This clinical trial is focused on studying the treatment of non-small cell lung cancer, a common type of lung cancer. The study will explore the use of an investigational therapy called BNT327 in combination with chemotherapy and other investigational agents. Chemotherapy involves using drugs to kill cancer cells, and in this study, the drugs include paclitaxel, pembrolizumab (also known as Keytruda), pemetrexed, and carboplatin. These medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.
The purpose of the study is to evaluate the safety and effectiveness of BNT327 when used with chemotherapy. The trial is divided into two phases: Phase II and Phase III. In Phase II, the focus is on assessing how safe and tolerable BNT327 is at different dose levels when combined with chemotherapy. In Phase III, the study will compare the effectiveness of BNT327 combined with chemotherapy to the combination of pembrolizumab and chemotherapy. The study will also look at how these treatments affect the progression of the disease and overall survival of participants.
Participants in the study will receive treatment over a period of time, with regular follow-up visits to monitor their health and the effects of the treatment. The study aims to provide valuable information on the potential benefits and risks of using BNT327 in treating non-small cell lung cancer, which could lead to new treatment options for patients in the future.
1initial visit
Upon joining the clinical trial, you will attend an initial visit. During this visit, medical staff will review your medical history and perform a physical examination to ensure you meet the trial’s eligibility criteria.
You will be informed about the trial procedures, potential risks, and benefits. You will be asked to provide written consent to participate in the study.
2screening tests
You will undergo various screening tests to confirm your eligibility. These tests may include blood tests, imaging scans, and other assessments to evaluate your overall health and the status of your lung cancer.
3treatment phase
If eligible, you will begin the treatment phase. This involves receiving the investigational therapy BNT327 in combination with chemotherapy drugs such as paclitaxel, pembrolizumab, pemetrexed, and carboplatin.
These medications are administered as a solution for infusion, which means they are given directly into your bloodstream through a vein. The specific dosage and frequency will be determined by the study protocol and your healthcare team.
4regular follow-up visits
Throughout the trial, you will have regular follow-up visits. During these visits, medical staff will monitor your health, assess the effectiveness of the treatment, and check for any side effects.
You may be required to undergo additional tests and assessments to track your progress and ensure your safety.
5end of treatment
Once the treatment phase is complete, you will have a final assessment to evaluate the overall impact of the therapy on your lung cancer.
You will be informed about any further steps or follow-up care that may be necessary after the trial concludes.
690-day follow-up
After completing the treatment, there will be a 90-day follow-up period. During this time, you will continue to be monitored for any long-term effects or changes in your health status.
This follow-up is crucial to ensure your well-being and to gather additional data on the investigational therapy’s safety and effectiveness.
Who Can Join the Study?
Are able to give informed consent and have given written consent. This means you understand the study and agree to participate.
Are a person of child-bearing potential (POCBP) who agrees to use a highly effective form of birth control and require their male partners to use barrier methods like condoms, starting from the screening visit until 6 months after the last dose of the study drug.
Are men who are sterile or, if potentially fertile and sexually active with a partner who can have children, agree to use condoms and ask their partners to use a highly effective form of birth control during the study, starting from giving consent until 6 months after the last dose of the study drug.
Agree not to donate or freeze sperm or eggs for assisted reproduction during the study, starting at screening and until 6 months after the last dose of the study drug.
Are willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and assessments. This means you can understand and follow the study instructions.
Are male or female, aged 18 years or older at the time of giving consent.
Have a confirmed diagnosis of Stage IIIB or IIIC non-small cell lung cancer that cannot be treated with surgery or radiotherapy, or Stage IV non-small cell lung cancer without specific genetic mutations (EGFR or ALK).
Have at least one measurable tumor based on specific medical criteria (RECIST v1.1).
Have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
Have a life expectancy of more than 3 months.
Have adequate organ function, meaning your blood, liver, kidneys, and blood clotting are working well enough for the study.
Are a person of child-bearing potential who has a negative pregnancy test at screening and before each dose of the study drug.
Who Cannot Join the Study?
Patients with any other type of cancer besides non-small cell lung cancer cannot participate.
Patients who have had a different cancer treatment within the last 4 weeks are not eligible.
Patients with severe heart problems, such as heart failure or a recent heart attack, cannot join the study.
Patients with uncontrolled high blood pressure are excluded.
Patients with active infections, such as untreated bacterial or viral infections, cannot participate.
Patients who are pregnant or breastfeeding are not eligible.
Patients with known allergies to the study drugs or similar drugs cannot join.
Patients with a history of severe allergic reactions to any medication are excluded.
Patients with significant liver or kidney disease cannot participate.
Patients who have participated in another clinical trial within the last 30 days are not eligible.
BNT327 is an investigational medication being studied for its potential use in treating non-small cell lung cancer. In this clinical trial, it is being tested in combination with chemotherapy to see how well it works and how safe it is for patients. The trial aims to find out if this new medication can help improve the treatment outcomes for patients with this type of lung cancer.
Pembrolizumab is a medication that is already used in the treatment of various types of cancer, including non-small cell lung cancer. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, pembrolizumab is being used in combination with chemotherapy to compare its effectiveness against the new investigational medication, BNT327, also combined with chemotherapy. The goal is to determine which treatment option provides better results for patients.
Non-small cell lung cancer – Non-small cell lung cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease often progresses slowly, with symptoms that may include a persistent cough, chest pain, and shortness of breath. As it advances, it can lead to more severe respiratory issues and may affect other organs. The progression of the disease can vary depending on the subtype and individual patient factors.
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