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Phase III Randomized Study of Rilvegostomig vs. Pembrolizumab with Platinum-based Chemotherapy in PD-L1 Expressing Metastatic Squamous NSCLC

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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 metastatic squamous non-small cell lung cancer (NSCLC) that shows a specific protein called PD-L1. The study is comparing two treatments: one involves a medication called rilvegostomig (also known by its code name AZD2936), and the other uses a medication called pembrolizumab. Both treatments are combined with chemotherapy, which is a common cancer treatment that uses drugs to kill cancer cells.

The purpose of the study is to see how effective and safe these treatments are for patients with this type of lung cancer. Participants will receive either rilvegostomig or pembrolizumab, along with chemotherapy drugs such as carboplatin and paclitaxel. The study will monitor how long patients live and how long they remain free from cancer progression, which means the cancer does not get worse. The study will also look at other factors like the overall response to the treatment and any side effects experienced.

Participants will receive their treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over several months, and participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to find out which combination of treatments works best for this type of lung cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization to treatment arm

    After joining, you are assigned to receive either rilvegostomig plus chemotherapy or pembrolizumab plus chemotherapy. the assignment is decided by the study system and is not influenced by you.

  2. Step 2

    Initial treatment day

    On the first day of treatment, you receive an intravenous infusion (medicine delivered through a vein) of the chemotherapy drugs:

    carboplatin 6 mg, paclitaxel 200 mg per square meter of body surface area, or the albumin‑bound form paclitaxel albumin‑bound 100 mg per square meter, depending on the protocol.

    At the same time, you receive the study drug assigned to you:

    If you are in the rilvegostomig arm, a dose of 0 mg is given as an intravenous infusion;

    If you are in the pembrolizumab arm, a dose of 200 mg is given as an intravenous infusion.

  3. Step 3

    Oral background medication

    You take mycophenolate mofetil by mouth at a dose of 3 g each day. this medication is taken continuously while you remain in the study.

  4. Step 4

    Additional background infusion

    You receive an intravenous infusion of infliximab at a dose of 5 mg per kilogram of body weight. the timing of this infusion follows the study schedule.

  5. Step 5

    Repeated treatment cycles

    The chemotherapy and the assigned study drug are repeated in cycles according to the study schedule, typically every few weeks.

    Each cycle includes the same doses of carboplatin, paclitaxel (or paclitaxel albumin‑bound) and the study drug (rilvegostomig or pembrolizumab).

    Oral mycophenolate mofetil continues daily, and any scheduled infliximab infusions are given as defined by the protocol.

  6. Step 6

    Monitoring and assessments

    Before each treatment cycle, you undergo safety checks that may include blood tests, vital‑sign measurements, and performance‑status evaluation.

    These assessments help determine whether the next cycle can be given safely.

  7. Step 7

    End of treatment

    Treatment stops when the study protocol defines the end, when disease progression is observed, or when side effects become unacceptable.

    After the last treatment, you continue to be followed for overall survival and disease‑free time until the study end date of 2029‑10‑08.

Who can join the trial?

8 criteria

  • Have a type of lung cancer called squamous non‑small cell lung cancer (NSCLC) that was confirmed by looking at tissue or cells under a microscope.
  • The cancer must be at Stage IV (meaning it has spread to other parts of the body) and cannot be cured with surgery or radiation.
  • No known genetic changes (mutations) that would allow the use of other specially‑targeted medicines.
  • Provide a tumor sample that shows the protein PD‑L1 is present on at least 1 % of cancer cells (PD‑L1 helps the immune system recognize the tumor).
  • Have at least one tumor spot that has not been treated with radiation, can be seen on a scan, and is large enough to measure (at least 10 mm in its longest side, or a lymph node at least 15 mm in its short side) using a CT or MRI scan.
  • Have healthy enough organ and bone marrow function (the organs and the part of the blood‑forming system that makes blood cells must work well enough to handle treatment).
  • Be an adult (usually 18 years or older) and can be either male or female.
  • The study can include participants who are considered vulnerable, as long as they meet all the other requirements.

Who cannot join the trial?

