Clinical trial of cemiplimab with BNT116 compared to cemiplimab as first-line treatment in patients with non-small cell lung cancer

THE STUDY IS INVESTIGATING AN INVESTIGATIONAL DRUG CALLED BNT116 THAT IS INITIALLY GIVEN ALONE AND THEN COMBINED WITH CEMIPLIMAB (IN THIS DOCUMENT, BOTH BNT116 AND CEMIPLIMAB WILL BE REFERRED TO AS A "STUDY DRUG" AND TOGETHER AS THE "STUDY DRUGS"). THE STUDY FOCUSES ON PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC). THE PURPOSE OF THE STUDY IS TO EVALUATE THE SAFETY AND TOLERABILITY OF TNB116 IN MONOTHERAPY AND IN COMBINATION WITH CEMIPLIMAB, AS WELL AS THE EFFICACY OF TNB116 IN COMBINATION WITH CEMIPLIMAB COMPARED TO CEMIPLIMAB IN MONOTHERAPY IN TREATING THEIR CANCER. THE STUDY ALSO EXAMINES OTHER SCIENTIFIC QUESTIONS, SUCH AS: . WHAT SIDE EFFECTS MAY OCCUR FROM RECEIVING THE STUDY DRUGS. . EXPLORATORY INVESTIGATIONS TO LEARN MORE ABOUT THE STUDY DRUGS AND THEIR EFFECTS ON NSCLC . . DETERMINING THE CONCENTRATION OF THE STUDY DRUG IN YOUR BLOOD AT DIFFERENT TIMES . . FINDING OUT IF YOUR BODY MAKES ANTIBODIES AGAINST THE STUDY DRUG (WHICH COULD REDUCE THE EFFECTIVENESS OF THE DRUG OR CAUSE SIDE EFFECTS).