RecruitingPHASE3INTERVENTIONAL

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

This research study, called ARTEMIDE-Lung04, is looking into a new medication called rilvegostomig to treat a type of advanced lung cancer known as non-small cell lung cancer (NSCLC). This new drug is being compared to a medication already used, pembrolizumab. The study is specifically for people whose lung cancer has spread (metastatic) and has high levels of a protein marker called PD-L1. Researchers want to find out if rilvegostomig is as effective or more effective than pembrolizumab in shrinking tumours and improving how long people live, while also checking for any side effects. This is a large, worldwide study, and participants will be randomly assigned to receive one of the two treatments.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

830

Start

10 Apr 2025

Estimated completion

02 Dec 2030

Carcinoma, Non-Small Cell Lung

What is this study about?

This clinical trial is designed to investigate new possible treatments for a specific type of lung cancer known as non-small cell lung cancer (NSCLC). This is the most common form of lung cancer. In this particular study, the focus is on patients whose cancer has spread to other parts of the body (this is called metastatic cancer) and who haven't started treatment for it yet. Researchers are especially interested in patients whose cancer cells show high levels of a particular protein marker called PD-L1. This marker helps doctors understand how likely certain treatments, like those in this study, might work.

The main goal of the study is to compare a new experimental drug, rilvegostomig, with an existing, commonly used treatment, pembrolizumab. Both of these drugs are types of immunotherapy, which work by helping your body's own immune system fight off cancer cells. The trial wants to see if rilvegostomig can stop the cancer from growing, shrink tumours, and help people live longer, just as effectively or even better than pembrolizumab. Safety is also a very important part of the study, so researchers will be carefully monitoring any side effects.

By comparing these two treatments, doctors hope to gain a clearer understanding of how rilvegostomig works and if it could offer a new, effective option for people with this specific type of advanced lung cancer in the future. This kind of research is vital for improving treatments and patient outcomes.

Key takeaways

Tests a new drug (rilvegostomig) against a standard drug (pembrolizumab) for lung cancer.
Specifically for advanced non-small cell lung cancer with high PD-L1 levels.
Aims to see which treatment is safer and more effective as first treatment.
Participants will be randomly assigned to one of the two treatments.
Involves regular clinic visits, blood tests, and scans to monitor health and treatment response.

Who may be eligible?

To join this study, you must have non-small cell lung cancer that has spread to other parts of your body and it must be your first treatment for the advanced cancer. Your cancer cells need to show high levels of a specific protein marker called PD-L1. Also, doctors will check that your cancer doesn't have certain genetic changes (like EGFR, ALK, or ROS1 mutations) that are usually treated with different medicines.

You should also be generally well enough to take part, meaning you're able to carry out most of your daily activities without much difficulty. You'll need to be at least 18 years old and expected to live for at least 12 weeks. You’ll also need to provide a sample of your tumour for testing and have at least one measurable tumour that can be tracked with scans.

There are also some reasons why you might not be able to join. For example, if you have other serious uncontrolled health conditions, a history of organ transplant, long-term autoimmune conditions requiring strong medication, or certain other types of cancer. The study team will review all your medical information carefully to make sure the study is right for you.

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.

Do you have non-small cell lung cancer that has spread?
Is this your first treatment for your advanced lung cancer?
Does your cancer have high levels of the PD-L1 marker?
Are you at least 18 years old?
Are you generally well enough to take part in daily activities?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either the new drug, rilvegostomig, or the standard drug, pembrolizumab. This means neither you nor your doctor will get to choose which treatment you receive, and for some time, you won't know which one it is (this is called 'double-blind'). Both drugs will be given through a drip into your vein.

Throughout the study, you'll have regular visits to the clinic for medical check-ups, blood tests, and scans (like CT or MRI) to see how your body is responding to the treatment and to monitor for any side effects. You'll also need to provide tumor samples. The study will continue for as long as the treatment is helping you and you are tolerating it well. After you stop treatment, there will be follow-up appointments to monitor your health over time. The total duration of your involvement could vary depending on your response to treatment.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new experimental treatment that might be effective for your condition and close medical monitoring. However, there are also potential risks, as new drugs can have unexpected side effects, and even standard treatments have known side effects. There's no guarantee that the treatment will work for you, and there's a chance you might experience side effects that can range from mild to severe. The study team will discuss all known risks with you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (296)

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

Research Site
Verified postcode
La Mesa, United States· Not yet recruiting
Research Site
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Los Alamitos, United States· Not yet recruiting
Research Site
Verified postcode
Farmington, United States· Recruiting
Research Site
Verified postcode
Newark, United States· Recruiting
Research Site
Verified postcode
Bay Pines, United States· Recruiting
Research Site
Verified postcode
Clearwater, United States· Recruiting
Research Site
Verified postcode
St. Petersburg, United States· Recruiting
Research Site
Verified postcode
Marietta, United States· Recruiting
Research Site
Verified postcode
Chicago, United States· Recruiting
Research Site
Verified postcode
Decatur, United States· Recruiting
Research Site
Verified postcode
Des Moines, United States· Recruiting
Research Site
Verified postcode
Waterloo, United States· Not yet recruiting

Common questions

What is PD-L1 and why is it important?

PD-L1 is a protein found on some cancer cells. High levels of PD-L1 can indicate that certain immunotherapies, like the ones in this study, might be more effective in treating your cancer.

What does 'first-line treatment' mean?

First-line treatment means that this study is for people who haven't received any previous treatment for their advanced (metastatic) non-small cell lung cancer.

Will I know which drug I'm receiving?

In this particular study, it's 'double-blind' which means you and your study doctor will not know if you are receiving rilvegostomig or pembrolizumab during the main part of the study.

What happens if the drug doesn't work for me?

If your cancer gets worse or you experience intolerable side effects, the study drug will be stopped, and your doctors will discuss other treatment options with you.

What kind of scans will I have?

You'll have regular scans, such as CT or MRI, to check on your cancer and see how it's responding to the treatment.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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