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Study Comparing Dostarlimab and Pembrolizumab with Chemotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

Fast replyRegistered 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 the non-squamous subtype. The study aims to compare the effectiveness of two different treatments. One treatment involves the drug Dostarlimab combined with chemotherapy, while the other uses Pembrolizumab with chemotherapy. Both treatments are administered through an intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to evaluate how well these treatments work in patients with metastatic non-squamous NSCLC, which means the cancer has spread to other parts of the body. Participants in the study will receive one of the two treatment combinations. The study will last for a period of up to 105 weeks, during which the participants will be monitored regularly to assess the response of their cancer to the treatment. The study will also look at the overall survival of participants and the time it takes for the cancer to progress or worsen.

Throughout the study, participants will undergo various health assessments, including blood tests and physical exams, to ensure their safety and to monitor any side effects. The study will also collect information on any adverse events, which are any unwanted effects that occur during the treatment period. This information will help researchers understand the safety and effectiveness 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, the participant will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment option.

  2. Step 2

    Treatment administration

    Participants will receive either dostarlimab or pembrolizumab in combination with chemotherapy. The specific chemotherapy drugs used are pemetrexed, carboplatin, or cisplatin.

    All medications will be administered through an intravenous infusion, which means they will be given directly into a vein through a needle or tube.

    The dosage and frequency of administration will be determined by the study protocol and the healthcare team overseeing the trial.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, participants will undergo regular monitoring to assess their response to the treatment. This includes physical examinations, blood tests, and imaging studies such as CT scans.

    The primary goal is to evaluate the overall response rate (ORR) to the treatment, which measures how well the cancer responds to the therapy.

  4. Step 4

    Safety evaluations

    Participants will be closely monitored for any side effects or adverse events. This includes tracking any new symptoms or changes in health status.

    Safety evaluations will continue for up to 90 days after the last dose of the study treatment to ensure participant well-being.

  5. Step 5

    Completion of the study

    The study is expected to conclude by October 29, 2025. Participants will be informed about the results and any further steps if necessary.

    Upon completion, participants may have follow-up visits to monitor their health and discuss any ongoing care needs.

Who can join the trial?

9 criteria

  • The participant must be at least 18 years old, able to understand the study procedures, and agree to participate by signing a written consent form.
  • The participant must have a confirmed diagnosis of **metastatic non-squamous non-small cell lung cancer (NSCLC)**, which means the cancer has spread beyond the lungs and is not of the squamous cell type. The cancer should not have specific genetic changes (mutations) for which targeted treatments are available.
  • The participant must have at least one measurable tumor, which means a tumor that can be measured in size using medical imaging. If the tumor was previously treated with radiation and has grown again, it can be considered measurable.
  • The participant must have a documented **PD-L1 status**, which is a test to see if the cancer cells have a certain protein that might affect treatment options.
  • The participant must have an **ECOG performance status** score of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The participant must have a life expectancy of at least 3 months.
  • The participant must have adequate organ function, which means their organs are working well enough to handle the treatment.
  • The participant must have recovered from any side effects of previous treatments to a mild level, except for hair loss, which can be more severe.
  • Participants must follow local guidelines for contraception to prevent pregnancy during the study and for a period after the study. Men must agree not to donate sperm and use condoms, while women must not be pregnant or breastfeeding and use effective birth control methods.

Who cannot join the trial?

3 criteria

  • Patients with a known **EGFR**, **ALK**, **ROS-1**, or **BRAF V600E mutation** cannot participate. These are specific changes in genes that can affect cancer growth and treatment.
  • Patients who have received any prior treatment for their **metastatic disease** are not eligible. Metastatic disease means the cancer has spread to other parts of the body.
  • Patients with other **genomic aberrations** for which a targeted therapy is available are excluded. Genomic aberrations are changes in the DNA that can be targeted with specific treatments.
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Investigated drugs

  • Dostarlimab

    is a medication used in this trial as a PD-1 inhibitor. It works by helping the immune system recognize and attack cancer cells. In this study, it is combined with chemotherapy to treat patients with metastatic non-squamous non-small cell lung cancer.

  • Pembrolizumab

    is another PD-1 inhibitor used in this trial. Like dostarlimab, it helps the immune system target and destroy cancer cells. It is also combined with chemotherapy in this study to treat patients with metastatic non-squamous non-small cell lung cancer.

  • Chemotherapy

    refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used in combination with either dostarlimab or pembrolizumab to enhance the treatment's effectiveness against metastatic non-squamous non-small cell lung cancer.

What is already known about the treatment

  • Dostarlimab

    Dostarlimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic non-squamous non-small cell lung cancer. It is a PD-1 inhibitor, which means it works by blocking the PD-1 protein on immune cells, helping the immune system to attack cancer cells more effectively. This medication is classified as an immune checkpoint inhibitor and is being evaluated for its potential to improve outcomes when combined with chemotherapy.

  • Pembrolizumab

    Pembrolizumab is also given intravenously and is widely used in medicine for various cancers, including non-small cell lung cancer. It functions as a PD-1 inhibitor, enhancing the immune system's ability to fight cancer by preventing the PD-1 protein from stopping immune responses. Pembrolizumab is classified as an immune checkpoint inhibitor and is being compared with dostarlimab in clinical trials to assess its efficacy in combination with chemotherapy for treating metastatic non-squamous non-small cell lung cancer.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically starts in the tissues of 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. The progression of the disease can vary, with some cases remaining localized while others may metastasize to distant organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505894-33-00Protocol code213403Estimated enrolment242 patientsSponsorGlaxosmithkline Research & Development Limited

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