A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
This research study, called ARTEMIDE-Lung03, is for people with advanced non-small cell lung cancer that has spread and has specific markers (PD-L1 positive). It's a Phase 3 study, meaning it's in the later stages of testing new treatments. The main goal is to see how well rilvegostomig, a new drug, works when combined with chemotherapy, compared to pembrolizumab (a common immunotherapy drug) also with chemotherapy. Researchers want to find out if rilvegostomig helps patients live longer or keeps their cancer under control for longer, and if it has fewer side effects. Both men and women aged 18 and over can potentially take part.
At a glance
What is this study about?
Imagine your body's immune system as an army designed to fight off infections and diseases, including cancer. Sometimes, cancer cells are clever and find ways to hide from this army. Treatments like immunotherapy try to 'unhide' cancer cells so your immune system can attack them more effectively.
This study is looking at a type of lung cancer called non-squamous non-small cell lung cancer that has spread to other parts of the body (this is called 'metastatic'). For people with this type of cancer, doctors often check for a marker called PD-L1 on the cancer cells. If this marker is present, certain immunotherapies can be very helpful. This study is specifically for people whose cancer cells show this PD-L1 marker.
The study aims to compare two different treatment approaches. One approach uses a drug called rilvegostomig, which is an experimental drug, combined with standard chemotherapy. The other approach uses a well-known immunotherapy drug called pembrolizumab, also with standard chemotherapy. By comparing these two combinations, doctors hope to find out if rilvegostomig offers a better or safer option for patients with this specific type of lung cancer. It's a large, important study (a 'Phase 3' study), meaning it's a crucial step in potentially bringing new treatments to patients.
Key takeaways
- Targets advanced non-small cell lung cancer (non-squamous type) that has spread.
- Compares two immunotherapy approaches with chemotherapy.
- Aims to find out if rilvegostomig is better or safer than pembrolizumab.
- Patients are randomly assigned to a treatment group, and neither they nor their doctor will know which one ('double-blind').
- Requires regular hospital visits, blood tests, and scans.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you would need to have non-small cell lung cancer that has spread and is not curable with current treatments. It must also be a specific type called 'non-squamous.' Your doctors would need to check your cancer cells for certain genetic changes; if you have specific EGFR, ALK, or ROS1 gene changes, or other similar changes for which there are approved treatments, this study might not be right for you. Your cancer would also need to show a particular marker called PD-L1.
The study is for adults aged 18 and over. You would also need to be generally well enough to take part and have your organs (like your liver and kidneys) working properly. Doctors would need to be able to measure your cancer on scans to see if the treatment is working.
You would not be able to join if your cancer has small cell features or if you have uncontrollable brain tumours. If you've already had certain targeted cancer treatments or immunotherapy affecting your immune system, you would also not be eligible. If you had treatment for early-stage lung cancer, you might still qualify if your cancer returned more than a year after that treatment.
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 I have advanced non-small cell lung cancer that has spread?
- Is my cancer the 'non-squamous' type?
- Does my cancer have the PD-L1 marker?
- Have I not had certain gene changes (like EGFR, ALK, ROS1) that have other approved treatments?
- Am I generally well enough to take part in a study?
- Have I not had previous immunotherapy or targeted treatments that affect my immune system for advanced lung cancer?
What does participation involve?
If you join this study, you will be randomly assigned by chance to one of two treatment groups, like flipping a coin. Neither you nor your study doctor will know which treatment you are receiving (this is called 'double-blind'). You will receive either rilvegostomig or pembrolizumab, along with chemotherapy drugs (carboplatin or cisplatin, and pemetrexed). These treatments are given as drips, usually in a hospital or clinic.
You will have regular hospital visits for your treatments, blood tests, physical exams, and scans (like CT or MRI scans) to monitor your health and how the treatment is affecting your cancer. These assessments will help doctors track your progress and any side effects. The exact number of visits and the full duration of your participation will depend on how you respond to the treatment and the study plan, but you will be monitored closely throughout. Follow-up appointments will continue even after treatment stops.
Potential risks and benefits
Locations (283)
- Research SiteVerified postcodeMobile, United States· Recruiting
- Research SiteVerified postcodeChandler, United States· Withdrawn
- Research SiteVerified postcodePhoenix, United States· Recruiting
- Research SiteVerified postcodeAnaheim, United States· Recruiting
- Research SiteVerified postcodeBeverly Hills, United States· Recruiting
- Research SiteVerified postcodeLoma Linda, United States· Not yet recruiting
- Research SiteVerified postcodeRedlands, United States· Recruiting
- Research SiteVerified postcodeSan Diego, United States· Recruiting
- Research SiteVerified postcodeSan Francisco, United States· Recruiting
- Research SiteVerified postcodeSanta Rosa, United States· Recruiting
- Research SiteVerified postcodeWalnut Creek, United States· Recruiting
- Research SiteVerified postcodeLone Tree, United States· Recruiting
Common questions
What type of lung cancer is this study for?
It's for people with advanced non-small cell lung cancer that has spread, specifically the 'non-squamous' type, and has a marker called PD-L1.
What are the treatments being tested?
The study compares a new drug called rilvegostomig with an existing drug called pembrolizumab, both given alongside standard chemotherapy.
Will I know which treatment I'm getting?
No, you won't know if you're getting rilvegostomig or pembrolizumab because this is a 'double-blind' study.
What does a 'Phase 3' study mean?
Phase 3 means it's a large study comparing a new treatment to standard care to see if it's better or safer before it can be widely approved.
How long will I be in the study?
Your participation will continue as long as the treatment is helping you and you are tolerating it, or until the end of the study. You'll also have follow-up appointments after treatment.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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