The immune system plays an important role in fighting tumors. Pembrolizumab (MK-3475) is an antibody that prevents the tumor from suppressing the immune system. The aim is to demonstrate the extent to which the use of pembrolizumab is beneficial as an additional therapy to standard therapy (radiotherapy of the tumor).
Aim of the study
The study investigates the standard treatment for non-resected non-small cell lung cancer with or without pembrolizumab. We are doing this study to determine whether pembrolizu-mab (MK-3475) together with standard treatment (stereotactic radiotherapy, SBRT) is safe and whether it can delay the recurrence of non-small cell lung cancer (NSCLC) more effectively than placebo (a look-alike product but without the active ingredient) with SBRT. SBRT is a procedure in which radiation is used precisely at the site of the tumor to destroy cancer cells.
Who can take part?
Participants with unresected stage I or II non-small cell lung cancer (NSCLC)
Procedure
In the course of the study, medical data, blood samples, urine samples (etc.) are recorded or taken. You will be asked to come to the test center approximately every 3 weeks for the study treatment and more frequently in the first cycle for the SBRT. During your study visits, you will be physically examined, your vital signs will be checked and an electrocardiogram (ECG) may be performed. Your disease status and any side effects you have had will also be checked. At the beginning of the study, positron emission tomography (PET) and computer tomography (CT) or magnetic resonance imaging (MRI) are also carried out. During the course of the study, CT scans or MRIs of your tumor will be performed every 12 to 16 weeks.
Compensation
None
Original study name
A randomized, placebo-controlled phase 3 clinical trial to evaluate the safety and efficacy of stereotactic body radiotherapy (SBRT) with or without pembrolizumab (MK-3475) in participants with medically inoperable stage I or IIA non-small cell lung cancer (NSCLC)
BASEC number
2019-00574
Financial support from
Merck Sharp & Dohme