eNERGY Protocole signe V2.0 2017.11.06.pdf


Preview of PDF document energy-protocole-signe-v2-0-2017-11-06.pdf

Page 1 23460

Text preview


ENERGY

Trial Code Sponsor 35RC16_9734 / GFPC 08-2015 / BMS CA209-449

SPONSOR :

CHU Rennes (Rennes University Hospital Centre)

TRIAL CODE :

SPONSOR 35RC16_9734
GFPC 08-2015
BMS CA209-449

EudraCT no. :

2017-002842-60

PRODUCT/COMPOUND

Nivolumab / Ipilimumab

COMPLETE TITLE

Etude randomisée de phase III testant l’association du
nivolumab et de l’ipilimumab versus un doublet à base de
carboplatine dans le traitement de première ligne du CBNPC
chez des patients PS 2 ou de plus de 70 ans.
Randomised phase III study testing nivolumab and ipilimumab
versus a carboplatin based doublet in first line treatment of PS 2
or elderly (more than 70 years old) patients with advanced nonsmall cell lung cancer.

CLINICAL PHASE

III

INDICATION(S) (TARGET)

Advanced non small cell lung cancer

COORDINATING INVESTIGATOR

Dr Herve Lena
Service de pneumologie
CHU of Rennes - Hôpital Pontchaillou
2 rue Henri Le Guilloux
35033 Rennes Cedex 9
France

PROTOCOL VERSION NO.

2.0

DATE OF PROTOCOL

06/11/2017

CPP

Approved on 28/09/2017
By the Committee for the Protection of Persons SOOM IV of
Limoges

ANSM

Date of authorisation: 12/09/2017
Authorisation no.: 170472A-12

THIS CONFIDENTIAL DOCUMENT IS THE PROPERTY OF CHU RENNES. NO UNPUBLISHED
INFORMATION CONTAINED IN THIS DOCUMENT CAN BE DISCLOSED WITHOUT THE PRIOR
WRITTEN AUTHORISATION OF CHU RENNES.

Protocole

Version 2.0 du 06/11/2017

Page 2/60