Phase 1b/2a safety and tolerability study of bemcentinib with pembrolizumab/carboplatin/pemetrexed in subjects with untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without/with a STK11 mutation.
This research study is investigating new treatment options for a type of advanced lung cancer called non-small cell lung cancer that hasn't been treated before. We're testing a new medication, bemcentinib, alongside standard treatments: pembrolizumab (an immunotherapy) and carboplatin/pemetrexed (chemotherapy). The study is for people whose cancer is advanced or has spread, regardless of whether they have a specific gene change called an STK11 mutation. The main goals are to check if these new drug combinations are safe to use and how well they shrink or control the cancer over time. This is an early-stage study, meaning we're carefully monitoring participants for any side effects and looking at how their cancer responds to the new treatments.
At a glance
What is this study about?
This study is looking into new ways to treat a type of lung cancer called non-small cell lung cancer when it's advanced or has spread to other parts of the body and hasn't been treated before. We're particularly interested in whether a new drug, bemcentinib, can be safely and effectively combined with standard treatments that doctors already use. These standard treatments include pembrolizumab, which helps your body's immune system fight cancer, and two chemotherapy drugs, carboplatin and pemetrexed.
The study is divided into two main parts. The first part, called Phase 1b, focuses on safety. We'll be giving different doses of bemcentinib along with the other treatments to a small group of people. The main goal here is to carefully watch for any serious side effects during the first few weeks of treatment to find the safest dose. The second part, Phase 2a, will then look at how well these treatments work. We'll be checking to see if the combination of drugs shrinks the cancer or stops it from growing after 6 and 12 months. This includes people who may have a specific genetic change in their cancer, called an STK11 mutation, as well as those who don't.
Ultimately, the hope is to find better and safer treatment options for people living with this type of lung cancer. By understanding how these new combinations work and if they are tolerated well, we can potentially offer more effective therapies in the future.
Key takeaways
- This study explores new treatments for advanced non-small cell lung cancer.
- It combines a new drug (bemcentinib) with existing cancer treatments.
- The study includes people with or without a specific STK11 gene change.
- The main aims are to check safety and how well the treatment works.
- Participation involves regular clinic visits and health assessments.
Who may be eligible?
To join this study, you generally need to be an adult, 18 years old or older. The study is open to both men and women.
Your cancer needs to be a specific type called non-squamous non-small cell lung cancer that is advanced (meaning it has grown significantly) or metastatic (meaning it has spread to other parts of the body). It's also important that you haven't received any previous treatment for this advanced or metastatic lung cancer.
The study includes people with this type of lung cancer regardless of whether their cancer has a specific genetic change known as an STK11 mutation. This means if you have tested positive or negative for this mutation, you might still be able to take part.
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.
- Are you 18 years old or older?
- Have you been diagnosed with non-squamous non-small cell lung cancer that is advanced or has spread?
- Have you NOT received any previous treatment for your advanced or metastatic lung cancer?
- Are you willing to discuss your STK11 mutation status (if known) with the study team?
- Are you able to attend regular clinic visits for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you'll be given a combination of medications. This includes a new drug called bemcentinib, along with standard treatments: carboplatin, pemetrexed, and pembrolizumab. Bemcentinib might be given at different strengths (50mg, 75mg, or 100mg) depending on which part of the study you are in.
You will need to attend regular clinic visits. During these visits, doctors and nurses will check your health, take blood and urine samples, and carry out scans like CT scans to see how your cancer is responding. They will also ask you about any side effects you might be experiencing. These checks are very important, especially in the first few weeks, to make sure the treatment is safe for you. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will have regular follow-ups to monitor your progress and well-being.
Potential risks and benefits
Locations (6)
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedGreece
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedHungary
Common questions
What type of cancer is this study for?
This study is for a specific type of lung cancer called non-squamous non-small cell lung cancer, when it is advanced or has spread and hasn't been treated before.
What is an STK11 mutation?
An STK11 mutation is a specific change in a gene that can be found in some lung cancers. This study includes people with or without this mutation.
What drugs are being tested?
The study is testing a new drug called bemcentinib, in combination with standard treatments: pembrolizumab (an immunotherapy) and chemotherapy drugs carboplatin and pemetrexed.
What is the main goal of the study?
The main goals are to find out if the new drug combinations are safe and well-tolerated, and how well they help to shrink or control the cancer.
How long will I be in the study?
The length of your participation will depend on your individual response to the treatment, but you will have regular checks and follow-ups throughout.
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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