A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Investigational Agents in Combination with Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)
This research is a Phase 2 study for people with extensive-stage small cell lung cancer who are starting treatment for the first time. Doctors are testing a combination of Pembrolizumab with various other new medications, including Lenvatinib and MK-4830, alongside standard chemotherapy (Etoposide with either Cisplatin or Carboplatin). The main goals are to see how much the tumours shrink (Objective Response Rate) and how long people live without their cancer getting worse (Progression-Free Survival) over six months. We also want to understand if these new combinations are safe and how they affect patients' quality of life.
At a glance
What is this study about?
This study, called KEYNOTE-B99, is looking into new treatment options for people with a type of lung cancer called extensive-stage small cell lung cancer. 'Extensive-stage' means the cancer has spread quite widely within the body. This particular study is for people who are just starting their cancer treatment for the first time.
The main idea behind the study is to combine an existing medication called Pembrolizumab with other newer investigational drugs, such as Lenvatinib and MK-4830. These new combinations will be given alongside standard chemotherapy, which typically involves Etoposide paired with either Cisplatin or Carboplatin. By trying these new combinations, doctors hope to find more effective ways to fight this type of cancer.
Researchers will carefully watch how well these new combinations work. They will measure if tumours shrink and how long people stay well without their cancer growing. They will also pay close attention to any side effects to make sure the treatments are as safe as possible. Understanding how these new treatments affect a person's daily life and general well-being is also a very important part of the study.
Key takeaways
- This study is for advanced small cell lung cancer that is being treated for the first time.
- It combines existing immunotherapy with new drugs and standard chemotherapy.
- The aim is to find more effective and safe ways to treat this type of cancer.
- Researchers will monitor tumour shrinkage, how long people stay well, and side effects.
- It's a Phase 2 study, meaning it's checking for safety and early signs of effectiveness.
Who may be eligible?
To be part of this study, you need to be at least 18 years old. Both men and women can take part.
You must have extensive-stage small cell lung cancer, and this must be your very first time receiving treatment for it. More specific health checks will be done by the study doctors to make sure the treatment is suitable for you.
- Are you 18 years old or older?
- Do you have extensive-stage small cell lung cancer?
- Has this cancer not been treated before?
- Are you able to attend regular clinic appointments for treatment and check-ups?
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'll be given a combination of medications, which will include Pembrolizumab, other investigational drugs like Lenvatinib or MK-4830, and chemotherapy (Etoposide with either Cisplatin or Carboplatin). These medications are typically given as infusions into a vein. You would have regular visits to the clinic for your treatments and to have check-ups. During these visits, doctors and nurses will monitor your health, check for any side effects, and carry out tests like scans to see how the treatment is affecting your cancer. The total length of your participation would depend on how your treatment progresses.
Potential risks and benefits
Locations (5)
- —Poland
- —Hungary
- —Spain
- —Italy
- —Austria
Common questions
What does 'extensive-stage small cell lung cancer' mean?
It means the lung cancer has spread beyond the lung where it started to other parts of the body.
What is Pembrolizumab?
Pembrolizumab is a type of immunotherapy that helps your body's immune system fight cancer cells.
What are 'investigational agents'?
These are new medications, like Lenvatinib and MK-4830, that are still being tested to see if they are safe and effective.
What is a 'Phase 2 study'?
A Phase 2 study checks if a new treatment is safe and if it shows encouraging signs of working, usually in a larger group of people than a Phase 1 study.
Will I definitely get the new drugs?
Yes, in this study, all participants will receive the combination of Pembrolizumab, other investigational drugs, and standard chemotherapy.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.