Etude : CheckMate 9LA / BMS CA 209-9LA



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Dernière MÀJ
Présentation de l'étude
Acronyme : CheckMate 9LA

Nom : BMS CA 209-9LA

Traitement : Métastasique ou localement avancé

Dernière MÀJ : 22/11/2017
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 2 arms:
- Experimental: Chemotherapy/Biologics combined (Ipilimumab, Nivolumab + Carboplatin, Paclitaxel, Pemetrexed, Cisplatin)
- Active Comparator: Chemotherapy Combination (Carboplatin, Paclitaxel, Pemetrexed, Cisplatin)

Phase : III

Stade : IV

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : Liste non exhaustive:
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test [minimum sensitivity 25 units per litre (IU/L) or equivalent units of human chorionic gonadotropin (HCG)] within 24 hours prior to the start of study drug
- WOCBP must agree to follow instructions for methods(s) of contraception for the duration of treatment with nivolumab and 5 months after the last dose of nivolumab (ie 30 days [duration of ovulatory cycle] plus the time required for nivolumab to undergo approximately five half-lives)
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with nivolumab and up to 7 months after the last dose of nivolumab (ie 90 days [duration of sperm turnover] plus the time required for nivolumab to undergo approximately five half-lives)

Critères de non-inclusion : Liste non exhaustive:
- Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
- Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
- Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment
NCT
Promoteur
Contact ARC
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
BRISTOL MYERS SQUIBB
Type de sponsor : Industriel
BRISTOL MYERS SQUIBB - BRISTOL MYERS SQUIBB
00000 HORS FRANCE

Contact ARC :

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
Type d'étude
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Caen - Avenue de la Côte de Nacre - 14033 Caen Cedex - 14000 CAEN

Investigateur :
Emmanuel BERGOT

TEC / ARC / IDE :
Vincent LEON
leon-v@chu-caen.fr

Ouverture de l'essai : CLOS

Type d'étude : Hors ciblage moléculaire / Hors innovation thérapeutique
MAJ : 03/12/2018