A Phase IB Study to determine efficacy and safety of Durvalumab and/or novel anti-cancer agents, with or without chemotherapy, in patients with previously untreated NSCLC
This is an early-stage research study, called a Phase 1B trial, for adults aged 18 and over who have non-small cell lung cancer that has spread to other parts of the body. The main goal is to find out if new ways of using a drug called Durvalumab, either on its own, with other new cancer medicines, or alongside chemotherapy, are safe and have early signs of working. Because it's an early study, researchers are carefully checking for any side effects and seeing how the body reacts to these treatments. This kind of research helps us learn more about potential new ways to treat this type of lung cancer in the future.
At a glance
What is this study about?
You might have heard about clinical trials – they are research studies that test new medicines or treatments to see how well they work and if they are safe. This particular study is for people who have a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body. When cancer spreads, doctors call it 'metastatic'.
The main medicine being looked at in this study is called Durvalumab. Researchers want to understand if using Durvalumab in new ways, sometimes combined with other new cancer treatments or with standard chemotherapy, can help people with this type of lung cancer. Think of it like trying out a new recipe – you try different ingredients and combinations to see what tastes best and what works.
This is a 'Phase 1B' study, which means it's one of the first steps in testing a new treatment in people. The main focus at this stage is usually on safety – making sure the treatments aren't causing too many problems. Researchers also look for early signs that the treatments might be helping. The aim is to gather information that will help decide if these treatments should be studied further in larger trials.
Key takeaways
- This is an early-stage study for advanced lung cancer.
- It's testing a drug called Durvalumab, alone or with other treatments.
- The main goals are to check safety and look for early signs of effectiveness.
- It's for adults aged 18 and over with 'metastatic non-small cell lung cancer' who haven't had previous treatment for this stage.
- Participation involves regular hospital visits, tests, and follow-up.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. Researchers are looking for people who have non-small cell lung cancer that has spread to other parts of the body, and who haven't started treatment for this specific stage of their cancer yet.
There will be other detailed health checks to make sure the treatment is suitable and safe for you. These might include blood tests, health scans, and checking any other medical conditions you have. These checks are important to protect your health and to make sure the study results are clear.
It’s important to remember that these are just the basic requirements. A doctor or research nurse involved in the study will be able to tell you all the specific details and whether you meet all the criteria to take part.
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 has spread?
- Have you not yet received treatment specifically for your widespread lung cancer?
- Are you willing to have regular medical check-ups and tests?
- Do you understand that this is a research study with potential benefits and risks?
What does participation involve?
If you decide to take part, you would receive the study treatment, which might be Durvalumab on its own, with other experimental drugs, or with chemotherapy. You would have regular appointments at the hospital or clinic. These visits would involve check-ups, blood tests, and scans to monitor your health and see how the treatment is affecting your cancer. These appointments would happen over a set period, and you would also have follow-up visits after the main treatment period to see how you are doing long-term. The total duration of your participation would be explained fully by the study team, but it includes the treatment time and the follow-up period.
Potential risks and benefits
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Common questions
What is non-small cell lung cancer (NSCLC)?
It's the most common type of lung cancer, and it's called 'non-small cell' because of how the cancer cells look under a microscope.
What does 'metastatic' mean?
It means the cancer has spread from where it started in the lung to other parts of your body.
What is Durvalumab?
Durvalumab is a type of medicine that helps your own immune system fight cancer cells. It's a type of immunotherapy.
What does 'Phase 1B' mean for me?
It means this is one of the earliest stages of testing a new treatment in people. The main goals are to check its safety and find the right dose, rather than expecting a cure.
Will I know if I'm getting the active drug or a dummy pill?
In this specific study, you will be receiving an active drug or combination. There will not be a dummy pill (placebo) in this trial.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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