A Phase 1/2 Randomized Trial of BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive-Stage Small Cell Lung Cancer
This research study is lookin into a new medicine, BMS-986012, for adults with extensive-stage small cell lung cancer. This particular type of lung cancer has spread widely in the body. The study combines BMS-986012 with a common treatment (platinum and etoposide) that many people with this cancer already receive as their first treatment. This is an early-stage study (Phase 1 and 2), meaning the researchers are primarily checking the safety of the new combination. They also want to get a first idea of how well it might work and how the body handles the new medicine. Participants will be closely monitored for any side effects and to see if the treatment helps slow down the cancer's growth.
At a glance
What is this study about?
This study is about finding new ways to treat a type of lung cancer called extensive-stage small cell lung cancer. 'Extensive-stage' means the cancer has spread quite a bit in the body already. For people with this cancer, doctors often suggest a standard treatment that includes medicines called platinum and etoposide. This study is testing if adding a new medicine, called BMS-986012, to this standard treatment could be helpful.
The main goals of this study are to see how safe the combination of the new medicine and the standard treatment is. Researchers will carefully watch for any side effects or problems that people might experience. They will also look at how the new medicine works in the body and if it helps to control the cancer's growth. This kind of study, called a Phase 1/2 study, is often one of the first steps in testing new medicines in people, focusing on safety first and then getting an early look at how effective it might be.
Learning more about treating extensive-stage small cell lung cancer is very important because it can be challenging to treat. By exploring new combinations of medicines, doctors hope to find better ways to help people with this condition. The information gathered from this study will help decide if this new treatment combination should be studied in more detail in the future.
Key takeaways
- This study is for people with extensive-stage small cell lung cancer.
- It tests a new medicine (BMS-986012) with standard chemotherapy.
- The main goals are to check safety and how well the treatment works.
- Participants will have regular check-ups and tests.
- It's an early-stage study (Phase 1/2) for a new treatment combination.
Who may be eligible?
To be able to join this study, participants generally need to be adults, at least 18 years old. Both men and women can take part.
Because this study is for 'extensive-stage small cell lung cancer,' participants must have been diagnosed with this specific type of cancer that has spread.
There might be other health conditions or previous treatments that could affect whether someone can join. For instance, sometimes certain medications you're already taking or other health issues might mean the study treatment isn't suitable for you. Your doctor will carefully review your full medical history to see if this study is a good fit for you.
- Are you 18 years old or older?
- Have you been diagnosed with extensive-stage small cell lung cancer?
- Have you not yet received treatment for your extensive-stage small cell lung cancer?
- Are you able to attend regular clinic visits and appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will receive the new medicine (BMS-986012) along with the standard chemotherapy (platinum and etoposide). You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These tests will help the doctors understand if the treatment is safe and if it is helping your cancer. We do not have specific details about the frequency of visits or the total length of the study from the information provided, but you should expect regular appointments for treatment and monitoring over several months. There will also be follow-up appointments after your treatment has finished to see how you are doing in the long term.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is 'extensive-stage small cell lung cancer'?
It's a type of lung cancer where the disease has spread from the lung to other parts of the body.
What kind of new medicine is BMS-986012?
It's an investigational medicine being tested to see if it can improve treatment outcomes when added to standard chemotherapy.
What does Phase 1/2 mean?
It means this is an early stage of testing. Phase 1 mainly checks safety and dosage, and Phase 2 looks more at how well the treatment works and any side effects.
Will I definitely get the new medicine?
Yes, in this study, all participants will receive the new medicine (BMS-986012) along with the standard treatment.
What are the main things researchers are looking for?
They are mainly checking for side effects and how safe the treatment is, but also beginning to see if it helps patients live longer without their cancer getting worse.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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