Appendix ZOOM Etude pour site internet

Doc Nr: UIC-MOP-APP-023
ZOOM Etude pour site Internet
Département d’oncologie
Centre de Thérapies Expérimentales
Unité d’Investigation Clinique (UIC)
Appendix
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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 ChemotherapyNaïve 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
Inclusion/exclusio
n criteria
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 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
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Département d’oncologie
Centre de Thérapies Expérimentales
Unité d’Investigation Clinique (UIC)
Doc Nr: UIC-MOP-APP-023
ZOOM Etude pour site Internet
immunodeficiency virus (HIV) indicating acute or chronic infection
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