Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
This research study is looking at a new treatment called pumitamig, given along with standard chemotherapy and other existing drugs, for people with non-small cell lung cancer who are starting their first treatment. It's a large study, happening at many different hospitals. The main goal is to find out if this new drug combination is safe and effective in treating this type of lung cancer. The study is divided into two main parts, Phase 2 and Phase 3, which helps researchers carefully test the new drug step-by-step. Participants will be grouped based on their specific type of lung cancer, as treatment plans can vary. Your health will be closely monitored throughout the study.
At a glance
What is this study about?
This research study is focused on people who have a type of lung cancer called non-small cell lung cancer (NSCLC). Doctors are investigating a new treatment that combines a drug called pumitamig (also known as BNT327) with standard chemotherapy drugs like Carboplatin, Pemetrexed, or Paclitaxel, and sometimes another drug called Pembrolizumab. The main aim is to see how safe this new combination is and how well it works in treating NSCLC in patients who are receiving their first treatment for this cancer.
The study is split into two phases: Phase 2 and Phase 3. Phase 2 tries to find the best dose and check for safety in a smaller group of people. If that goes well, Phase 3 will involve more people to confirm the safety and effectiveness compared to existing treatments. This two-step approach helps ensure that new treatments are thoroughly tested before they become widely available. The study is also designed to look at different types of NSCLC within two substudies, as the best chemotherapy can vary depending on the specific kind of cancer.
Throughout the study, experts will regularly review the information gathered to ensure everything is progressing safely and correctly. This includes looking at your scans to see how the treatment is affecting the cancer. Taking part means you'd be contributing to valuable research that could help future patients with non-small cell lung cancer. The total time you might be involved in the study could be up to 64 months.
Key takeaways
- The study is for advanced non-small cell lung cancer (NSCLC).
- It tests a new drug, pumitamig, combined with usual chemotherapy.
- It aims to find out if the new combination is safe and effective.
- Participation could last up to 64 months.
- You'll have regular medical checks and scans.
Who may be eligible?
To join this study, you would need to have been diagnosed with a specific type of non-small cell lung cancer (NSCLC) that has either spread locally or to other parts of the body, and for which surgery or radiation is not a cure. You should not have received any previous treatment for this cancer, such as chemotherapy or certain other cancer drugs. Your cancer also needs to show up on scans so that doctors can measure how well the treatment is working.
There are also some general health requirements. For example, your organs (like your liver and kidneys) need to be working well, and your overall physical condition should be good enough to participate in a clinical trial. There are specific health details your study doctor will check.
However, some people would not be able to join. This includes if your lung cancer is a different type (like small-cell lung cancer), or if you've already had certain treatments for your lung cancer. You also couldn't join if you have uncontrolled high blood pressure or are taking high doses of certain steroid medications shortly before the study starts. Your doctor will go through all the detailed criteria with you.
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 advanced or metastatic non-small cell lung cancer?
- Have I received no previous treatment for my lung cancer?
- Is my general health good enough for a clinical trial?
- Do I have cancer that can be measured on a scan?
- Do I have good organ function (e.g., kidneys, liver)?
What does participation involve?
If you decide to take part in this study, your journey could last up to 64 months, which is about 5 years and 4 months. You would be assigned by chance (like flipping a coin) to receive one of the study treatments, which will include the new drug pumitamig along with standard chemotherapy and potentially other medicines. You will visit the study site regularly for your treatments and to have your health checked.
These check-ups will involve things like blood tests, physical examinations, and scans (such as CT scans) to see how your cancer is responding and to monitor for any side effects. An independent group of experts will review your scans to ensure accuracy. The doctors and nurses will explain each visit and what to expect in detail, making sure you understand everything that's involved.
Potential risks and benefits
Locations (225)
- Alaska Oncology and Hematology, LLCVerified postcodeAnchorage, United States· Recruiting
- John Muir Clinical Research CenterVerified postcodeConcord, United States· Recruiting
- University Of California - San Diego Moores Cancer CenterVerified postcodeLa Jolla, United States· Recruiting
- Clermont Oncology CenterVerified postcodeClermont, United States· Recruiting
- Mid Florida Cancer CentersVerified postcodeOrange City, United States· Recruiting
- Cleveland Clinic Florida - Martin North HospitalVerified postcodeStuart, United States· Recruiting
- H. Lee Moffit Cancer center and research instituteVerified postcodeTampa, United States· Recruiting
- Cleveland Clinic Weston HospitalVerified postcodeWeston, United States· Recruiting
- Fort Wayne Medical Oncology and Hematology, Inc.Verified postcodeFort Wayne, United States· Recruiting
- Physicians Clinic of IowaVerified postcodeCedar Rapids, United States· Recruiting
- Holden Comprehensive Cancer Center, University of Iowa Hospitals and ClinicsVerified postcodeIowa City, United States· Recruiting
- Baptist Health HardinVerified postcodeElizabethtown, United States· Recruiting
Common questions
What kind of lung cancer is this study for?
This study is specifically for people with non-small cell lung cancer (NSCLC) that is advanced or has spread, and where surgery or radiation isn't a cure.
What is 'pumitamig'?
Pumitamig is an experimental drug being tested in this study. It's given alongside standard chemotherapy and other available treatments for lung cancer.
Will I definitely get the new drug?
Yes, all participants in this study will receive the new drug pumitamig, combined with other standard treatments, but at different dose levels.
How long will I be in the study if I join?
The study could last for up to 64 months, which is about 5 years and 4 months, though the time you personally spend might be shorter.
What does 'Phase 2/3' mean?
This means the study is in a stage where it's looking closely at the best dose and safety (Phase 2), and then expanding to a larger group to confirm if it works well compared to existing treatments (Phase 3).
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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