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Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer

This research is looking at non-small cell lung cancer that has spread or can't be removed by surgery. It's a 'Phase 3' study, meaning it's a large trial to confirm if a new treatment is effective and safe. We're comparing a new combination of two drugs, ociperlimab and tislelizumab, to an already approved drug called pembrolizumab (also known as KEYTRUDA). Participants will be randomly assigned to receive either the new combination or pembrolizumab. The main goal is to find out if the new treatment helps people live longer and if it improves their quality of life compared to the standard treatment. We also want to understand any side effects.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Beigene Ltd.
Enrolment target
135
Start
08 Mar 2024

What is this study about?

This study is for people in the UK who have been diagnosed with a type of lung cancer called non-small cell lung cancer. This cancer is considered 'advanced' if it has spread beyond the original site, meaning it might be in other parts of the body (metastatic), or if it's grown too much to be removed by surgery (locally advanced, unresectable). For this study, doctors have also found a specific marker called 'PD-L1' on the cancer cells, which helps them decide if this type of treatment is suitable.

The trial is a 'Phase 3' study, which is the final stage of testing a new treatment before it can be approved for wider use. It's designed to be a very fair comparison: some people will receive a new combination of medications (ociperlimab and tislelizumab), while others will receive a treatment that's currently used (pembrolizumab, also known as KEYTRUDA). To make sure the results are unbiased, neither you nor your doctors will know which treatment you are getting – this is called a 'double-blind' study. Everyone will also receive a saline solution, which is just sterile salt water, as part of their treatment administration.

The main thing the researchers want to find out is whether the new combination helps people live longer than those on the standard treatment. They will also be looking closely at how long it takes for the cancer to grow or spread, if the tumours shrink, and for how long. Another important aspect is how the treatments affect your daily life and well-being, often called 'quality of life'. They will also carefully record any side effects you experience to fully understand the safety of these treatments.

Key takeaways

  • It's a study for advanced non-small cell lung cancer.
  • Compares a new drug combination to a standard treatment.
  • Aims to see if the new treatment helps people live longer and better.
  • Participants are randomly assigned to a treatment group.
  • Neither you nor your doctor will know which treatment you receive.
  • Your quality of life and side effects will be carefully monitored.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or over. This study is open to both men and women.

You would need to have been diagnosed with advanced non-small cell lung cancer that either can't be removed by surgery or has spread to other parts of your body. Your doctors would also need to have identified a specific feature called 'PD-L1' on your cancer cells.

Your medical team will check other details of your health to make sure this study is right for you and safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with non-small cell lung cancer that is advanced or has spread?
  3. Has your doctor confirmed your cancer cells have a 'PD-L1' marker?
  4. Are you able to attend regular hospital visits for treatment and check-ups?
Answer every question to see your result.

What does participation involve?

If you decide to participate, you will be randomly assigned to one of two groups. One group will receive the new combination of ociperlimab and tislelizumab, and the other group will receive pembrolizumab. Both treatments are given through a drip (infusion) into a vein. You will also receive a saline solution as part of the process. The study will involve regular visits to the hospital for your treatments, blood tests, scans to check your cancer, and discussions with the study team. You will also be asked to fill in questionnaires about your health and how you are feeling, which helps the researchers understand your quality of life. The total duration of your participation will depend on how you respond to the treatment and how long the study continues, but there will be ongoing follow-up to monitor your health. Your study team will explain the full schedule of visits and tests.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that could be more effective than current options for your lung cancer. However, there's no guarantee that the treatment will work for you, and it might not improve your condition. Like all medications, the study drugs can have side effects, which could range from mild to serious. The research team will monitor you closely for any side effects and will explain these to you before you agree to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Poland
  • Unverified
    France
  • Unverified
    Spain
  • Unverified
    Italy
  • Unverified
    Germany
  • Unverified
    Netherlands

Common questions

What kind of cancer is this study for?

This study is for a type of lung cancer called non-small cell lung cancer that is advanced (has spread or can't be removed by surgery).

What are the treatments being tested?

We are testing a new combination of drugs, ociperlimab and tislelizumab, against an existing treatment called pembrolizumab (KEYTRUDA).

Will I know which treatment I'm getting?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving until the study is over.

What is the main goal of the study?

The main goal is to see if the new drug combination helps people live longer and improves their quality of life compared to the standard treatment.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, and it won't affect your future medical care.

How to find out more

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

Discussion

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