TACTI-004, a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (PD-1 antagonist) and chemotherapy.
This study, called TACTI-004, is for people with advanced non-small cell lung cancer that has spread. Researchers want to see if combining a new drug, eftilagimod alfa, with two standard treatments – pembrolizumab (KEYTRUDA) and chemotherapy – can be more effective than current approaches. Eftilagimod alfa works by boosting the body's own immune system to fight cancer, while pembrolizumab also helps the immune system. Participants will be randomly placed into different groups, receiving either the new combination or existing treatments. The main goal is to find out if the new combination can help people live longer and, importantly, what impact it has on their quality of life. This is a large study (Phase III) designed to confirm if this new treatment approach is beneficial.
At a glance
What is this study about?
This clinical trial is looking at a new way to treat non-small cell lung cancer that has reached an advanced stage, meaning it has spread to other parts of the body. The study's main aim is to see if a new drug called eftilagimod alfa, when given alongside existing treatments like pembrolizumab (which you might know as KEYTRUDA) and standard chemotherapy, can improve how long people live compared to current treatments alone.
Eftilagimod alfa is designed to help your body's immune system fight the cancer more effectively. Pembrolizumab also works by helping your immune system, while chemotherapy directly attacks cancer cells. By combining these, researchers hope to create a more powerful and effective treatment.
This is a Phase III trial, which means it's a large study designed to confirm whether the new combination is genuinely better than what's currently available. Participants will be carefully monitored, and researchers will compare different treatment groups to understand the effects of the new combination on cancer growth, how long people live, and their overall quality of life during treatment. You will be assigned to a treatment group by chance, like flipping a coin, so neither you nor your doctor will choose which specific treatment you receive.
Key takeaways
- This study is for advanced non-small cell lung cancer.
- It combines a new drug (eftilagimod alfa) with existing treatments.
- The main goal is to see if the new combination helps people live longer.
- Participation involves regular hospital visits for treatments and checks.
- You'll be assigned a treatment group by chance (randomised).
- Your quality of life will be monitored throughout the study.
Who may be eligible?
To be considered for this study, you must be 18 years old or older. The study is open to both men and women.
The specific type of cancer you have is important: it must be non-small cell lung cancer that has spread to other parts of the body. Your medical team will perform tests to confirm this and ensure your overall health meets certain criteria for safely participating in the trial, as the treatments involved can be strong.
There might be other health conditions or previous treatments that would prevent you from joining, as these could affect how the new drugs work or put your health at risk. Your doctor will carefully review your full medical history to see if this study is suitable for you.
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 advanced non-small cell lung cancer that has spread?
- Are you able to attend regular hospital visits for treatment and check-ups?
- Are you willing for your treatment group to be chosen by chance (randomly)?
- Is your general health good enough to receive strong cancer treatments?
What does participation involve?
If you decide to join this study, you will be randomly assigned to one of several treatment groups. This is like drawing names from a hat, ensuring fairness in how treatments are given out. You will receive specific medications, which might include the new drug eftilagimod alfa, a drug called pembrolizumab (KEYTRUDA), and/or chemotherapy (paclitaxel, cisplatin, carboplatin, or pemetrexed). Some groups may also receive a placebo, which looks exactly like eftilagimod alfa but doesn't contain any active medicine, to help researchers understand the true effects of the new drug.
You will have regular hospital visits for your treatments, which are given directly into a vein (infusion). During these visits, the study team will carry out health checks, such as blood tests, physical exams, vital sign measurements, and heart tracings (ECGs), to monitor your health and the treatment's effects. They will also repeatedly scan your body to check how your cancer is responding.
Throughout the study, you will be asked to complete questionnaires about your quality of life. The total duration of your active treatment will depend on how your cancer responds, but you will be followed up for a number of years even if you stop treatment, to track your overall health and survival. The team will explain the full schedule of visits and procedures to you in detail.
Potential risks and benefits
Locations (15)
- —UnverifiedRomania
- —UnverifiedLithuania
- —UnverifiedBulgaria
- —UnverifiedLatvia
- —UnverifiedGreece
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedBelgium
- —UnverifiedHungary
- —UnverifiedCroatia
- —UnverifiedGermany
- —UnverifiedPortugal
Common questions
What is 'randomised' treatment?
Randomised means you are assigned to a treatment group by chance, like flipping a coin. Neither you nor your doctor chooses which specific treatment you receive in the study.
What is a 'placebo'?
A placebo looks exactly like the actual drug but contains no active medicine. It helps researchers understand the real effects of the drug being studied.
What is 'advanced/metastatic' cancer?
This means the lung cancer has grown beyond its original site and spread to other parts of your body.
Does this study involve standard chemotherapy?
Yes, some treatment groups in this study will receive standard chemotherapy alongside other drugs. Your specific treatment plan will be determined randomly.
What does Phase III mean?
Phase III means this is a large, advanced study comparing a new treatment to existing ones to confirm if it's safe and more effective before it can be widely approved.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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