Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
This research study is for people with a type of advanced non-small cell lung cancer that hasn't been treated before. Doctors are testing two new drug combinations, Dato-DXd with rilvegostomig, or rilvegostomig on its own. They want to see how these new treatments compare to a standard treatment called pembrolizumab. The aim is to find out if the new drugs are more effective at shrinking the cancer and if they are safe to use as a first treatment. This study focuses on lung cancers with high levels of a protein called PD-L1 and without certain genetic changes that other treatments target. It's a 'Phase 3' study, meaning it's a larger trial to confirm earlier promising results.
At a glance
What is this study about?
This research study is looking for better ways to treat a specific type of advanced lung cancer, called non-small cell lung cancer (NSCLC). Specifically, it's for people whose cancer has spread or is advanced, and who haven't had treatment for it yet. The study focuses on cancers that don't have certain genetic changes that are treatable with other medicines, and where the cancer cells show high levels of a specific marker called PD-L1.
The main goal of the study is to compare new treatment approaches with a standard treatment often used for this kind of cancer. The new treatments involve a drug called Dato-DXd given together with another drug called rilvegostomig, or rilvegostomig on its own. These are being compared to the standard treatment, which is a drug called pembrolizumab. Researchers want to find out if the new drug combinations are more effective at treating the cancer and if they are safe for patients.
Taking part in a study like this helps doctors learn more about new medicines. This could lead to more effective treatments for people with lung cancer in the future. All participants will receive a treatment, and their health will be carefully monitored throughout the study.
Key takeaways
- This study is for a specific type of advanced lung cancer (non-small cell).
- It tests new drug combinations against a standard treatment as a first-line option.
- Only people with high PD-L1 levels and without certain genetic changes are eligible.
- All participants receive active treatment, and their health is closely monitored.
- Participation involves regular hospital visits for treatments and check-ups.
- It's a chance to access potentially new treatments and contribute to medical science.
Who may be eligible?
To join this study, you would need to have a specific type of advanced non-small cell lung cancer that has been confirmed by tests. This means your cancer would be considered advanced or have spread, and surgery or strong radiation treatment isn't an option. Your cancer must not have certain genetic changes that other specific drugs target, and it needs to show a high level of a marker called PD-L1 (meaning 50% or more of your cancer cells have it).
You must be at least 18 years old and in generally good health, typically able to do most everyday activities without much trouble. Doctors will also check your organ function and ensure you have suitable cancer sites that can be measured during the study.
There are also reasons why you might not be able to join. For example, if you've already had systemic treatment for your advanced lung cancer, or if your lung cancer is a different type (like small cell lung cancer or squamous cell dominant). People with certain other medical conditions, like some autoimmune diseases, or serious lung problems, might also not be suitable. Your doctor will carefully review all your medical information to see if this 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 I have advanced non-small cell lung cancer?
- Has my lung cancer spread, or is it considered advanced?
- Have I received previous treatment for my advanced lung cancer?
- Do tests show my cancer has high levels of PD-L1 (over 50%)?
- Do my cancer tests show I don't have certain specific genetic changes?
- Am I at least 18 years old and generally in good health?
What does participation involve?
If you join this study, you'll receive one of the study treatments (Dato-DXd with rilvegostomig, rilvegostomig alone, or pembrolizumab). You won't get to choose which one you receive; it's decided by chance, like flipping a coin. You'll have regular hospital visits for treatments, blood tests, scans, and check-ups to see how you're responding and to monitor any side effects. The study will last for a period while you are benefiting from the treatment or until your cancer progresses or you experience side effects that make it necessary to stop. After stopping treatment, you will continue to have follow-up appointments, typically for several years, to track your health and long-term outcomes. The total duration of your participation could vary, from several months to several years if you continue to do well.
Potential risks and benefits
Locations (281)
- Research SiteVerified postcodeAnchorage, United States· Recruiting
- Research SiteVerified postcodeTucson, United States· Recruiting
- Research SiteVerified postcodeLittle Rock, United States· Recruiting
- Research SiteVerified postcodeSpringdale, United States· Recruiting
- Research SiteVerified postcodeAnaheim, United States· Recruiting
- Research SiteVerified postcodeBeverly Hills, United States· Recruiting
- Research SiteVerified postcodeFountain Valley, United States· Recruiting
- Research SiteVerified postcodeNewport Beach, United States· Suspended
- Research SiteVerified postcodeClermont, United States· Recruiting
- Research SiteVerified postcodeGainesville, United States· Recruiting
- Research SiteVerified postcodeMiami Beach, United States· Recruiting
- Research SiteVerified postcodeOrange City, United States· Recruiting
Common questions
What is PD-L1 and why is it important for this study?
PD-L1 is a protein found on some cancer cells. High levels of PD-L1 might mean certain treatments, like the ones in this study, could be more effective. Your doctor will test for it.
What does 'first-line treatment' mean?
First-line treatment means this study is for people who have not yet received any treatment for their advanced lung cancer. It's the initial treatment they would receive.
Will I know which treatment I'm receiving?
Yes, this is an 'open-label' study, which means both you and your study doctor will know which treatment you are receiving.
What are 'actionable genomic alterations'?
These are specific changes in your cancer's genes that can be targeted by other existing medicines. This study is for people whose cancer *doesn't* have these particular changes.
Can I continue with my usual doctor while in the study?
Yes, you will still have your regular doctors, and the study team will work closely with them to ensure you receive the best care.
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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