Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined with Domvanalimab (AB154) Compared to Pembrolizumab in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This important trial is comparing a new combination of treatments for a type of lung cancer called non-small cell lung cancer, which has spread or is advanced. Researchers want to see if combining two new drugs, zimberelimab and domvanalimab, works better than the current standard treatment, pembrolizumab (also known as Keytruda). They are particularly looking at patients whose cancer has high levels of a specific protein called PD-L1. The main goal is to find out if the new combination helps people live longer. They will also look at how long people live without their cancer growing, how many people respond to the treatment, and any side effects people might experience.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Arcus Biosciences Inc.

Enrolment target

106

Start

22 Nov 2023

Squamous Non-small cell Lung Cancer Non-Small Cell Lung Cancer Non squamous Non Small Cell Lung Cancer Lung Cancer

What is this study about?

This study is about finding better ways to treat a specific type of lung cancer called non-small cell lung cancer. This is the most common type of lung cancer. The study is for people whose cancer has either spread to other parts of their body (metastatic) or is advanced and can't be removed by surgery (locally advanced). Doctors are particularly interested in patients whose cancer cells show high levels of a protein called PD-L1 on their surface, as this information can help guide treatment.

The main idea behind this trial is to see if a new combination of two medicines, called zimberelimab and domvanalimab, is more effective than a well-known treatment called pembrolizumab (which you might know as Keytruda). Pembrolizumab is a type of immunotherapy that helps your own immune system fight cancer. The researchers want to know if giving these two new drugs together can help people live longer with their condition.

In simple terms, this trial is a direct comparison between a new approach and an existing standard treatment. By doing this comparison, doctors hope to discover if the new combination could become a better first-choice treatment for this specific group of lung cancer patients, potentially improving their outcomes and quality of life.

Key takeaways

This study is for advanced non-small cell lung cancer.
It compares a new drug combination to a standard treatment.
The main aim is to see if the new combination helps people live longer.
Only patients whose cancer has high levels of PD-L1 can join.
Participants will receive treatment via IV drip and have regular check-ups.

Who may be eligible?

To be able to join this study, generally, you must be 18 years old or older. The study is open to both men and women.

Specifically, you would need to have non-small cell lung cancer that is advanced (meaning it has spread or is very difficult to treat locally) and has not been treated before for this advanced stage. Your cancer cells would also need to show high levels of a particular protein called PD-L1.

The doctors running the study will check if your overall health is good enough to take part and if you meet other specific medical requirements. They will explain all these details clearly if you are interested.

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.

Are you 18 years old or older?
Do you have non-small cell lung cancer that is locally advanced or has spread?
Has your advanced lung cancer not been treated before?
Do your cancer cells show high levels of the PD-L1 protein?
Are you generally in good health other than your cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new combination of drugs (zimberelimab and domvanalimab) or the standard treatment (pembrolizumab) through a drip (infusion) into your vein. You would have regular visits to the clinic to receive your medicines and for check-ups. These check-ups will involve things like blood tests, measuring your vital signs (like blood pressure and heart rate), and having scans to see how your cancer is responding.

The research team will also ask you questions about how you are feeling and any symptoms you might have. This helps them understand how the treatment is affecting your daily life. The total length of your participation will depend on how you respond to the treatment, but there will also be a follow-up period to monitor your health even after treatment stops.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to new treatments before they are widely available, which may be more effective than current options for your condition. However, there are also potential risks involved, as with any medical treatment. The new drugs or the standard treatment could cause side effects, which might be mild or more serious. The research team will monitor you very closely for any side effects and will explain all the known risks before you decide to join. It is important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Ireland
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Unverified
Spain
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Unverified
France
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Unverified
Greece

Common questions

What type of lung cancer is this study for?

This study is for a common type of lung cancer called non-small cell lung cancer, specifically if it's advanced or has spread, and shows high levels of the PD-L1 protein.

What are the treatments being tested?

Two new drugs, zimberelimab and domvanalimab, given together, are being compared to a standard treatment called pembrolizumab (Keytruda).

What is the main goal of the study?

The main goal is to see if the new combination of drugs helps people live longer than the standard treatment.

How will they know if the treatment is working?

Doctors will use scans and other tests to see if the cancer shrinks or stops growing, and they will track how long people live.

Who can take part in this study?

Generally, adults aged 18 and over with previously untreated, advanced non-small cell lung cancer with high PD-L1 levels might be eligible.