A Phase II Study of Atezolizumab with Bevacizumab for Patients with PD-L1 High Expression Non-Small Cell Non-Squamous Cell Lung Cancer (WJOG10718L Investigator-Initiated Clinical Trial)

Takashi Seto (Coordinating Investigator)0 sites38 target enrollmentJuly 18, 2018

Overview

No summary available.

Registry

who.int

Start Date

July 18, 2018

End Date

January 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Takashi Seto (Coordinating Investigator)

•1\. Patients with a histologically confirmed diagnosis of non\-squamous NSCLC
•2\. Patients with the high PD\-L1 expression (TPS\>\=50%, Dako 22C3 antibody) in tumor tissue by immunohistochemistry using archived tumor tissue samples collected in the past or tissue samples taken by a biopsy at screening
•3\. Patients who are confirmed to be negative for EGFR mutation, ALK gene translocation and ROS1 gene translocation
•4\. Patients with stage III and stage IV NSCLC not treatable with radical radiotherapy or postoperative recurrent NSCLC
•5\. Patients with measurable disease as defined by the RECIST version 1\.1
•6\. Absence of brain metastasis that is symptomatic or requires antiedematous agents such as steroid or anticonvulsants for controlling symptoms
•7\. Patients who were not previously treated with both chemotherapy and radiotherapy including treatment for other cancer types
•8\. ECOG PS 0 or 1

•1\. Patients with active other cancers except for NSCLC
•2\. Patients with a past or current history of hemoptysis
•3\. Presence of a bleeding tendency
•4\. Patients with a past or current history of interstitial lung disease evident on CT scans, drug\-induced lung disorder and pneumonitis requiring steroid treatment
•5\. Hypertension uncontrollable with standard drug therapy
•6\. Patients with a history of serious hypersensitivity or with hypersensitivity to the ingredients or additives of atezolizumab and bevacizumab
•7\. Pregnant women, lactating women, women who may be pregnant at present or patients not intending to practice contraception