A trial to find out how well CVHNLC works at different dose levels and how safe it is in combination with pembrolizumab in patients with lung cancer that cannot be completely cured.
This research study is for people who have a type of lung cancer called metastatic squamous non-small cell lung cancer, which means it has spread and can't be completely cured with surgery. The study is testing a new drug, which we're calling CVHNLC, alongside a common treatment called pembrolizumab. It's a very early-stage study (Phase I), which means it's one of the first times this new drug is being given to people. The main goals are to find out the safest dose of CVHNLC to give, to see how well people tolerate it, and to check for any side effects. By doing this, researchers hope to understand if this new combination could be a helpful treatment option in the future.
At a glance
What is this study about?
This study is looking into a new treatment for a specific type of lung cancer. This cancer is called 'metastatic squamous non-small cell lung cancer,' which simply means it's a kind of lung cancer that has spread to other parts of the body and can't be fully removed with an operation.
The researchers want to test a new medicine, which for now we're calling CVHNLC, in combination with a drug that's already used for lung cancer, called pembrolizumab. Think of it like trying out a new ingredient in a well-known recipe to see if it makes it even better. This is a very early study, called a Phase I trial. This means it's one of the first times this new medicine is being given to people. The main purpose at this stage is not to cure the cancer, but to find out the best and safest dose of CVHNLC to give, and to see if it causes any serious side effects when combined with pembrolizumab.
By carefully checking how people react to the medicine, the researchers hope to learn if this new combination holds promise for helping people with this type of lung cancer in the future. If this early phase goes well, it could lead to bigger studies to further test its effectiveness.
Key takeaways
- This study is for a type of lung cancer that has spread.
- It's testing a new medicine (CVHNLC) with an existing one.
- It's a very early-stage study to find a safe dose.
- Open to adults 18 and over, both men and women.
- Participation involves regular hospital visits and check-ups.
Who may be eligible?
To join this study, you must be at least 18 years old – there's no upper age limit. The study is open to both men and women.
You would need to have been diagnosed with metastatic squamous non-small cell lung cancer, which means your lung cancer has spread and can't be cured by a complete operation. The doctors running the study will carefully check your medical history and test results to make sure this study is right for you and that you meet all the necessary health requirements.
- Are you 18 years old or older?
- Have you been diagnosed with squamous non-small cell lung cancer that has spread?
- Has a doctor told you that your lung cancer cannot be completely cured by surgery?
- Are you able to attend regular hospital appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll have regular visits to the hospital or clinic. These visits will involve blood tests, physical examinations, and possibly scans to see how your body is responding to the treatment and to check for any side effects. You will receive the study medication, which is the new drug CVHNLC plus pembrolizumab, as directed by the study doctors. The doctors and nurses will explain exactly how and when you'll receive these medicines. You'll also have follow-up appointments after you stop taking the treatment to see how you're doing long-term. The total length of your participation will depend on how you respond to the treatment and the study plan, which the research team will explain in detail.
Potential risks and benefits
Locations (2)
- —Spain
- —France
Common questions
What is a Phase I trial?
A Phase I trial is the first stage where a new medicine is given to people. It's mainly to find a safe dose and look for side effects, not to prove it cures the disease.
What does 'metastatic' mean?
'Metastatic' means the cancer has spread from where it started to other parts of the body.
Will this study cure my cancer?
This early-stage study is focused on finding the safest dose and understanding how the new drug works, not on curing the cancer right now. Its aim is to see if it could be a helpful treatment in the future.
Can I still get other treatments while on this study?
The study team will discuss all your current treatments and explain which, if any, you would need to stop or pause to safely take part in the trial.
Who is paying for this study?
Information about the study's sponsor (who is funding it) would be provided by the research team when you speak to them.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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