Phase I/II clinical trial - Appareil pulmonaire

BP40657
Appareil pulmonaire
Ouvert depuis le: 06.16.2019
Site: Paris
Public cible
Adulte
A TWO-PART PHASE Ib/II STUDY TO INVESTIGATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF ATEZOLIZUMAB SUBCUTANEOUS IN PATIENTS WITH STAGE IV;NONÀSMALL CELL LUNG CANCER
Description de l'essai

This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) in patients with Non-Small Cell Lung Cancer (NSCLC). A dose-finding part (Part 1) will aim to identify the dose of atezolizumab SC that yields drug exposure that is comparable to that of atezolizumab IV. A dose-confirmation part (Part 2) will aim to demonstrate the non inferiority of observed drug exposure following treatment with atezolizumab SC at the identified dose compared with historical drug exposure following treatment with atezolizumab IV.