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AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Phase I clinical trial of TG4050 combined with nivolumab in patients with Non-Small Cell Lung Cancer.

This research is looking at a new way to treat Non-Small Cell Lung Cancer, which is the most common type of lung cancer. The study is called a 'Phase I' trial, meaning it's one of the first times this new combination of treatments is being tested in people. Researchers want to see if combining two medicines, TG4050 and nivolumab, is safe for patients and how the body handles these drugs. Nivolumab is an immunotherapy drug that helps your own immune system fight cancer. We don't have much information about TG4050 yet, but this study will help us learn more about how these two work together. This type of research is really important for finding new and better ways to treat cancer in the future.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Transgene
Enrolment target
20
Start
03 Oct 2024

What is this study about?

This study is an important step in trying to find new and more effective treatments for Non-Small Cell Lung Cancer. This is the most common kind of lung cancer, and researchers are always working to improve how we care for people with this condition. This particular trial is looking at a new combination of two potential medicines: TG4050 and nivolumab.

Nivolumab is a type of treatment called immunotherapy. This means it works by helping your body's natural defence system (your immune system) recognise and fight cancer cells. It's already used for some cancers, but researchers are always looking for ways to make it work even better or for more people. TG4050 is a newer treatment, and we don't have much information about it yet, but this study will help us understand its role when combined with nivolumab.

Because this is a 'Phase I' trial, it means it's one of the very first times this specific combination is being tested in people. The main goal at this stage is to understand if the treatment is safe and to figure out the right dose. While it's early research, studies like this are crucial for developing future treatments that could make a real difference to patients' lives.

Key takeaways

  • This study is exploring a new combination of treatments for Non-Small Cell Lung Cancer.
  • It's a 'Phase I' trial, primarily focused on finding a safe dose and understanding how the new combination works.
  • The treatments being tested are TG4050 and nivolumab, an immunotherapy.
  • Participation involves regular hospital visits, tests, and closely monitored treatment.
  • There are potential benefits (access to new treatment) and risks (side effects, unknown effectiveness).
  • You can withdraw from the study at any time without affecting your normal care.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Because this is a specific type of cancer study, you must have been diagnosed with Non-Small Cell Lung Cancer. Other details about your health and the specific features of your cancer will be carefully checked by the study doctors to make sure this trial is right for you and safe for you to take part.

There will also be other medical requirements that aren't listed here. For example, your doctor will need to check your general health, including blood tests and scans, to make sure you can safely receive the study treatments. They will also look at your past medical history and any other medications you are taking to determine if you are suitable.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with Non-Small Cell Lung Cancer?
  3. Are you able to attend regular hospital appointments?
  4. Are you willing to follow the study's treatment and testing schedule?
  5. Are you generally in good health, aside from your cancer, as determined by a doctor?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll have several visits to the hospital or clinic. These visits will involve various tests and checks to monitor your health and how you're responding to the treatment. This will likely include blood tests, physical examinations, and possibly scans. You will receive the study treatments, TG4050 and nivolumab, according to a specific schedule set by the researchers.

The research team will explain how often you will need to come for appointments, how the medicines will be given, and what other tests will be involved. You'll be closely monitored throughout your time in the study. After your treatment period, there will also be follow-up appointments to check on your long-term health and any effects of the treatment. The total length of time you'll be involved in the study will be explained in full by the study team.

Potential risks and benefits

Participating in a clinical trial like this may offer potential benefits, such as receiving a new and experimental treatment that is not yet widely available. However, there are also potential risks involved. The new treatments may have side effects, some of which might be serious or unexpected, and there is no guarantee that the treatment will be effective for your cancer. You will be closely monitored for any side effects, and the medical team will always be available to address any concerns. It's very important to remember that joining a clinical trial is always your choice, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What is Non-Small Cell Lung Cancer?

It's the most common type of lung cancer, and it gets its name because the cancer cells look a certain way under a microscope. It can be treated in different ways depending on how advanced it is.

What does 'Phase I' mean for a clinical trial?

Phase I means it's an early-stage study focusing on safety. Researchers want to know if the new treatment is safe for people and what the right dose might be, rather than how effective it is yet.

What is nivolumab?

Nivolumab is a type of immunotherapy. It works by helping your body's immune system fight off cancer cells.

Will I get better if I join this study?

A Phase I study focuses on safety, and there's no guarantee that the treatment will make you better. However, it helps doctors learn important information to develop new treatments for the future.

Can I leave the study if I change my mind?

Yes, absolutely. You can choose to leave the study at any time, for any reason, and it won't affect your ongoing medical care.

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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