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RecruitingPHASE1, PHASE2INTERVENTIONAL

Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Organoid (PDOs)s and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

This research focuses on people with non-small cell lung cancer that has come back or spread. The main goal is to find better ways to predict which treatments will be most effective for each person. Researchers are using three innovative tools: very tiny particles from the body (called Extracellular Vesicles), mini-tumours grown in the lab from a patient's own cancer cells (Patient-derived Organoids), and special body scans (PET scans) that look at certain markers on cancer cells. By studying these tools, the team hopes to understand how changes in the cancer's biology, especially a marker called PDL1, can tell us whether a standard treatment like immunotherapy will work well. This could lead to more personalised and effective care for people with this type of lung cancer.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
GlaxoSmithKline
Enrolment target
40
Start
30 Dec 2025
Estimated completion
10 Oct 2029

What is this study about?

This study is designed for individuals in the UK who have been diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC). This is the most common kind of lung cancer. Specifically, it's for people whose cancer was first treated but has since returned or spread to other parts of the body.

The main aim of this research is to improve how doctors predict whether a particular treatment will work well for you. Imagine if doctors could know beforehand which medicine would be most effective, saving you time and reducing side effects from treatments that might not work. This study is exploring new ways to do just that. They are looking at three advanced methods: first, tiny bubbles released by cells, called Extracellular Vesicles (EVs), which can be found in blood. Second, they are growing mini-tumours in the lab from a small sample of your own cancer cells, called Patient-derived Organoids (PDOs). These PDOs act like a 'mini-me' of your tumour, allowing researchers to test treatments outside your body. Third, they are using special body scans (PET scans) that can light up specific markers on cancer cells.

By combining information from these three tools, especially focusing on a marker called PDL1, researchers hope to get a clearer picture of how a person's cancer might respond to standard treatments given for advanced lung cancer. This knowledge could help doctors make more informed decisions about treatment plans, potentially leading to more effective and personalised care for future patients.

Key takeaways

  • A UK study for recurrent or advanced non-small cell lung cancer.
  • Aims to predict which current treatments will work best for patients.
  • Uses blood tests (EVs), lab-grown mini-tumours (PDOs), and special scans (PET).
  • Focuses on a cancer marker called PDL1 to guide treatment.
  • Could lead to more personalised and effective care in the future.
  • Participants would receive standard, approved lung cancer treatments.

Who may be eligible?

To be considered for this study, you must have non-small cell lung cancer that was treated in the past, but has now returned or spread. When you were first diagnosed, your cancer should have been at an early stage (Stage 1 to 3) and you would have had surgery to remove it, possibly along with other treatments.

Doctors will also need to know the 'PDL1' status of your cancer before you start. You must have at least one measurable area of cancer that doctors can track with scans like CT or MRI. Your medical team must also believe that the standard treatments offered in this study are suitable for you. Finally, a small sample of your cancer tissue will need to be available so that a 'mini-tumour' model can be grown in the lab.

If you have HIV, you can still participate, but there are specific requirements related to managing your HIV infection, including having a very low level of the virus in your blood and a healthy immune cell count.

Quick self-check
  • Have I been diagnosed with non-small cell lung cancer that has come back or spread?
  • Was my lung cancer initially treated with surgery at an early stage (Stage 1-3)?
  • Will my doctor be able to check my cancer's PDL1 status?
  • Do I have at least one area of cancer that can be measured on a scan?
  • Am I considered suitable for standard advanced lung cancer treatments?
  • Is a small sample of my cancer tissue available for lab testing?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This section has not been provided in the brief information. Please consult with your hospital care team regarding the specific details of participation, including number of visits, assessments, medication, follow-up, and total duration.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to new treatment approaches and close monitoring by a medical team. However, there may also be risks, including potential side effects from treatments or procedures, and the possibility that the treatment may not work for you. You will be given a full explanation of all known risks and benefits before deciding to join. Remember, you have the right to withdraw from the study at any time without affecting your standard medical care.

Locations (1)

  • GSK Investigational Site
    London, United Kingdom· Recruiting

Common questions

What is PDL1 and why is it important?

PDL1 is like a signal on cancer cells that can help them hide from your body's immune system. Knowing its status can help doctors decide if certain treatments, like immunotherapy, might work well.

What are Extracellular Vesicles (EVs)?

EVs are tiny packages released by cells, including cancer cells. They carry important information and can be found in your blood, potentially providing clues about your cancer without needing another biopsy.

What are Patient-derived Organoids (PDOs)?

PDOs are like tiny, lab-grown versions of your own tumour. They are created from a sample of your cancer and can be used to test different treatments outside your body to see what might work best for you.

What is a PET scan?

A PET scan is a special type of body scan that can show how active your cells are. In this study, it's used to look for specific markers on cancer cells to understand them better.

Will I receive new, experimental treatments?

This study investigates tools to predict response to standard treatments for advanced lung cancer (Pembrolizumab, Dostarlimab, Pemetrexed + Carboplatin/Cisplatin). You would be receiving treatments that are already approved, but the way researchers study your cancer may help future patients.

How to find out more

US GSK Clinical Trials Call Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of Programmed Death Ligand 1 (PDL1) Response to T…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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