This study is being done in Non-Small Cell Lung Cancer, a common type of lung cancer that can spread to nearby tissues or other parts of the body. The study compares pumitamig, given by vein as BNT327, with pembrolizumab, also given by vein, as a first treatment for advanced disease with high PD-L1 levels, a protein found on some cancer cells. The purpose of the study is to see whether pumitamig can control cancer growth better and help people live longer than pembrolizumab.
People in the study are assigned to one of the two medicines. The treatment is given over time as intravenous infusions, which means medicine is put directly into a vein. The study is double-blind, which means the people taking part and the study doctors do not know which treatment is being given. During the study, doctors follow how the cancer changes, watch for side effects, and check how well each medicine is tolerated.
1<b>study treatment begins</b>
After you join the study, you start treatment for advanced non-small cell lung cancer, which is a type of lung cancer that has spread or is locally advanced.
You are assigned to receive either pumitamig or pembrolizumab. This study is double-blind, which means the treatment assignment is kept hidden during the study.
Pumitamig is given as an intravenous infusion, meaning it is delivered through a vein. The product is listed as BNT327 20 mg/ml or BNT327 50 mg/ml, and it is a concentrate for solution for infusion.
Pembrolizumab is also given by intravenous infusion.
The study is designed to compare pumitamig with pembrolizumab as the first treatment for this cancer.
2<b>ongoing treatment period</b>
You continue receiving the assigned study medicine during the treatment period.
The available source data does not state the exact dose, frequency, or duration for either medicine. It only states that both medicines are given by intravenous infusion.
The study follows how well the treatment controls the cancer, how long it takes before the cancer starts growing again, and how long people live.
The study also checks how safe each medicine is and how well people tolerate it.
3<b>assessment of treatment effect</b>
During the study, your cancer is checked with radiographic imaging, which means scans or pictures used to see whether the cancer is growing or shrinking.
One main measure is progression-free survival (PFS). This means the length of time before the cancer starts growing again.
Another main measure is overall survival (OS). This means the length of time people live during the study.
4<b>end of study follow-up</b>
The study continues until the planned end of the trial period.
The estimated study period runs from 2026-04-30 to 2031-10-26.
Who Can Join the Study?
Be an adult, meaning 18 years of age or older.
Have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC), meaning lung cancer that has spread or is at a later stage.
Have a documented PD-L1 level of 50% or higher. PD-L1 is a protein found on some cancer cells, and the result must be recorded in medical testing.
Be in good overall health, meaning healthy enough to take part in the study treatment.
Have not received prior systemic anti-cancer therapy for advanced NSCLC. Systemic therapy means treatment that travels through the whole body, such as medicine given by vein or taken by mouth, and anti-cancer therapy means treatment intended to treat cancer.
Who Cannot Join the Study?
Documented gene changes in the cancer with already approved treatments: people whose cancer has known gene changes for which there are already approved medicines cannot join.
Untreated brain metastases: people with cancer that has spread to the brain and has not yet been treated cannot join. Metastases means cancer that has spread from its original place to another part of the body.
Significant cardiovascular disease: people with serious heart or blood vessel disease cannot join. Cardiovascular means related to the heart and blood vessels.
Active autoimmune disease: people with an ongoing disease in which the immune system attacks the body’s own tissues cannot join. Autoimmune means the immune system attacks the body by mistake.
Serious lung disease: people with severe lung problems cannot join.
High risk of pulmonary bleeding: people who are at high risk of bleeding in the lungs cannot join. Pulmonary means related to the lungs.
Abdominal fistula within 6 months before randomization: people who had an abnormal opening between organs or tissues in the belly area in the past 6 months cannot join. A fistula is an unusual tunnel that should not be there.
Gastrointestinal perforation within 6 months before randomization: people who had a hole in the stomach or intestines in the past 6 months cannot join. Gastrointestinal means the stomach and intestines. Perforation means a hole or tear.
Pumitamig is the study drug being tested in this trial. It is given through a vein as an infusion. The trial is looking at whether pumitamig can control the cancer better and help people live longer than the comparison treatment. It is being used as a single treatment in this study.
Pembrolizumab is the comparison treatment in this trial. It is also given through a vein as an infusion. Researchers are comparing it with pumitamig to see which treatment works better for people with this type of lung cancer.
Non-Small Cell Lung Cancer – A group of lung cancers that start in the cells lining the airways or air sacs of the lung. It usually grows and spreads more slowly than small cell lung cancer, but it can still enlarge in the lung, spread to nearby lymph nodes, and later spread to other parts of the body.
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