9 criteria

  • You cannot join if your cancer includes small cell or neuroendocrine types, which are different from the type being studied.
  • You cannot join if you have cancer that has spread to the brain (brain metastases) unless the spots cause no symptoms, are stable, and you have not needed medicines like steroids (anti‑inflammation drugs) or anticonvulsants (seizure medicines) for at least 7 days before the study starts. Also, at least 2 weeks must have passed since any brain radiation or surgery, and you must have fully recovered from any side‑effects of that treatment.
  • You cannot join if you have already received any systemic therapy (treatment that travels through the whole body) for advanced or metastatic non‑small cell lung cancer.
  • You cannot join if you have previously been treated with medicines that block PD‑1 or PD‑L1, which are types of immune‑checkpoint inhibitors.
  • You cannot join if you have ever received a drug that blocks TIGIT or any other experimental therapy that targets the immune system’s regulatory pathways.
  • You cannot join if you have had another main cancer (primary malignancy) unless that cancer was treated with a cure‑intent, has been disease‑free for at least 2 years, and is considered low risk for coming back.
  • You cannot join if you have an active or past autoimmune or inflammatory disease that needs ongoing treatment with steroids or other medicines that suppress the immune system.
  • You cannot join if you have a weakened immune system (primary immunodeficiency) or any current serious infection.
  • You cannot join if you have an active infection with tuberculosis (TB).
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Investigated drugs

  • Paclitaxel

    is a chemotherapy drug given through an IV. In this study it is used as part of the standard platinum‑based chemotherapy regimen to help kill cancer cells in the lungs.

  • Paclitaxel albumin‑bound (Abraxane)

    is a version of paclitaxel that is attached to a protein (albumin) to help the medication get into the tumor more easily. It is also given by IV and is combined with other chemotherapy drugs to treat the lung cancer.

  • Mycophenolate mofetil

    is an oral medication that suppresses the immune system. In the trial it is used as a background therapy to help control any immune‑related side effects that may arise from the cancer treatments.

  • Rilvegostomig

    is an experimental IV infusion being tested as a new cancer treatment. It is given together with the standard platinum‑based chemotherapy to see if it improves survival compared with the current standard therapy.

  • Pembrolizumab (Keytruda)

    is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. In this study it is given by IV as the comparator treatment, combined with the same chemotherapy, to see how it works against the new experimental drug.

  • Carboplatin

    is a chemotherapy drug administered through an IV. It is a core part of the platinum‑based chemotherapy regimen used for all patients in the trial, working together with other drugs to stop cancer growth.

What is already known about the treatment

  • Paclitaxel

    This drug is given by intravenous infusion, where it is slowly injected into a vein. It is an established chemotherapy medicine widely used and described in many medical studies. It is mainly used to treat various cancers, including lung cancer. It works by keeping cell structures called microtubules from breaking down, which stops cancer cells from dividing, and it belongs to the taxane class of anti‑cancer agents.

  • Mycophenolate mofetil

    This medication is taken orally as a tablet or capsule. It is an approved immunosuppressant that has been used for many years, especially after organ transplants. It is mainly prescribed to prevent the body from rejecting a transplanted organ. It blocks an enzyme needed for making DNA in immune cells, reducing their activity, and it is classified as an antimetabolite immunosuppressive drug.

  • Paclitaxel albumin‑bound (Abraxane)

    The drug is supplied as a powder that is mixed with liquid and given by intravenous infusion. It is a commercially approved formulation of paclitaxel and is listed in current medical literature for several solid tumors. It is used to treat breast, lung and pancreatic cancers. It delivers paclitaxel attached to albumin particles, which helps the drug enter tumors more easily, and it is also a taxane‑type chemotherapy.

  • Rilvegostomig

    This agent is administered as an intravenous solution that is infused into a vein. It is still an investigational drug and is being studied in clinical trials. It is being tested for use together with chemotherapy in patients with metastatic squamous non‑small cell lung cancer that shows PD‑L1. It is designed to bind to a specific protein on cancer cells and block signals that help the tumor grow, and it is classified as an experimental monoclonal antibody.

  • Pembrolizumab

    The medication is provided as a concentrate for intravenous infusion. It is an approved cancer immunotherapy that appears in many recent medical publications. It is used to treat several cancers, including lung cancer with PD‑L1 expression. It works by attaching to the PD‑1 receptor on immune cells, releasing the brake on the immune system so it can attack cancer, and it belongs to the class of checkpoint inhibitor antibodies.

  • Carboplatin

    This drug is given by intravenous infusion, usually through a needle placed in a vein. It is a long‑standing, approved chemotherapy drug with extensive literature support. It is commonly used to treat lung, ovarian and other solid tumors. It damages the DNA of cancer cells by forming bonds that prevent the cells from repairing themselves, and it is classified as a platinum‑based chemotherapy agent.

Investigated diseases

Metastatic squamous non‑small cell lung cancer expressing PD‑L1 - It is a type of lung cancer that starts in the flat cells lining the airways and has spread beyond the original lung. The cancer cells show a protein called PD‑L1 on their surface. As the disease progresses, new tumors can appear in other parts of the body such as the bones, brain, or liver. The growth of the tumors may cause increasing coughing, shortness of breath, or chest discomfort. Over time, the cancer can affect overall lung function and may lead to more widespread disease.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514281-39-00Protocol codeD702BC00001Estimated enrolment880 patientsSponsorAstraZeneca AB

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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).