A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Given Concurrently with Platinum-based Chemoradiation Therapy in Patients with Locally Advanced, Unresectable Non-small Cell Lung Cancer (Stage III) (PACIFIC2)
This important study, called PACIFIC2, is testing a new drug called Imfinzi alongside standard treatments (chemotherapy and radiation therapy) for a specific type of lung cancer. This is for people whose lung cancer has grown and spread locally, but can't be fully removed with an operation. The study wants to find out if adding Imfinzi helps stop the cancer from getting worse and helps people live longer. They will carefully compare patients who receive Imfinzi with those who receive a dummy drug (placebo) to see the difference. This type of study helps doctors understand if new treatments are safe and effective, and could potentially offer a new way to treat this challenging form of cancer.
At a glance
What is this study about?
This study is for adults in the UK who have a certain type of lung cancer called non-small cell lung cancer. Specifically, it's for those whose cancer is considered 'locally advanced' – meaning it has grown into nearby tissues or lymph nodes, but hasn't spread to distant parts of the body. Also, it's for people whose cancer can't be completely removed by surgery.
The main goal of this study is to see if a drug called Imfinzi, when given along with standard cancer treatments (like chemotherapy and radiation therapy), can help people live longer and keep their cancer from getting worse. Imfinzi is an immunotherapy, which means it helps your body's own immune system fight the cancer. Researchers will carefully compare new medicines to a dummy drug (called a placebo) to see if it makes a real difference. They will measure how long people live without their cancer growing and also look at their overall health and quality of life.
Studies like PACIFIC2 are called 'Phase III' trials. This means they are a very important part of testing new medicines, often involving many people around the world. The results help doctors decide if new treatments are better than what's currently available, and if they should be approved for wider use.
Key takeaways
- This study is for adults with a specific type of lung cancer that can't be removed by surgery.
- It tests a new drug, Imfinzi, along with standard chemotherapy and radiation.
- The main goal is to see if Imfinzi helps people live longer and keeps cancer from growing.
- Participants will be randomly assigned to receive either Imfinzi or a dummy drug (placebo).
- All participants will receive standard cancer treatments.
- You can stop participating in the study at any time.
Who may be eligible?
To join this study, you would generally need to be an adult, aged 18 or older.
You would need to have been diagnosed with a specific type of lung cancer called non-small cell lung cancer. Your cancer must be at a stage where it has spread locally but cannot be fully removed by surgery. Doctors will also check that you are well enough to take part in the study and that your organs (like your heart and kidneys) are working properly.
There might be other reasons why someone can't join, such as having certain other health conditions, or if you've already received specific cancer treatments in the past. Your doctor or the study team will go through all the detailed requirements with you to see if this study could be a good fit.
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.
- Are you 18 years old or older?
- Do you have non-small cell lung cancer that is locally advanced?
- Has your doctor told you that your lung cancer cannot be fully removed by surgery?
- Are you able to undergo chemotherapy and radiation therapy?
What does participation involve?
If you decide to take part in this study, you would first have a number of tests to check if you are suitable. If you are, you would be randomly assigned to one of two groups: one group would receive the new drug Imfinzi along with standard chemotherapy and radiation, and the other group would receive a dummy treatment (placebo) along with the same standard chemotherapy and radiation. Neither you nor your study doctor would know which group you are in.
You would have regular hospital visits for treatments, blood tests, and scans to monitor your health and how the treatment is working. This could involve multiple visits over several months or even longer, depending on your treatment plan and how you respond. The study team would explain the exact schedule in detail before you make any decisions. There will also be follow-up appointments after your main treatment period to keep an eye on your progress.
Potential risks and benefits
Locations (2)
- —UnverifiedPoland
- —UnverifiedHungary
Common questions
What is Imfinzi?
Imfinzi is a type of immunotherapy drug that helps your body's immune system find and fight cancer cells.
What does 'locally advanced, unresectable' mean?
It means the cancer has spread within the area of the lung and nearby tissues, but not to distant parts of the body, and it cannot be fully removed by surgery.
What is a placebo?
A placebo is a dummy treatment that looks just like the real drug but contains no active medicine. It helps researchers compare how effective the new drug really is.
Will I still receive standard cancer treatment?
Yes, all participants will receive the standard treatments for this type of lung cancer, which usually include chemotherapy and radiation therapy.
How long does the study last?
The length of the study varies for each person, depending on their treatment plan and how they respond. It usually involves several months of active treatment and follow-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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