment with **osimertinib** (a cancer medication). Previous treatments like chemotherapy or radiotherapy are allowed if they ended at least 6 months before joining the study.
  • Have a **World Health Organization (WHO) performance status** of 0-1, meaning you are fully active or have some symptoms but do not need bed rest.
  • Have a life expectancy of at least 12 weeks.
  • Females must use adequate birth control, not be breastfeeding, and have a negative pregnancy test if they can have children. They must show they cannot have children by being post-menopausal or having had certain surgeries.
  • Male patients should agree to use barrier contraception.
  • Be willing and able to follow the study protocol, including treatment, visits, and examinations.
  • Have at least one measurable lesion (a tumor that can be measured) that has not been treated with radiation, which is at least 10 mm in size (or 15 mm for lymph nodes) and can be measured accurately with a CT or MRI scan.

Who cannot join the trial?

4 criteria

  • Patients who do not have a mutation in the EGFR gene. EGFR stands for Epidermal Growth Factor Receptor, which is a protein that helps cells grow and divide.
  • Patients with a specific mutation in the TP53 gene. The TP53 gene helps control cell division and can prevent cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Osimertinib is a medication used in this clinical trial to treat patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that has certain genetic changes, specifically mutations in the EGFR gene. This medication works by targeting and blocking the activity of the EGFR protein, which is involved in the growth and spread of cancer cells. By inhibiting this protein, osimertinib can help slow down or stop the progression of the cancer, providing a potential treatment option for patients with this type of lung cancer.

What is already known about the treatment

Osimertinib – Osimertinib is a medication taken orally, usually in the form of a tablet, and is currently being studied for its effectiveness in treating patients with a specific type of lung cancer known as EGFR mutant non-small cell lung cancer (NSCLC), particularly in those with a TP53 mutation. It is well-regarded in medical literature for its targeted action against cancer cells with these mutations. The main use of osimertinib is to help manage and slow the progression of this type of lung cancer. At the molecular level, osimertinib works by blocking certain proteins that promote the growth of cancer cells, specifically targeting the epidermal growth factor receptor (EGFR) mutations. It is classified as a tyrosine kinase inhibitor, which is a type of targeted cancer therapy.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease progresses through stages, starting from a localized tumor to more advanced stages where it spreads to lymph nodes and other organs. As it advances, symptoms may include persistent cough, chest pain, and difficulty breathing. The progression rate can vary, and it often depends on genetic factors, such as mutations in the EGFR and TP53 genes. Understanding these mutations can help in studying the disease's behavior and progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517424-18-00Estimated enrolment54 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).