IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-based Chemotherapy in Patients with EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy
This clinical trial, called IZABRIGHT-Lung01, is designed for adults with non-small cell lung cancer that has a specific genetic change (EGFR mutation). These patients have already been treated with other targeted therapies, but their cancer has unfortunately started to grow again. The study is comparing a new experimental drug, Izalontamab Brengitecan, with standard chemotherapy. The main goal is to find out if the new drug can stop the cancer from getting worse for longer than chemotherapy, and if it helps people live longer. It's a two-part study: initially, researchers will determine the best dose of the new drug, then they will fully compare its effectiveness and safety against traditional treatments.
At a glance
What is this study about?
This study is looking into a type of lung cancer called non-small cell lung cancer, specifically in people who have a particular genetic fault in their cancer called an EGFR mutation. If you have this type of cancer, you might have already received treatments that target this mutation, but over time, the cancer can become resistant to these medications.
Researchers are trying to find better ways to treat this situation. In this study, they are comparing a new experimental drug called Izalontamab Brengitecan with standard chemotherapy treatments often used at this stage. The main aim is to see if the new drug can keep the cancer from growing for a longer period and ultimately help people live longer. They will also be looking at how safe the new drug is and what side effects it might cause.
This study is important because it could lead to a new treatment option for people whose EGFR-mutated lung cancer has unfortunately progressed. By comparing a new drug to existing treatments, doctors can learn which approach offers the best chance for patients, bringing hope for improved outcomes.
Key takeaways
- Study for EGFR-mutated non-small cell lung cancer.
- Compares a new drug (Izalontamab Brengitecan) with standard chemotherapy.
- Aims to see if the new drug controls cancer for longer and improves survival.
- Patients randomised to treatment groups, but both patient and doctor will know which treatment you receive.
- Requires previous treatment with an EGFR inhibitor, with cancer progression.
Who may be eligible?
To join this study, you must be an adult aged 18 or over. This study includes both men and women.
Firstly, you need to have been diagnosed with non-small cell lung cancer that has a specific genetic change, known as an EGFR mutation. This is a crucial requirement for taking part.
Additionally, your cancer must have previously responded to, but then progressed, after taking a treatment specifically designed to target the EGFR mutation.
- Are you 18 years old or older?
- Do you have non-small cell lung cancer with an EGFR mutation?
- Has your cancer started to grow again after previous targeted EGFR treatment?
- Are you able to travel to a study site for regular 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 in this study, you would be randomly assigned to receive either the new drug (Izalontamab Brengitecan) or standard chemotherapy. This means neither you nor your doctor can choose which treatment you receive, it's like flipping a coin.
You would have regular visits to the hospital for your treatment and check-ups. These visits will involve various tests, such as blood tests, scans (like CT scans) to monitor your cancer, and physical examinations. The doctors and nurses will also ask you how you are feeling and if you are experiencing any side effects.
The duration of your participation in the study will depend on how your cancer responds to treatment. You would continue receiving the study treatment as long as it is benefiting you and you are not experiencing severe side effects. After stopping treatment, there would also be a follow-up period where researchers continue to monitor your health and any long-term effects.
Potential risks and benefits
Locations (10)
- —Poland
- —Germany
- —Italy
- —Norway
- —Netherlands
- —Belgium
- —Romania
- —France
- —Greece
- —Spain
Common questions
What is an EGFR mutation?
It's a specific change in the genes of your lung cancer cells that can make the cancer grow. Some treatments are designed to target this mutation.
What does 'randomized' mean?
It means you'll be put into one of two treatment groups by chance, like drawing lots. Neither you nor your doctor can choose which group you're in.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, which means you and your doctor will know whether you are receiving the new drug or chemotherapy.
What is the new drug, Izalontamab Brengitecan?
It's an experimental drug (BMS-986507) that is being tested in this trial to see if it's an effective new treatment for this type of lung cancer.
What happens if I stop taking part?
You can leave the study at any time. Your decision won't affect your future medical care, and your doctors will discuss other treatment options with you.
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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