GO41717: A Phase III, randomized, double-blinded, place-bo-controlled study of Tiragolumab, an Anti-Tigit Antibody, in combination with Atezolizumab compared with placebo in combination with Atezolizumab in patients with previously untreated locally advanced unresectable or metastatic PD-L1 selected Non-Small Cell Lung Cancer

Projekt

Geplant · 2020 bis 2024

Art

Klinische Forschung

Reichweite

Multizentrisch, KSSG als teilnehmendes Zentrum

Status

Geplant

Start

2020

Ende

2024

Finanzierungsart

Industrie

Studiendesign

Phase III

Schlagwörter (Tags)

Tiragolumab, an Anti-Tigit Antibody, combination with Ate-zolizumab, previously untreated locally advanced unresec-table or metastatic PD-L1 selected, Non-Small Cell Lung Cancer

Kurzbeschreibung/Zielsetzung

This study will evaluate the efficacy and safety of ti-ragolumab plus atezolizumab compared with placebo plus atezolizumab in patients with previously untreated locally advanced, unresectable or metastatic programmed deathligand 1 (PD-L1)selected nonsmall cell lung can-cer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The primary population is defined as all ran-domized patients who are selected on the basis of a mini-mum level of PD-L1 expression (tumor proportion score [TPS]  50%) by central testing using the PD-L1 immuno-histochemistry (IHC) 22C3 pharmDx assay. In this proto-col, "study treatment" refers to the combination of treat-ments assigned to patients as part of this study (i.e., ti-ragolumab plus atezolizumab and placebo plus atezoli-zumab).