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Study comparing Rilvegostomig plus chemotherapy versus Pembrolizumab plus chemotherapy for first-line treatment in patients with metastatic non-squamous lung cancer with PD-L1 expression

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 study focuses on patients with metastatic non-squamous non-small cell lung cancer whose tumors express PD-L1. The research compares two treatment combinations: a new medication called rilvegostomig plus chemotherapy versus pembrolizumab (also known as Keytruda) plus chemotherapy. The chemotherapy drugs used in both groups include cisplatin, carboplatin, and pemetrexed.

The purpose of this study is to determine if rilvegostomig combined with chemotherapy works better than pembrolizumab with chemotherapy for treating this type of lung cancer. Both treatments are given through intravenous infusion, which means they are administered directly into the bloodstream through a vein.

During the study, participants will receive either rilvegostomig or pembrolizumab along with standard chemotherapy medications. The researchers will monitor how well the treatments work and track any side effects that may occur. The study will measure how long patients live and how long they live without their cancer getting worse.

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

    Initial treatment assignment

    You will be randomly assigned to one of two treatment groups: either rilvegostomig plus chemotherapy or pembrolizumab plus chemotherapy

    The assignment is done randomly by computer, and neither you nor your doctor will know which group you are in

  2. Step 2

    Treatment administration

    You will receive medication through intravenous infusion (directly into your vein)

    The chemotherapy part of your treatment will include platinum-based drugs (either carboplatin or cisplatin)

    Treatment will continue as long as your condition does not worsen and you do not experience unacceptable side effects

  3. Step 3

    Regular monitoring

    Your doctor will regularly check your health status using CT or MRI scans to measure how your tumor is responding to treatment

    Blood tests will be performed to check your organ function and bone marrow

    Your overall physical condition will be assessed using a standard scale called ECOG performance status

  4. Step 4

    Side effect monitoring

    Any side effects you experience will be recorded and graded according to standard criteria

    Regular laboratory tests will be conducted to monitor your health

    Your vital signs will be checked at each visit

  5. Step 5

    Quality of life assessment

    You will be asked to complete questionnaires about your quality of life and physical functioning

    Your breathing symptoms will be monitored throughout the study

  6. Step 6

    Long-term follow-up

    The study will continue until March 2030

    Your health status will be monitored even after treatment ends to track long-term outcomes

Who can join the trial?

12 criteria

  • You must have non-squamous non-small cell lung cancer (NSCLC) confirmed by tissue or cell examination
  • Your cancer must be Stage IV (advanced cancer that has spread to other parts of the body) and not suitable for treatments aimed at cure
  • Your tumor must not have certain genetic changes including:
    • EGFR mutations (changes in a protein that helps cancer grow)
    • ALK rearrangements (abnormal changes in a gene that can drive cancer growth)
    • ROS1 rearrangements (another type of gene change that can affect cancer growth)
    • Your tumor must show PD-L1 expression of 1% or higher (a protein marker on cancer cells)
    • You must have at least one tumor that:
      • Has not been previously treated with radiation
      • Is at least 10 millimeters in size (or 15 millimeters for lymph nodes)
      • Can be measured accurately by CT or MRI scans
      • You must have normal organ function and adequate bone marrow function (your body's ability to produce blood cells)
      • You can be either male or female
      • You must be an adult (18 years or older)

Who cannot join the trial?

14 criteria

  • Prior treatment with any PD-1/PD-L1 inhibitor (type of immunotherapy drugs)
  • Active brain metastases (cancer that has spread to the brain) or spinal cord compression
  • History of other malignancies (other types of cancer) within 5 years before starting the study
  • Significant heart conditions including heart failure, irregular heartbeat, or recent heart attack
  • Active autoimmune disease (condition where immune system attacks healthy cells) requiring systemic treatment
  • Active or chronic infections including hepatitis B, hepatitis C, or HIV
  • History of organ transplant
  • Pregnancy or breastfeeding
  • Any serious medical condition that could interfere with study participation
  • Current participation in other clinical trials
  • Known allergy or sensitivity to study medications
  • Unable to swallow oral medications
  • Major surgery within 4 weeks before starting the study
  • Psychiatric conditions that could affect ability to comply with the study
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Investigated drugs

  • Rilvegostomig

    is a new investigational medication being studied for treating non-small cell lung cancer. It belongs to a class of drugs that help the immune system fight cancer cells. It is given in combination with chemotherapy as a first-line treatment for patients whose cancer has spread to other parts of the body.

  • Pembrolizumab

    is an immunotherapy medication that works by helping the immune system detect and fight cancer cells. It is already approved for treating various types of cancer, including non-small cell lung cancer. In this trial, it is also given with chemotherapy.

  • Platinum-based Chemotherapy

    refers to standard cancer treatment medications that contain platinum. These medications work by damaging the DNA of cancer cells, which prevents them from growing and dividing. They are commonly used to treat many types of cancer, including lung cancer.

What is already known about the treatment

  • Rilvegostomig

    An investigational immunotherapy medication administered intravenously, currently being studied in Phase III clinical trials for the treatment of metastatic non-squamous non-small cell lung cancer with PD-L1 expression. The drug works by targeting specific immune pathways to enhance the body's natural ability to fight cancer cells, belonging to a class of novel immunotherapeutic agents. It is being evaluated in combination with platinum-based chemotherapy as a first-line treatment option.

  • Pembrolizumab

    An established immunotherapy medication administered through intravenous infusion, approved for treating various types of cancer including non-small cell lung cancer. It works by blocking the PD-1 pathway, which helps the immune system detect and fight cancer cells, and belongs to the class of PD-1 inhibitors. The medication is commonly used in combination with chemotherapy as a first-line treatment for metastatic non-squamous non-small cell lung cancer in patients whose tumors express PD-L1.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) - A type of lung cancer that begins in the large cells of the lung, different from small cell lung cancer. The disease typically develops when abnormal cells in the lungs begin to grow uncontrollably and form tumors. Non-squamous NSCLC specifically affects the non-flat (glandular) cells of the lung tissue. When the cancer spreads (metastasizes) beyond the lungs to other parts of the body, it is called metastatic NSCLC. The disease can affect lung function and may cause symptoms such as persistent cough, chest pain, and shortness of breath. PD-L1 expressing tumors have a specific protein on their surface that plays a role in how the cancer interacts with the body's immune system.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515008-38-00Protocol codeD702FC00001Estimated enrolment1 160 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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