Phase III clinical trial - Appareil pulmonaire

AMG 20190009_25004
Appareil pulmonaire
Essai clinique fermé
Public cible
A Phase 3 Multicenter, Randomized, Open;Label, Active-controlled, Study of AMG 510;Versus Docetaxel for the Treatment of Previously;Treated Locally Advanced and Unresectable or;Metastatic NSCLC Subjects With Mutated;KRAS p.G12C
Description de l'essai
This is a phase 3, multicenter, randomized, open label, active-controlled, study to;evaluate the efficacy, safety, and tolerability of AMG 510 versus docetaxel in subjects;with previously treated locally advanced and unresectable or metastatic NSCLC with;KRAS p.G12C mutation. The study will be conducted at approximately 300 sites;globally. The study will consist of a screening period, a treatment period and long-term;follow-up period. Approximately 650 previously treated subjects with locally advanced;and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation;will be enrolled and randomized 1:1 to receive either AMG 510 or docetaxel.