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Study on the Safety and Effectiveness of Osimertinib and Datopotamab Deruxtecan for Patients with Advanced EGFR Mutation-Positive 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

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC) that has a specific change in the EGFR gene. This change is called a mutation, and it can make the cancer grow. The study is looking at how well a treatment works for people with this kind of lung cancer. The treatment involves using a medication called osimertinib, which is also known by its code name AZD9291. Osimertinib is a type of drug that targets the EGFR mutation to help stop the cancer from growing. The study will also test osimertinib in combination with another drug called datopotamab deruxtecan, which is given as an infusion into a vein.

The purpose of the study is to see if the combination of osimertinib and datopotamab deruxtecan works better than osimertinib alone in treating this type of lung cancer. Participants in the study will be randomly assigned to receive either the combination treatment or osimertinib by itself. The study will monitor how the cancer responds to the treatments over time. Participants will receive regular check-ups and assessments to track their progress and any changes in their condition.

The study will continue for several years to gather enough information about the effectiveness and safety of the treatments. The goal is to find out if the combination of these medications can provide better outcomes for people with advanced or metastatic NSCLC that has the EGFR mutation. This research could help improve treatment options for patients with this type of lung cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of lung cancer, and genetic mutations.

    A sample of tumor tissue is required to confirm the presence of specific genetic mutations.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving osimertinib alone, and the other receiving a combination of osimertinib and datopotamab deruxtecan.

  3. Step 3

    Treatment administration

    For those receiving osimertinib alone, the medication is taken orally in the form of film-coated tablets, with a dosage of either 80 mg or 40 mg, as prescribed by the study protocol.

    Participants in the combination group receive osimertinib orally and datopotamab deruxtecan intravenously as a solution for infusion.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the progression of the disease and the effectiveness of the treatment.

    Assessments include imaging tests to measure tumor size and check for any new lesions.

  5. Step 5

    End of treatment

    The treatment continues until there is evidence of disease progression or unacceptable side effects occur.

    Participants are followed up to evaluate overall survival and progression-free survival.

Who can join the trial?

7 criteria

  • The participant must be at least 18 years old. If the participant is from Japan, they must be at least 20 years old.
  • The participant must have a type of lung cancer called **nonsquamous non-small cell lung cancer (NSCLC)**, which has been confirmed through specific medical tests.
  • The lung cancer must be at an advanced stage, specifically Stage IIIB, IIIC, or Stage IV, or it must have come back after treatment. This means the cancer cannot be cured with surgery or a combination of chemotherapy and radiation at the time of joining the study.
  • The participant must not have received certain treatments before, specifically **EGFR TKIs** or other treatments for advanced lung cancer.
  • The participant's tumor must have one of the two common **EGFR mutations** that respond well to a specific type of treatment. These mutations are called **Ex19del** or **L858R**. The tumor can have these mutations alone or with other EGFR mutations.
  • The participant must provide a sample of their tumor tissue, which has not been stained, from a previous test. This sample is needed to confirm the presence of the EGFR mutation.
  • The participant must have at least one tumor area that has not been treated with radiation before. This area must be measurable and meet specific size requirements using a CT or MRI scan. The longest part of the tumor must be at least 10 mm, except for lymph nodes, which must be at least 15 mm in the shortest part.

Who cannot join the trial?

4 criteria

  • Patients who do not have a specific type of lung cancer called EGFR mutation-positive, locally advanced or metastatic non-squamous non-small cell lung cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • Osimertinib

    is a medication used to treat certain types of 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 or stop the growth of cancer cells.

  • Datopotamab Deruxtecan (Dato-DXd)

    is an investigational drug being studied for its potential to treat cancer. It is designed to deliver chemotherapy directly to cancer cells, which may help to kill the cancer cells while minimizing damage to normal cells. In this trial, it is being tested in combination with osimertinib to see if it can improve treatment outcomes for patients with EGFR mutation-positive NSCLC.

What is already known about the treatment

  • Osimertinib

    Osimertinib is administered orally in tablet form and is currently approved for use in treating certain types of lung cancer. It is primarily used for patients with non-small cell lung cancer that has specific mutations in the epidermal growth factor receptor (EGFR). The medication works by inhibiting the activity of the 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.

  • Datopotamab Deruxtecan (Dato-DXd)

    Datopotamab Deruxtecan is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating lung cancer. It is being investigated for use in combination with osimertinib for patients with EGFR mutation-positive non-small cell lung cancer. The drug works by delivering a cytotoxic agent directly to cancer cells, thereby inhibiting their growth and survival. Datopotamab Deruxtecan is classified as an antibody-drug conjugate, which combines an antibody with a chemotherapy drug to target cancer cells more precisely.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC is known for its slower growth compared to small cell lung cancer, and it often spreads to other parts of the body. The disease can be locally advanced, meaning it has spread to nearby tissues, or metastatic, indicating it has spread to distant organs. A specific mutation in the epidermal growth factor receptor (EGFR) can drive the progression of this cancer, influencing its behavior and response to certain treatments.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509883-89-00Protocol codeD516NC00001Estimated enrolment568 patientsSponsorAstraZeneca AB

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