A Randomized, Open Label Phase II Clinical Trial of BMS-986012 in Combination with Carboplatin, Etoposide and Nivolumab as First-line Therapy in Extensive-Stage Small Cell Lung Cancer
This research study is investigating a new way to treat extensive-stage small cell lung cancer, which is a type of lung cancer that has spread. The study is called a Phase II clinical trial, which means researchers are checking how safe the new treatment is and if it shows promise in helping patients. The treatment involves giving patients a combination of four drugs: OPDIVO (Nivolumab), two common chemotherapy drugs called carboplatin and etoposide, and a new study drug called BMS-986012. Researchers will closely monitor patients for any side effects and see how well the treatment works in slowing down or stopping the cancer from growing. They also want to understand how long patients live and how much their cancer responds to this new combination.
At a glance
What is this study about?
This study is for people who have extensive-stage small cell lung cancer. This is a type of lung cancer that has spread to different parts of the body. Doctors are always looking for better ways to treat this condition.
In this study, researchers are testing a new combination of treatments. You might already know about some of these drugs. OPDIVO (also known as Nivolumab) is a medicine that helps your own immune system fight the cancer. Carboplatin and etoposide are common chemotherapy drugs that work by killing fast-growing cancer cells. The new part of the treatment is a drug called BMS-986012. The study aims to see if adding BMS-986012 to the standard chemotherapy and OPDIVO can make the treatment more effective and safe for patients.
This is a Phase II study, which means the doctors are carefully watching for new information. They will be checking how patients feel, any side effects they experience, and how the cancer responds to the treatment. This helps them understand whether this new combination could be a good treatment option in the future.
Key takeaways
- It's a study for extensive-stage small cell lung cancer.
- Combines standard chemotherapy, OPDIVO, and a new drug (BMS-986012).
- Aims to check safety and how well the new combination works.
- You'll have regular hospital visits, treatments, and check-ups.
- Your health will be closely monitored for any side effects.
Who may be eligible?
To join this study, people generally need to be at least 18 years old. This study is specifically for individuals who have been diagnosed with extensive-stage small cell lung cancer. Both men and women can take part.
There will also be other specific health requirements that your hospital doctor will need to check. These might include having certain blood test results or not having other serious health conditions that could make the treatment unsafe for you. Your medical team will go through all these details with you carefully to see if this study is a good fit.
It's important to remember that joining a clinical trial is a big decision, and it’s only suitable for certain people who meet all the study’s specific requirements. Your doctor will discuss this with you in detail.
- Are you 18 years old or older?
- Have you been diagnosed with extensive-stage small cell lung cancer?
- Are you willing and able to attend regular hospital appointments?
- Are you able to take the study drugs as advised by the doctors?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, it would involve several visits to the hospital for treatment and check-ups. You would receive the study drugs (BMS-986012, OPDIVO, carboplatin, and etoposide) as infusions (given through a drip into your arm) over a period of time. You would also have regular scans, like PET scans, to see how the treatment is working on your cancer, and blood tests to monitor your health and check for any side effects.
Doctors and nurses would keep a very close eye on you throughout the study. They would ask you questions about how you are feeling and any symptoms you might have. The total length of your participation would depend on how your cancer responds to the treatment and what your doctor thinks is best for you, but there would also be follow-up appointments after your main treatment finishes.
Potential risks and benefits
Locations (7)
- —Romania
- —Spain
- —Belgium
- —Netherlands
- —Italy
- —Poland
- —Greece
Common questions
What is extensive-stage small cell lung cancer?
This is a type of lung cancer that has spread from where it started to other parts of the body.
What does 'Phase II' mean for a study?
It means the study is looking to see if the new treatment is safe and shows promise in helping patients, after having already completed earlier safety checks.
What are the treatments being tested?
It's a combination of four drugs: OPDIVO (Nivolumab), carboplatin, etoposide (these are common chemotherapy drugs), and a new study drug called BMS-986012.
Will I know if I'm getting the new drug?
This is an 'open label' study, which means both you and your doctors will know which treatments you are receiving.
What kind of tests will I have during the study?
You'll have regular scans (like PET scans) and blood tests to check on your health and how your cancer is responding to the treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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