Phase 1b Study of Dato-DXd in Combination with Pembrolizumab with or without Platinum Chemotherapy in Advanced or Metastatic Non-Small Cell Lung Cancer
This research is testing a new way to treat non-small cell lung cancer that has spread or is advanced. Doctors are trying out a new drug called Dato-DXd alongside a well-known cancer medicine called pembrolizumab. For some patients, standard chemotherapy might also be added to this mix. This is a very early study (Phase 1b), which means the main goal is to check if these treatments are safe together and to find the best doses. It’s also important to see how the body reacts to these medicines. The study hopes to find a good new option for people with this type of lung cancer. Only adults aged 18 and over, both men and women, can take part.
At a glance
What is this study about?
This clinical trial is designed for people living with non-small cell lung cancer, which is the most common type of lung cancer. Specifically, it's for those whose cancer has either advanced within the body or has spread to other parts (doctors call this 'metastatic'). The main purpose of this study is to explore a new treatment approach.
The researchers are combining a new experimental drug, called Dato-DXd, with another medicine you might have heard of, pembrolizumab. Pembrolizumab is a type of immunotherapy, which helps your body's own immune system fight cancer. In some cases, the study will also look at adding standard chemotherapy to this combination. Because this is an early-stage study (Phase 1b), the doctors are primarily focused on understanding if these medications can be given safely together, what the possible side effects are, and to determine the best doses to use. They will also be looking to see if there are any early signs that the combination might be effective against the cancer.
Finding new and more effective treatments for advanced lung cancer is very important. Studies like this help doctors learn more about diseases and discover new ways to help patients. While this is an early study, the information gathered will be crucial for deciding if these treatments should be studied further in larger groups of people.
Key takeaways
- This study is for advanced or metastatic non-small cell lung cancer.
- It tests a new drug (Dato-DXd) with an existing one (pembrolizumab), sometimes adding chemotherapy.
- It's an early-stage study focused on safety and finding the right dose.
- Participants must be 18 years or older, both men and women.
- Taking part gives access to potentially new treatments but also carries risks of side effects.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women are welcome to take part. The study is specifically for people who have been diagnosed with non-small cell lung cancer that has either gotten worse or spread to other parts of the body.
There will also be other specific health requirements that only your doctor can assess. These might include how well your organs are working, if you have certain other health conditions, or if you've had specific treatments in the past. These detailed checks are needed to make sure the study is safe for you and that the results are as accurate as possible. Your cancer specialist will be able to tell you if your individual circumstances match what the study is looking for.
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?
- Have you been diagnosed with non-small cell lung cancer?
- Has your lung cancer advanced or spread to other parts of your body?
- Are you able to manage regular hospital visits for treatments and checks?
What does participation involve?
If you decide to join this study, you would receive the study medications (Dato-DXd, pembrolizumab, and possibly chemotherapy) as directed by the research team. This would involve regular visits to the clinic for treatments, check-ups, and to have various tests done. These tests might include blood tests, scans (like X-rays or CT scans) to see how the cancer is responding, and physical examinations.
The frequency of visits and tests would depend on the specific treatment plan for you and the stage of the study. You would be closely monitored for any side effects. After your main treatment period, there would likely be a follow-up period where you would continue to have check-ups to see your long-term health and how your cancer is doing. The total length of your participation would be explained fully by the study team, and it can vary from person to person.
Potential risks and benefits
Locations (2)
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Common questions
What type of lung cancer is this study for?
This study is specifically for people with non-small cell lung cancer that is advanced or has spread.
What are the main medicines being tested?
The main medicines are an experimental drug called Dato-DXd and a common cancer medicine called pembrolizumab, sometimes with chemotherapy.
Why is this an 'early stage' study?
Being an early stage (Phase 1b) means the main goal is to check how safe the treatments are together and to find the best dose, rather than primarily proving how well they work.
Will I definitely get the new treatment combination?
If you join the study, you will receive the experimental treatment combination as part of the study plan. There is no placebo arm in this study, meaning everyone gets active treatment.
How old do I need to be to join?
You need to be at least 18 years old to take part in this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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