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Study to Compare Datopotamab Deruxtecan with Rilvegostomig or Alone Against Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with High PD-L1 Levels

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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 treatments for a type of lung cancer known as non-squamous non-small cell lung cancer (NSCLC). This specific form of lung cancer is characterized by high levels of a protein called PD-L1. The study will explore the effectiveness and safety of a new treatment combination involving two medications: Datopotamab deruxtecan (also known as Dato-DXd) and Rilvegostomig (also known as AZD2936). Additionally, the study will compare these treatments to another medication called Pembrolizumab, which is already used in treating this type of cancer.

The purpose of the study is to determine if the combination of Dato-DXd and Rilvegostomig, or Rilvegostomig alone, is more effective than Pembrolizumab in treating patients with advanced NSCLC. Participants in the study will receive one of these treatments, and some may receive a placebo. The study will monitor the progress of the disease and the overall health of the participants over time. The treatments will be administered through an intravenous infusion, which means they will be given directly into a vein.

Throughout the study, participants will have regular check-ups to assess their response to the treatment and to monitor any side effects. The study aims to provide valuable information on how these treatments can help manage NSCLC and improve the quality of life for those affected by this condition. The trial is expected to continue for several years, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatments being studied.

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 a diagnosis of non-squamous non-small cell lung cancer (NSCLC) with high PD-L1 expression.

    A tumor sample is required to determine PD-L1 and TROP2 status, along with other biomarkers.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to one of the treatment groups: either datopotamab deruxtecan with rilvegostomig, rilvegostomig alone, or pembrolizumab alone.

    The assignment is open-label, meaning both the participant and the research team know which treatment is being administered.

  3. Step 3

    Treatment administration

    For those receiving datopotamab deruxtecan and rilvegostomig, both medications are administered intravenously as a solution for infusion.

    Participants receiving pembrolizumab also receive it intravenously as a solution for infusion.

    The frequency and duration of administration are determined by the study protocol and the participant's response to treatment.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the progression of the disease and the participant's overall health.

    Assessments include imaging tests to evaluate tumor response and blood tests to monitor organ function and bone marrow reserve.

  5. Step 5

    Follow-up

    Participants continue to be monitored for progression-free survival (PFS) and overall survival (OS).

    Additional assessments include the evaluation of lung cancer symptoms, quality of life, and any side effects experienced during the trial.

Who can join the trial?

8 criteria

  • The patient must have a type of lung cancer called **non-squamous non-small cell lung cancer (NSCLC)**, which has been confirmed through specific tests.
  • The cancer must be at an advanced stage, specifically **Stage IIIB, IIIC, or Stage IV**, meaning it has spread and cannot be treated with surgery or combined treatments like chemotherapy and radiation.
  • The patient should not have certain genetic changes in their cancer, such as **EGFR mutations** or changes in **ALK** and **ROS1** genes, which are known to have specific treatments available.
  • The patient must provide a sample of their tumor to check for specific markers, including **PD-L1** and **TROP2**, which are proteins that can be found on cancer cells.
  • The patient's tumor must show a high level of **PD-L1 expression**, which is a measure of how much of this protein is present, using a specific test called the **VENTANA PD-L1 (SP263) Assay**.
  • There must be at least one area of cancer that has not been treated with radiation and can be measured for changes during the study.
  • The patient should have a good general health status, as measured by the **ECOG performance status**, which should be 0 or 1. This means the patient is fully active or has some symptoms but can still carry out light work.
  • The patient must have enough healthy blood cells and properly working organs, as confirmed by tests done within 7 days before starting the study treatment.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not the specific type being studied.
  • Patients who have certain genetic changes in their cancer that can be targeted by specific treatments.
  • Patients who have received certain treatments for their cancer in the past that might affect the study results.
  • Patients with serious health conditions that could make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of severe allergic reactions to similar medications.
  • Patients with active infections that require treatment.
  • Patients with certain heart conditions that could be worsened by the study treatment.
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Investigated drugs

  • Datopotamab Deruxtecan (Dato-DXd)

    is an investigational drug being studied for its potential to treat certain types of lung cancer. It is designed to target and deliver chemotherapy directly to cancer cells, which may help to reduce the growth of tumors.

  • Rilvegostomig (AZD2936)

    is another investigational medication in this trial. It is being tested both on its own and in combination with Dato-DXd to see if it can improve outcomes for patients with specific types of lung cancer.

  • Pembrolizumab

    is an approved medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. In this trial, it is being used as a comparison to evaluate the effectiveness of the new investigational treatments.

What is already known about the treatment

  • Datopotamab Deruxtecan (Dato-DXd)

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating locally-advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high PD-L1 expression. It is an antibody-drug conjugate that targets the TROP2 protein, delivering a cytotoxic agent directly to cancer cells, thereby inhibiting their growth. Datopotamab Deruxtecan is classified as an antineoplastic agent and is being evaluated for its potential to improve progression-free survival and overall survival in patients with specific cancer biomarkers.

  • Rilvegostomig (AZD2936)

    This medication is administered intravenously and is currently under investigation in clinical trials for its use in treating locally-advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high PD-L1 expression. It functions as an immune checkpoint inhibitor, blocking the interaction between PD-1 and PD-L1, which helps the immune system recognize and attack cancer cells. Rilvegostomig is classified as an immunotherapy agent and is being studied for its potential to enhance the body's immune response against cancer.

  • Pembrolizumab

    This medication is administered intravenously and is an established treatment for various types of cancer, including non-squamous non-small cell lung cancer (NSCLC) with high PD-L1 expression. It works as an immune checkpoint inhibitor by blocking the PD-1 pathway, allowing the immune system to better detect and destroy cancer cells. Pembrolizumab is classified as an immunotherapy agent and is widely used to improve survival rates in patients with certain types of cancer.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. NSCLC is often diagnosed at an advanced stage, where it may have spread beyond the lungs. The disease progresses as cancer cells invade nearby tissues and potentially metastasize to other parts of the body. In cases with high PD-L1 expression, the cancer cells may evade the immune system more effectively. This type of NSCLC does not have specific genetic mutations that can be targeted with certain therapies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505077-32-00Protocol codeD7632C00001Estimated enrolment675 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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