Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
This research study is testing a new treatment called BNT116 for people with advanced non-small cell lung cancer (NSCLC). It's a 'first-in-human' study, meaning it's one of the first times BNT116 is being given to people. The main goals are to find out if BNT116 is safe, what the right dose is, and how well it works. Researchers are studying BNT116 by itself and in combination with other approved and experimental cancer medicines, such as cemiplimab, docetaxel, and some new experimental drugs. The study includes people with different stages of NSCLC, including those with advanced or metastatic disease, as well as some with earlier stages. It also looks at specific types like those with EGFR, ALK, or RET gene changes.
At a glance
What is this study about?
This study is particularly for people who have been diagnosed with non-small cell lung cancer (NSCLC), which is the most common type of lung cancer. The researchers are interested in a new treatment called BNT116. This is an early-stage study, meaning it's one of the first times this new treatment is being tested in people. The main aim is to carefully check if BNT116 is safe and tolerable, which means seeing how people feel while taking it and if there are any side effects. They also want to find the best dose to give people.
Beyond safety, the study is also looking into whether BNT116 can help treat NSCLC. They are testing it in different ways: sometimes BNT116 will be given on its own, and sometimes it will be combined with other cancer treatments that are already approved, or with other new treatments still being researched. This helps them understand if BNT116 works better with other drugs or by itself. They are studying people with various stages of NSCLC, including those where the cancer has spread (advanced or metastatic), as well as some at earlier stages, and even specific types of NSCLC linked to certain gene changes.
Different groups (called 'cohorts') within the study will receive different combinations of treatments. For example, some may receive BNT116 with established chemotherapy drugs like docetaxel, carboplatin, or paclitaxel, while others might get it with newer targeted therapies or immune system-boosting drugs. The overall goal is to gather important information about this potential new treatment to see if it could be a helpful option for people with non-small cell lung cancer in the future.
Key takeaways
- This study is for people with non-small cell lung cancer (NSCLC).
- It's testing a new drug, BNT116, for safety and how well it works.
- BNT116 will be tested alone and in combinations with other cancer treatments.
- The study includes people with various stages and types of NSCLC.
- Participation length varies, generally up to 1-2 years.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, everyone must have non-small cell lung cancer that has been confirmed by a doctor. Generally, your cancer needs to be advanced or have spread, and doctors need to be able to measure it. However, some specific groups in the study don't need to have measurable cancer.
Your general health also matters. You should be in good enough health to participate, generally able to carry out most daily activities without too much difficulty. If you've previously had certain immune-boosting treatments, you must have been able to tolerate them without having to stop permanently due to side effects. Some parts of the study are only for people with specific gene changes in their cancer, and these particular groups are only looking for volunteers in the US.
Finally, the study has different groups depending on your specific lung cancer stage and previous treatments. For example, some groups are for people who have already had certain types of chemotherapy and immune-boosting drugs, while others are for those with resectable (removable by surgery) lung cancer.
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.
- Do I have non-small cell lung cancer?
- Is my general health good enough to participate?
- Have I been able to tolerate prior anti-PD-1/PD-L1 treatments if I've had them, without having to stop permanently?
- Am I aware that some parts of the study are only for certain gene changes or stages of cancer?
What does participation involve?
If you join this study, the total time you'll be on treatment can vary. For most people, it will be up to 24 months (2 years). However, for some specific groups, it might be 18 months, or even shorter, such as 12 months for others. One group undergoing surgery will have a short course of treatment before surgery and then another course of treatment for 12 months after surgery.
Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. The study involves taking the investigational drug BNT116, either alone or with other medications, as decided by your study doctor based on your specific group. The doctors will closely monitor your health and progress at each visit. The exact schedule of visits and tests will be explained to you in detail by the study team.
Potential risks and benefits
Locations (44)
- University of Kentucky Chandler Medical CenterVerified postcodeLexington, United States· Recruiting
- Norton Cancer InstituteVerified postcodeLouisville, United States· Recruiting
- Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterVerified postcodeBaltimore, United States· Recruiting
- MD Anderson Cancer CenterVerified postcodeHouston, United States· Recruiting
- NEXT VirginiaVerified postcodeFairfax, United States· Recruiting
- Scientia Clinical ResearchVerified postcodeRandwick, Australia· Recruiting
- Royal North Shore HospitalVerified postcodeSydney, Australia· Recruiting
- Cancer Research SAVerified postcodeAdelaide, Australia· Recruiting
- Monash HealthVerified postcodeClayton, Australia· Recruiting
- Universitätsklinikum KölnVerified postcodeCologne, Germany· Recruiting
- Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)Verified postcodeFrankfurt, Germany· Recruiting
- University Medical Center Hamburg-EppendorfVerified postcodeHamburg, Germany· Recruiting
Common questions
What is Non-Small Cell Lung Cancer (NSCLC)?
NSCLC is the most common type of lung cancer. This study is for people with different stages of this specific type of lung cancer.
What does 'first-in-human' mean?
It means this is one of the first times this new drug, BNT116, is being given to people. Researchers are carefully watching for safety and how it affects the body.
Will I get BNT116 by itself or with other drugs?
It depends on which group you're in. Some groups will get BNT116 alone, while others will get it combined with other cancer medicines, some approved and some experimental.
How long will I be in the study?
This varies, but generally, it can be up to 24 months (2 years) for most groups, or sometimes 12 to 18 months for others, depending on your treatment plan.
Can I leave the study if I want to?
Yes, you can choose to leave the study at any time, for any reason. Your future medical care will not be affected.
How to find out more
BioNTech clinical trials patient information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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