A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab plus Olaparib Combination Therapy Compared with Durvalumab Monotherapy as Maintenance Therapy in Patients whose Disease has not Progressed Following Standard of Care Platinum-Based Chemotherapy with Durvalumab in First Line Stage IV NonSmall Cell Lung Cancer (ORION)
This research study, called ORION, is for people with a type of advanced lung cancer (non-small cell lung cancer) where their cancer hasn't grown after their first chemotherapy treatment alongside Durvalumab. We are testing a new approach where some patients receive a combination of two medicines, Durvalumab (known as IMFINZI) and Olaparib (known as Lynparza), while others receive Durvalumab by itself. The main aim is to find out if the combination treatment can keep the cancer under control for longer, meaning less chance of it growing or coming back. We'll also look at how long people live overall, how well the treatment shrinks the cancer, and any side effects. This is a Phase II study, meaning we are exploring whether this new combination shows promise for future, larger studies.
At a glance
What is this study about?
Imagine your body as a house, and cancer as a weed that's trying to take over. When you have advanced lung cancer, it means these 'weeds' have spread. Doctors often use chemotherapy to try and get rid of as many as possible. This study is for people who have just finished their first round of chemotherapy, and crucially, their cancer hasn't gotten worse. It's like having just treated the main weed patch, and now we want to keep new weeds from growing back.
We're testing two different approaches to 'maintenance therapy' – treatments given after the first main treatment to keep the cancer under control. One group of people will receive a medicine called Durvalumab. This medicine helps your body's immune system fight the cancer. Another group will receive Durvalumab plus another medicine called Olaparib. Olaparib works differently to Durvalumab; it targets specific ways cancer cells repair themselves, making it harder for them to survive. We want to see if adding Olaparib to Durvalumab is more effective at preventing the cancer from growing or spreading compared to Durvalumab alone. Think of it as a double attack on the lingering cancer cells.
The main thing we want to learn is if the combination of Durvalumab and Olaparib can help people live longer without their cancer getting worse. We also want to understand if it helps people live longer overall, how the medicines affect the size of the cancer, and importantly, look at any side effects people might experience. This is a 'Phase II' study, which means we're in the middle stages of testing. We're carefully exploring if this new combination treatment shows enough promise to be studied in even larger numbers of patients in the future.
Key takeaways
- This study is for people with advanced lung cancer that hasn't worsened after initial treatment.
- It compares two medicines: Durvalumab alone versus Durvalumab plus Olaparib.
- The main aim is to see if the combination keeps cancer under control for longer.
- Participation involves regular hospital visits for treatments, scans, and check-ups.
- You won't know which treatment you are receiving (it's 'double-blind').
- It's a Phase II study, exploring the potential of a new combination.
Who may be eligible?
This study is looking for volunteers who have a specific type of advanced lung cancer. It's called Stage IV Non-Small Cell Lung Cancer. Importantly, your cancer should not have specific genetic changes called 'EGFR mutations' or 'ALK fusions'. Your doctor would have checked for these. Also, people can only join if their cancer has responded well to their initial chemotherapy treatment with Durvalumab, meaning it hasn't grown or spread further after that treatment.
To be considered for this study, you must be at least 18 years old. Both men and women can take part. There's no upper age limit, meaning older adults are welcome to participate if they meet all other criteria. The research team will carefully review your medical history and test results to ensure you fit all the requirements for taking part.
It's important to remember that even if you meet these general points, there might be other specific health conditions or medications that would prevent you from joining. The study doctor will be able to tell you exactly if this study is suitable for you after reviewing your full medical information.
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.
- Have I been diagnosed with Stage IV Non-Small Cell Lung Cancer?
- Does my cancer lack EGFR mutations and ALK fusions? (My doctor would know this).
- Has my cancer not grown or spread after my first chemotherapy with Durvalumab?
- Am I at least 18 years old?
- Am I able to travel to study appointments?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to one of two treatment groups, like flipping a coin. You wouldn't choose which treatment you get, and neither would your doctor. One group will receive Durvalumab alone, and the other will receive Durvalumab plus Olaparib. You, your doctor, and the study team won't know which treatment you are receiving – this is called 'double-blind' to make sure the results are as fair as possible.
Both medicines are given in different ways. Durvalumab is an infusion, meaning it's given through a drip into your vein. Olaparib is a tablet you take by mouth. You would have regular hospital visits for these treatments and check-ups. During these visits, doctors would do physical exams, take blood samples, and conduct scans (like CT scans) to see how the cancer is responding. They would also ask you about any side effects you might be experiencing and how you're feeling overall, using questionnaires to track your quality of life and symptoms.
These visits would continue as long as the treatment is working and you are tolerating it well. After you stop the study treatment, usually because the cancer has grown or for other reasons, the study team will continue to follow up with you for a period to see how you are doing overall. The total time you participate in the study will vary from person to person depending on how long they receive treatment and the follow-up period, but it can last for several years.
Potential risks and benefits
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Common questions
What kind of lung cancer is this study for?
This study is for a specific type of advanced lung cancer called Stage IV Non-Small Cell Lung Cancer, but only if your cancer doesn't have certain genetic changes (EGFR mutations or ALK fusions).
What does 'maintenance therapy' mean?
Maintenance therapy is treatment given after your initial chemotherapy to help keep your cancer from growing back or spreading further.
Will I know which treatment I'm getting?
No, this is a 'double-blind' study, meaning neither you nor your doctor will know if you're getting Durvalumab alone or the combination with Olaparib. This helps ensure fair results.
How long will I be in the study?
How long you participate depends on how well the treatment works for you and how long you tolerate it. There will also be a follow-up period after treatment stops, so it could be for several years.
What are the main goals of this study?
The main goals are to see if the combination treatment keeps the cancer under control for longer and if it helps people live longer overall, compared to Durvalumab alone.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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