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Study of Immunotherapy Combinations with GSK4428859, Dostarlimab, and GSK6097608 for Patients with Advanced Non-Small Cell Lung Cancer

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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). The study is exploring new combinations of treatments for patients who have not received any prior treatment for their advanced or metastatic NSCLC. The treatments being tested include a combination of different immunotherapy drugs. These drugs are designed to help the body's immune system fight cancer more effectively. The medications involved in this study include a drug with the code name GSK4428859, Jemperli (also known as Dostarlimab), a drug with the code name GSK6097608, and Keytruda (also known as Pembrolizumab).

The purpose of the study is to evaluate how well these new immunotherapy combinations work compared to Pembrolizumab alone in patients with a specific type of NSCLC that shows high levels of a protein called PD-L1. This protein can affect how the immune system responds to cancer. The study will involve participants receiving these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period of time to observe the effects of the treatments on their cancer.

Participants in the study will be monitored closely by healthcare professionals to ensure their safety and to gather information about how the treatments are working. The study aims to provide valuable insights into the effectiveness of these new treatment combinations for NSCLC, potentially leading to better treatment options for patients 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, the participant will be required to provide a tumor tissue sample. This sample must be obtained at the time of or after the initial diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC).

    The participant must have a tumor with high levels of a protein called PD-L1, which is determined by a specific test.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm the diagnosis of NSCLC and to ensure the participant meets all eligibility criteria. This includes having measurable disease and adequate organ function.

    The participant's performance status will be evaluated using the Eastern Cooperative Oncology Group (ECOG) scale, which measures the ability to perform daily activities.

  3. Step 3

    Treatment phase

    The participant will receive treatment with one of the following medications: JEMPERLI (dostarlimab) or KEYTRUDA (pembrolizumab). Both are solutions for infusion administered intravenously.

    The specific dosage and frequency of administration will be determined by the study protocol and the participant's response to treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the participant will undergo regular monitoring to assess the response to treatment. This includes imaging tests and other assessments as determined by the study protocol.

    The participant will be monitored for any side effects or adverse events related to the treatment. Adjustments to the treatment plan may be made based on these observations.

  5. Step 5

    Completion of study

    The study is estimated to conclude by May 4, 2028. Upon completion, the participant's overall response to the treatment will be evaluated.

    The participant's health status will continue to be monitored for a specified period after the study to ensure long-term safety and effectiveness of the treatment.

Who can join the trial?

10 criteria

  • The patient must be able to give signed informed consent, which means they understand the study and agree to follow its rules.
  • If the patient is a woman who can have children, she must agree to use effective birth control and not be pregnant or breastfeeding. She also agrees not to donate eggs during the study.
  • The patient must be at least 18 years old or the legal age of consent in their area.
  • The patient must have a confirmed diagnosis of **non-small cell lung cancer (NSCLC)** that is locally advanced and cannot be removed by surgery, or has spread to other parts of the body.
  • The patient must not have received previous treatment for their advanced or spread NSCLC.
  • The patient must provide a sample of their tumor tissue taken at the time of or after their diagnosis.
  • The patient's tumor must have a high level of **PD-L1**, a protein that can affect the immune system's response to cancer.
  • The patient must have a disease that can be measured using a specific method called **RECIST 1.1**, which helps doctors track the size of tumors.
  • The patient must have an **ECOG PS** (Eastern Cooperative Oncology Group Performance Status) of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than Non-Small Cell Lung Cancer.
  • Patients whose cancer does not have a high level of PD-L1. PD-L1 is a protein that can affect how the immune system fights cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who have other medical conditions or factors that the study team believes would make it unsafe or inappropriate for them to participate.
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Investigated drugs

  • Pembrolizumab

    is a type of immunotherapy used in this trial. It works by helping the immune system recognize and attack cancer cells. It is specifically used for treating non-small cell lung cancer that has a high level of a protein called PD-L1.

  • Novel Immunotherapy Combinations

    are new treatments being tested in this trial. These combinations aim to enhance the body's immune response against cancer cells. The goal is to find more effective ways to treat non-small cell lung cancer by using these new combinations alongside or instead of existing treatments like pembrolizumab.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given every three weeks. It is currently well-established in medical literature as an effective treatment for certain types of cancer, including non-small cell lung cancer (NSCLC). The main therapeutic indication for pembrolizumab is in treating cancers that express high levels of PD-L1, a protein that helps tumors evade the immune system. At the molecular level, pembrolizumab works by blocking the interaction between PD-1 receptors on immune cells and PD-L1 on cancer cells, thereby enhancing the body's immune response against the tumor. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that helps the immune system recognize and attack cancer cells.

Investigated diseases

Lung Cancer, Non-Small Cell – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and squamous cell carcinoma. It is the most common form of lung cancer, accounting for about 85% of cases. The disease typically begins in the cells lining the lungs and can spread to other parts of the body. Non-small cell lung cancer often grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505057-40-00Protocol code213824Estimated enrolment340 patientsSponsorGlaxosmithkline Research & Development Limited

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