Phase II clinical trial - Appareil pulmonaire

LUMINOSITY (M14-239)
Appareil pulmonaire
Essai clinique fermé
Public cible
Adulte
Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer
Description de l'essai
This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2).;Telisotuzumab vedotin (ABBV-399) is an antiÀc-Met antibody drug;conjugate (ADC) for the treatment of c-MetÀoverexpressing solid;tumors. The pharmacology, toxicology, and pharmacokinetic profiles;of telisotuzumab vedotin were adequately characterized to support;initiation of a Phase 2 clinical trial in subjects with locally advanced or;metastatic non-small cell lung cancer (NSCLC). The non-clinical and;clinical data together reflect an acceptable rationale for continued;treatment of adult subjects with advanced cancer with telisotuzumab;vedotin within the context of a clinical trial.
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NICOLAS GIRARD
Investigateur principal