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Study on Datopotamab Deruxtecan and Osimertinib for Patients with Advanced Non-Small Cell Lung Cancer After Osimertinib Treatment

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), specifically in patients whose cancer has progressed after treatment with a medication called osimertinib. The study aims to evaluate the effectiveness and safety of a new treatment called Datopotamab deruxtecan, both on its own and in combination with osimertinib, compared to traditional chemotherapy treatments. Chemotherapy in this study includes drugs like carboplatin, pemetrexed, and cisplatin, which are commonly used to treat cancer by killing or stopping the growth of cancer cells.

Participants in the study will be randomly assigned to receive either Datopotamab deruxtecan alone, Datopotamab deruxtecan with osimertinib, or a combination of the chemotherapy drugs. The study will monitor how long patients live without their cancer getting worse, which is known as progression-free survival. It will also look at overall survival, which is the length of time patients live after starting the study, regardless of whether their cancer progresses. The study will also assess how the treatments affect symptoms and quality of life.

The trial is designed to provide important information about whether Datopotamab deruxtecan, alone or with osimertinib, is more effective than the standard chemotherapy options for patients with advanced NSCLC. This information could help improve treatment options for people with this type of lung cancer in the future.

The research process

The trial runs in 6 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, participants will be randomly assigned to one of the treatment groups. This means that the treatment you receive will be determined by chance, like flipping a coin. This process ensures that the study results are fair and reliable.

  2. Step 2

    Treatment with Dato-DXd

    If assigned to the Dato-DXd group, you will receive an intravenous infusion of Datopotamab deruxtecan. This is a medication given directly into your vein through a needle. The frequency and duration of this treatment will be explained by the study team.

  3. Step 3

    Treatment with Dato-DXd and Osimertinib

    If assigned to the combination group, you will receive both Datopotamab deruxtecan through an intravenous infusion and Osimertinib in the form of oral tablets. The tablets are taken by mouth, and the study team will provide instructions on how often and how long to take them.

  4. Step 4

    Treatment with platinum-based chemotherapy

    If assigned to the chemotherapy group, you will receive a combination of Carboplatin or Cisplatin and Pemetrexed. These medications are administered through intravenous infusion. The study team will inform you about the schedule and duration of these treatments.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, regular monitoring will be conducted to assess your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies. The study team will provide details on the frequency and type of monitoring required.

  6. Step 6

    Completion of the study

    At the end of the study, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment. The study team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).
  • Must have documented information about specific EGFR mutations (changes in the epidermal growth factor receptor gene) that are known to respond to certain treatments.
  • Must have shown disease progression outside the brain after previous treatment with osimertinib (a type of cancer medication) as the most recent treatment.
  • Must have had two or fewer previous treatments with EGFR tyrosine kinase inhibitors (TKIs), with osimertinib being the only allowed third-generation EGFR TKI.
  • Must have at least one tumor that has not been treated with radiation and can be accurately measured at the start of the study.
  • Must have a performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have adequate bone marrow reserve and organ function within 7 days before starting the study.
  • Both male and female participants are eligible.

Who cannot join the trial?

3 criteria

  • Patients with a type of lung cancer that is not non-squamous non-small cell lung cancer (NSCLC) cannot participate.
  • Patients who are not within the specified age range for the 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

  • Dato-DXd

    is a medication being studied for its potential to treat a type of lung cancer known as non-small cell lung cancer. This medication is designed to target and deliver a powerful anti-cancer drug directly to the cancer cells, which may help to stop the cancer from growing and spreading. In this trial, researchers are testing whether Dato-DXd can work better than standard chemotherapy treatments.

  • Osimertinib

    is a medication that is already used to treat certain types of lung cancer, particularly those with specific genetic mutations. It works by blocking the signals that tell cancer cells to grow. In this study, osimertinib is being combined with Dato-DXd to see if the combination can be more effective than chemotherapy in treating lung cancer that has progressed after previous treatment with osimertinib alone.

  • Platinum-based Doublet Chemotherapy

    is a standard treatment for lung cancer that uses two chemotherapy drugs together. These drugs work by killing cancer cells or stopping them from dividing. In this trial, the effectiveness of platinum-based doublet chemotherapy is being compared to the new treatment options involving Dato-DXd, with or without osimertinib, to see which approach is more effective in controlling the cancer.

What is already known about the treatment

  • Dato-DXd

    Dato-DXd is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating non-squamous non-small cell lung cancer (NSCLC) that has progressed after treatment with osimertinib. The main therapeutic indication for Dato-DXd is to improve progression-free survival in patients with this type of lung cancer. At the molecular level, Dato-DXd works by delivering a chemotherapy drug directly to cancer cells, which helps to kill them while minimizing damage to healthy cells. It is classified as an antibody-drug conjugate, a type of targeted cancer therapy.

  • Osimertinib

    Osimertinib is taken orally in the form of a tablet. It is an established medication used in the treatment of non-small cell lung cancer (NSCLC) with specific genetic mutations. In the context of the clinical trial, it is being combined with Dato-DXd to assess its effectiveness in improving progression-free survival compared to standard chemotherapy. Osimertinib works by blocking certain proteins that promote the growth of cancer cells, specifically targeting mutations in the epidermal growth factor receptor (EGFR). It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Non-squamous non-small cell lung cancer (NSCLC) – Non-squamous non-small cell lung cancer is a type of lung cancer that originates in the epithelial cells of the lung, which are not of the squamous type. It is characterized by the uncontrolled growth of abnormal cells in the lung tissues, leading to the formation of tumors. As the disease progresses, these tumors can grow larger and may spread to other parts of the body, a process known as metastasis. The progression of the disease can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. Over time, the cancer can invade nearby tissues and organs, further complicating the condition. The rate of progression can vary significantly among individuals, influenced by factors such as genetic mutations and overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511362-37-00Protocol codeD516KC00001Estimated enrolment744 patientsSponsorAstraZeneca AB

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