Phase III clinical trial - Appareil pulmonaire

TROPION-Lung01 (DS1062-A-U301)
Appareil pulmonaire
Ouvert depuis le: 09.22.2021
Site: Paris
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PHASE 3 RANDOMIZED STUDY OF DS-1062A VERSUS;DOCETAXEL IN PREVIOUSLY TREATED ADVANCED;OR METASTATIC NON-SMALL CELL LUNG CANCER;WITHOUT ACTIONABLE GENOMIC ALTERATIONS;(TROPION-LUNG01)
Description de l'essai

This is a global, multicenter, randomized, active-controlled, open-label Phase 3 study designed to evaluate the;efficacy, safety, and pharmacokinetics (PK) of DS-1062a versus docetaxel in subjects with advanced or;metastatic NSCLC without actionable genomic alterations (ie, alterations in genes with approved therapies, such;as EGFR, ALK, ROS1, NTRK, BRAF, or other actionable driver oncogenes) and who have been previously;treated with platinum-based chemotherapy and a-PD-1/a-PD-L1 monoclonal antibody, either in combination or;sequentially. Patients who received a-PD-1/a-PD-L1 monoclonal antibody as frontline therapy may have;received the combination of platinum-based chemotherapy and a-PD-1/a-PD-L1 monoclonal antibody in the;second line setting.