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Clinical trial of Debio 1143 in combination with platinum derivative chemotherapy and radiotherapy in patients with locally advanced head and neck squamous cell carcinoma suitable for definitive chemoradiotherapy.
THE MAIN OBJECTIVE OF THIS STUDY IS TO FIND OUT HOW WELL DEBIO 1143 WORKS AND HOW SAFE IT IS COMPARED TO A PLACEBO. A PLACEBO IS AN INACTIVE SUBSTANCE THAT LOOKS LIKE THE STUDY DRUG, BUT DOES NOT CONTAIN ANY ACTIVE DRUG. RESEARCHERS USE A PLACEBO TO SEE IF THE STUDY DRUG WORKS BETTER OR IF IT IS AS SAFE AS TAKING NOTHING.
- PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF DEBIO 1143 IN COMBINATION WITH PLATINUM DERIVATIVE CHEMOTHERAPY AND CONVENTIONAL FRACTIONATION INTENSITY-MODULATED RADIOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA SUITABLE FOR DEFINITIVE CHEMORADIOTHERAPY (TRILYNX).
- Code EudraCT: 2020-000377-25
- Protocol number: Debio 1143-SCCHN-301
- Promoter: Debiopharm International S.A.
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