Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Vudalimab or Pembrolizumab with Chemotherapy for Advanced Non-small Cell Lung Cancer Patients

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study explores treatments for an illness called advanced non-small cell lung cancer, a type of cancer affecting the lungs. This investigation focuses on how well two different medications work when combined with chemotherapy. The medications being tested are called vudalimab and pembrolizumab. Chemotherapy involves drugs administered to kill cancer cells and is a common treatment for cancer patients.

In this study, researchers aim to find out whether a combination of either vudalimab or pembrolizumab with chemotherapy is effective and safe for people with advanced non-small cell lung cancer. Vudalimab, listed with the code name XmAb20717, is being compared to pembrolizumab, a medication already used in cancer treatment. The study will use these drugs in combination with chemotherapy medicines like carboplatin and pemetrexed.

The main goal of the study is to determine which combination of drugs helps patients best in managing their cancer. Participants will receive the medications through an intravenous infusion, meaning the drugs will be delivered directly into their bloodstream. The study's results will provide insights into the most effective treatment for patients with advanced non-small cell lung cancer.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and current health status.

    Written informed consent is required to participate.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate health status and confirm the absence of certain genetic mutations.

    Tests include imaging and laboratory evaluations to establish baseline health metrics.

  3. Step 3

    Treatment assignment

    Participants are randomly assigned to one of two treatment groups: vudalimab with chemotherapy or pembrolizumab with chemotherapy.

    The assignment determines the specific medications and treatment schedule.

  4. Step 4

    Treatment administration

    Treatment involves intravenous infusions of the assigned medications.

    Medications include carboplatin, pemetrexed, pembrolizumab, and vudalimab, administered according to the study protocol.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess treatment effects and manage any side effects.

    Follow-up visits include physical exams, imaging, and laboratory tests to track progress.

  6. Step 6

    Completion of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate overall health and treatment outcomes.

    Participants may be asked to continue follow-up visits to monitor long-term effects.

Who can join the trial?

20 criteria

  • Must be able to provide written consent to participate in the study.
  • Must be 18 years of age or older.
  • Must have a confirmed diagnosis of advanced non-small cell lung cancer that cannot be surgically removed or has spread to other parts of the body.
  • Must not have certain genetic changes in the cancer, specifically in the EGFR, ALK, or ROS1 genes, which are known to drive cancer growth.
  • Must not have other genetic changes for which there are approved targeted treatments available.
  • Must have a specific test result showing a PD-L1 level, which is a protein on cancer cells, between less than 1% and 49%.
  • Must not have received previous treatment for advanced or metastatic non-small cell lung cancer, except for certain treatments completed at least 12 months before the cancer spread.
  • Must have measurable cancer according to specific medical guidelines, even if the cancer was previously treated with radiation.
  • Must provide a sample of the tumor that was preserved in a specific way for testing.
  • Must have a performance status score of 0 or 1, which indicates the ability to carry out daily activities.
  • Must have a life expectancy of at least 3 months.
  • Must have adequate organ function, as shown by specific blood test results, including:
    • Hemoglobin level of at least 9 g/dL without recent blood transfusions.
    • A certain level of white blood cells called neutrophils.
    • A certain level of platelets, which help with blood clotting.
    • Liver function tests within specific limits, depending on whether the cancer has spread to the liver.
    • Normal thyroid function, with or without medication.
    • Kidney function as measured by creatinine clearance of at least 45 mL/min.
    • Women who can become pregnant must agree to use effective birth control and not breastfeed during the study and for a specified time after the last dose of study drugs.
    • Men must agree to use effective birth control and not donate sperm during the study and for a specified time after the last dose of study drugs.
    • Must be able and willing to follow the study schedule and complete the study requirements.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer besides Advanced Non-small Cell Lung Cancer cannot participate.
  • Patients who have had a different cancer treatment recently may not be eligible.
  • Patients with certain medical conditions that could interfere with the study may be excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend required visits may not be eligible.
  • Patients with a history of severe allergic reactions to similar medications may be excluded.
  • Patients who are currently participating in another clinical trial may not be eligible.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Vudalimab

    is a medication being studied for its potential to treat advanced non-small cell lung cancer. It is being tested in combination with chemotherapy to see how safe and tolerable it is for patients. Researchers are also looking at how well it works compared to another treatment option.

  • Pembrolizumab

    is another medication used in this study. It is already known to help the immune system fight cancer cells. In this trial, it is combined with chemotherapy to see how effective it is as a first-line treatment for patients with advanced non-small cell lung cancer. The study aims to compare its effectiveness with the combination of vudalimab and chemotherapy.

What is already known about the treatment

  • Vudalimab

    Vudalimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced non-small cell lung cancer. It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indication for vudalimab is as a potential first-line treatment for this type of lung cancer. At the molecular level, vudalimab works by targeting specific proteins on cancer cells, helping the immune system to recognize and attack these cells more effectively. It is classified as an immunotherapy agent.

  • Pembrolizumab

    Pembrolizumab is given through an intravenous infusion and is an established medication in the treatment of various cancers, including advanced non-small cell lung cancer. It is widely recognized in medical literature and is used as a first-line treatment option. Pembrolizumab works by blocking a protein called PD-1 on immune cells, which enhances the body's immune response against cancer cells. It belongs to the class of drugs known as immune checkpoint inhibitors.

Investigated diseases

Advanced Non-small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its advanced stage, meaning it has spread beyond the lungs to other parts of the body. It is the most common type of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and form tumors, which can invade nearby tissues and organs. Over time, these cancerous cells can enter the bloodstream or lymphatic system, spreading to distant parts of the body, a process known as metastasis. Symptoms may include persistent cough, chest pain, and difficulty breathing, which can worsen as the disease advances.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509644-10-00Protocol codeXmAb717-06Estimated enrolment168 patientsSponsorXencor Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.