A phase III trial of a De-escalated Immune-strategy During first-line treAtment in patients with metastatic non-small Cell lung cancer (NSCLC): DIDaC
This study, called DIDaC, is for individuals with a type of lung cancer known as non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants must have already started treatment with immunotherapy and responded well to it for at least six months. The main goal is to see if reducing the amount of immunotherapy given after this initial period is still effective in keeping the cancer under control. By potentially using less treatment, the study hopes to find out if patients can maintain their quality of life with fewer side effects. Researchers will compare different treatment plans using KEYTRUDA and ALIMTA to see which is best for stopping the cancer from growing.
At a glance
What is this study about?
This study is called DIDaC, and it focuses on people living with advanced non-small cell lung cancer (NSCLC). This is a type of lung cancer that has spread to other parts of the body. Often, people with this kind of cancer are treated with medicines called immunotherapy, which help the body's own immune system fight the cancer. The study is particularly for those who have responded well to their initial immunotherapy treatment – meaning the treatment has been working for at least six months.
The main idea behind DIDaC is to explore if it's possible to "dial down" the amount of immunotherapy treatment after a good initial response. Standard care usually involves continuing immunotherapy at a set dose. This study wants to find out if a reduced treatment plan can still keep the cancer under control effectively, potentially leading to fewer side effects and a better quality of life for patients. Researchers will be looking at how long it takes for the cancer to show signs of growing again, or if patients sadly pass away.
To do this, participants will be given one of two treatment plans involving medicines called KEYTRUDA and ALIMTA. The study will carefully compare these plans for up to 18 months to see which approach offers the best balance of effectiveness and patient well-being. It's an important step in understanding how to best manage advanced lung cancer and improve the lives of those affected.
Key takeaways
- Study for advanced lung cancer patients who responded well to initial immunotherapy.
- Investigates if less treatment can still be effective, potentially reducing side effects.
- Compares two treatment plans involving KEYTRUDA and ALIMTA.
- Focuses on how long cancer stays controlled and overall patient well-being.
- Participation involves regular hospital visits, tests, and questionnaires.
- You can leave the study at any time.
Who may be eligible?
This study is looking for adults aged 18 or older, and it's open to both men and women. The most important requirement is that you must have advanced non-small cell lung cancer that has spread to other parts of your body.
Crucially, you would have already started treatment with immunotherapy as your first treatment for this advanced cancer. To be suitable for this study, your initial immunotherapy treatment must have been working well, and your cancer must not have grown worse for at least six months since you started that treatment.
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 advanced non-small cell lung cancer that has spread?
- Have you been on immunotherapy as your first treatment for this advanced cancer?
- Has your immunotherapy treatment been working well for at least the past six months (your cancer hasn't grown worse)?
- Are you generally feeling well enough to participate in a study?
- Are you able to attend regular hospital visits for treatments and assessments?
What does participation involve?
If you join this study, you'll be randomly assigned to one of two treatment groups, much like flipping a coin, so neither you nor your doctor can choose. You will receive either the standard ongoing treatment or a de-escalated treatment plan, both involving medicines called KEYTRUDA and ALIMTA, given through an infusion (drip). You will have regular visits for these treatments and check-ups.
During these visits, doctors will monitor your health closely through blood tests, scans, and physical examinations. You will also be asked to fill out questionnaires about your quality of life at the start of the study and then every three months. The study will track your progress for up to 18 months after you join, closely watching how your cancer responds to the treatment.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is non-small cell lung cancer?
It's the most common type of lung cancer, and 'metastatic' means it has spread to other parts of the body.
What does 'immunotherapy' mean?
Immunotherapy is a type of medicine that helps your body's own immune system find and fight cancer cells.
What does 'de-escalated' treatment mean?
It means trying to reduce the amount or intensity of treatment while still aiming to keep the cancer under control.
Will I know which treatment group I'm in?
Typically, in this kind of study, you wouldn't know which group you are in to ensure fair results.
How long will I be involved in the study?
You'll be followed for up to 18 months to see how the treatment works.
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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