Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)
This research study, called IZABRIGHT-Lung01, is looking into a new treatment for non-small cell lung cancer. Specifically, it's for people whose cancer has a particular gene change, known as an "EGFR mutation," and has continued to grow despite earlier treatments like targeted therapies. The study compares a new drug, Izalontamab Brengitecan (which we'll call Iza-bren for short), with a common chemotherapy treatment that involves a combination of either carboplatin or cisplatin, along with pemetrexed. The main aim is to find out if Iza-bren is more effective or safer than the standard chemotherapy for managing this type of lung cancer. Researchers are also interested in how these treatments affect quality of life. This is a large study (Phase 2 and 3) involving many patients.
At a glance
What is this study about?
This study is looking for better ways to treat a specific type of lung cancer called non-small cell lung cancer (NSCLC). This particular type of NSCLC has a change in a gene called EGFR. This gene change can make the cancer grow and spread. Doctors often treat this type of cancer with special medicines called EGFR TKIs, but sometimes, after a while, the cancer starts to grow again, even with these treatments. This study is for people in that situation.
The study compares a new experimental medicine, Izalontamab Brengitecan (or Iza-bren), with a standard chemotherapy treatment. The chemotherapy involves a combination of two drugs: either carboplatin or cisplatin, given with pemetrexed. Both of these are established treatments for lung cancer. Researchers want to see if Iza-bren works better than the standard chemotherapy to stop the cancer from growing, shrink the tumors, and help people live longer and feel better.
Taking part in a study like this helps doctors learn more about cancer and find new, more effective treatments. While the new treatment is experimental, all participants will receive active cancer treatment, either the new drug or the established chemotherapy.
Key takeaways
- Targets specific EGFR-mutated non-small cell lung cancer.
- Compares a new drug (Iza-bren) with standard chemotherapy.
- For patients whose cancer grew despite previous targeted therapy.
- Aims to find more effective and safer treatment options.
- Participation involves regular treatments, tests, and monitoring.
Who may be eligible?
To be able to take part in this study, you would need to have non-small cell lung cancer that isn't able to be cured by surgery or radiation alone. Your cancer must also have a specific gene change (EGFR mutation, either an exon 19 deletion or an L858R mutation). It's also important that your cancer has started to grow again, despite having been treated previously with a newer type of targeted therapy for EGFR mutations (like osimertinib, furmonertinib, or lazertinib).
You must be well enough to receive a standard chemotherapy treatment that combines a platinum-based drug (like cisplatin or carboplatin) with pemetrexed. This means your body, including organs like your kidneys, liver, and bone marrow, must be functioning well. There are some situations that would prevent you from joining, such as if your cancer has spread to your brain's lining or spinal cord, or if you have other serious medical conditions that are not under control. The study team will review all your medical information carefully to see if this study is right 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.
- I have non-small cell lung cancer.
- My cancer has a specific EGFR gene change (exon 19 deletion or L858R).
- My cancer has started to grow again after previous targeted EGFR TKI treatment.
- My doctors think I am well enough to have chemotherapy.
- I do not have cancer spread to the brain lining or spinal cord.
- I am 18 years old or older.
What does participation involve?
If you join this study, you will be randomly assigned to receive either the new medicine (Iza-bren) or the standard chemotherapy combination. This is like flipping a coin, so neither you nor your doctor can choose which group you are in. You will likely have regular visits to the hospital or clinic for your treatments, which will be given through a drip (intravenously). During these visits, you'll have blood tests, scans (like X-rays or CT scans) to check how the treatment is working, and examinations.
The total length of your participation will depend on how your cancer responds to the treatment. You will continue with the study treatment for as long as it is helping you and you are tolerating it well. After you stop the main treatment, you will still have follow-up visits or phone calls for some time to monitor your health and gather important information for the study.
Potential risks and benefits
Locations (186)
- Local Institution - 0279Verified postcodeIrvine, United States· Not yet recruiting
- Local Institution - 0154Verified postcodeOrange, United States· Not yet recruiting
- Shaw Cancer CenterVerified postcodeEdwards, United States· Recruiting
- Local Institution - 0085Verified postcodeGainesville, United States· Withdrawn
- Local Institution - 0142Verified postcodePembroke Pines, United States· Not yet recruiting
- Piedmont HealthcareVerified postcodeAtlanta, United States· Recruiting
- John B Amos Cancer CenterVerified postcodeColumbus, United States· Recruiting
- Rush University Medical CenterVerified postcodeChicago, United States· Recruiting
- Dana-Farber Cancer InstituteVerified postcodeBoston, United States· Recruiting
- Washington University School of MedicineVerified postcodeSt Louis, United States· Recruiting
- Renown Regional Medical CenterVerified postcodeReno, United States· Recruiting
- Perlmutter Cancer Center at NYU Langone Hospital - Long IslandVerified postcodeMineola, United States· Recruiting
Common questions
What does 'EGFR-mutated' mean?
It means your lung cancer cells have a specific change in a gene called EGFR, which often helps the cancer grow. Targeted medicines are designed to block this growth.
What is 'Iza-bren'?
Iza-bren is a new, investigational medicine being tested in this study to see if it's an effective treatment for your type of lung cancer.
What is 'Platinum-Pemetrexed'?
This is a common chemotherapy treatment combining two drugs (either cisplatin or carboplatin, plus pemetrexed) often used for lung cancer.
Will I definitely get the new drug?
No, you will be randomly assigned to either receive the new drug or the standard chemotherapy. It’s like drawing straws, ensuring fairness in comparing the treatments.
How long will the study last for me?
Your participation will continue as long as the treatment is helping you and you are not experiencing severe side effects. There will also be a follow-up period afterward.
How to find out more
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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