Appendix ZOOM Etude pour site internet

Département d’oncologie Doc Nr: UIC-MOP-APP-023
Centre de Thérapies Expérimentales ZOOM Etude pour site Internet
Unité d’Investigation Clinique (UIC)
Version 01 du 16 JUL 2015 Imprimé le 06 Apr 2017 17:10 par Sviguetc
Ecrit par:
SVC
Vérifié par:
DBO
Approuvé par:
KEL
Distribué par:
KEL
Copie
Conforme
Page:
1 of 2
Appendix
ZOOM Etude pour site internet
Indication
NSCLC récidivant ou de stade IV et naïf de chimiothérapie
Title
An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab
plus Ipilimumab, or Nivolumab plus platinum doublet chemotherapy
versus platinum doublet chemotherapy in Subjects with Chemotherapy-
Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer
Protocol ID
BMS CA 209-227
Phase
III
Sponsor
BMS
Principal
Investigator
Dr. S. Peters
Primary Objective
The purpose of this study is to show that nivolumab, or nivolumab plus
ipilimumab, or nivolumab plus platinum-doublet chemotherapy improves
progression free survival and/or overall survival compared with
chemotherapy in subjects advanced lung cancer
Inclusion/exclusio
n criteria
Inclusion criteria
 Subjects with histologically confirmed Stage IV or recurrent NSCLC
squamous or non-squamous histology, with no prior systemic
anticancer therapy
 Subjects must have programmed death-ligand 1 (PD-L1)
immunohistochemical testing, with results, performed by the central lab
during the Screening period
 Eastern Cooperative Oncology Group Performance Status of ≤ 1
 Measurable disease by CT or MRI per response evaluation criteria in
solid tumors version 1.1 (RECIST 1.1) criteria
Exclusion criteria
 Subjects with untreated Central nervous system (CNS) metastases are
excluded
 Subjects with an active, known or suspected autoimmune disease are
excluded
 Any positive test for hepatitis B virus or hepatitis C virus or human

Département d’oncologie Doc Nr: UIC-MOP-APP-023
Centre de Thérapies Expérimentales ZOOM Etude pour site Internet
Unité d’Investigation Clinique (UIC)
Version 01 du 16 JUL 2015 Imprimé le 06 Apr 2017 17:10 par Sviguetc
Ecrit par:
SVC
Vérifié par:
DBO
Approuvé par:
KEL
Distribué par:
KEL
Copie
Conforme
Page:
2 of 2
immunodeficiency virus (HIV) indicating acute or chronic infection