A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
This research study, called ARTEMIDE-Lung02, is for people with a type of advanced lung cancer called squamous non-small cell lung cancer that has spread to other parts of the body. Doctors are trying to find out if a new drug called rilvegostomig, when given with standard chemotherapy, works better or similarly to another existing immune therapy drug, pembrolizumab, also given with chemotherapy. Both combinations are being tested as the first treatment patients receive for their advanced cancer. The study will look at how well these treatments work to control the cancer and if they are safe. It's a large, worldwide study, and participants' cancer cells must show a certain marker called PD-L1.
At a glance
What is this study about?
This study, called ARTEMIDE-Lung02, is designed for people who have a specific type of lung cancer called squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. This is a common and serious form of lung cancer. When cancer has spread, it's called 'metastatic', and the goal of treatment is to control the disease, improve quality of life, and help people live longer.
In this study, researchers are comparing two different treatment approaches. One approach involves a new medicine called rilvegostomig, which works with your body's immune system, given alongside standard chemotherapy. The other approach uses an existing immune therapy drug called pembrolizumab, also given with standard chemotherapy. Both of these are given as the first treatment for this type of advanced lung cancer. The doctors want to find out if the new drug combination is more effective or just as effective and safe as the established treatment.
To make sure the treatments are compared fairly, participants will be randomly assigned to receive one of the two combinations. Neither you nor your doctor will know which treatment you are getting (this is called 'double-blind'). This helps ensure the results are reliable. The study will carefully monitor how well the treatments shrink the cancer and how you feel, looking for any side effects. The aim is to find better first-line treatment options for patients with this challenging form of lung cancer.
Key takeaways
- This study is for people with advanced squamous non-small cell lung cancer that has spread.
- It's comparing a new drug plus chemotherapy against an existing immune therapy plus chemotherapy.
- The goal is to find better first-line treatments and improve patient outcomes.
- Your cancer must show a specific marker called PD-L1.
- You will be randomly assigned to one of two treatment groups, and neither you nor your doctor will know which one.
- Participation involves regular hospital visits for treatment, tests, and monitoring.
Who may be eligible?
To join this study, you must have a specific type of advanced lung cancer called squamous non-small cell lung cancer that has spread. Your doctors will need to confirm this with a tissue sample. It's important that your cancer hasn't been treated before with systemic therapy (like chemotherapy or immunotherapy) for the advanced stage, and you shouldn't have had certain other immune-targeting treatments in the past. Your cancer cells also need to show a marker called PD-L1, which will be checked from a tissue sample.
You should generally be in good health for an advanced cancer patient, with your body organs, like your kidneys and liver, working well. Your doctors will take measurements of your cancer to track how it responds to treatment. There are also specific rules about other medical conditions; for example, if you've had brain metastases (cancer spread to the brain), they must be stable and not causing symptoms or requiring certain medications.
People with other types of cancer recently, or those with active autoimmune conditions that require strong medicines, would usually not be able to join. Also, if you have certain genetic changes in your cancer that have approved targeted treatments, this study might not be suitable 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 confirmed advanced squamous non-small cell lung cancer that has spread?
- Have you not received any prior treatment for your advanced lung cancer?
- Do your cancer cells show the PD-L1 marker?
- Are you generally feeling well despite your cancer, with good organ function?
- Do you have no active serious autoimmune conditions or other recent cancers?
What does participation involve?
If you join this study, you will receive either rilvegostomig plus chemotherapy or pembrolizumab plus chemotherapy. The chemotherapy drugs used are carboplatin and either paclitaxel or nab-paclitaxel. You will typically receive treatments as infusions, usually in cycles over several weeks. You'll have regular hospital visits for these treatments, as well as for blood tests, physical exams, and scans (like CT or MRI) to check how the cancer is responding and to monitor for any side effects. The exact number and frequency of visits will depend on your treatment cycle and how you are responding. You will also have follow-up appointments after your treatment ends. The total duration of your participation could vary, continuing as long as the treatment is beneficial and you are tolerating it well, followed by a follow-up period to monitor your health.
Potential risks and benefits
Locations (301)
- Research SiteVerified postcodeTucson, United States· Recruiting
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- Research SiteVerified postcodeBay Pines, United States· Recruiting
Common questions
What is 'squamous non-small cell lung cancer'?
It's a common type of lung cancer that starts in the flat cells lining the airways of the lungs. 'Metastatic' means it has spread to other parts of the body.
What does 'first-line treatment' mean?
This means the treatment you receive first for your advanced cancer, before trying other medications if needed.
What is PD-L1?
PD-L1 is a protein found on some cancer cells. If your cancer cells have PD-L1, it can help doctors decide if certain immune therapies might work for you.
What is the difference between rilvegostomig and pembrolizumab?
Both are immune therapies that help your body fight cancer. Rilvegostomig is a newer drug being tested, while pembrolizumab is an established treatment. This study compares them.
Will I know which treatment I'm receiving?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know which specific study drug you are getting. This helps ensure fair and accurate results.
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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