Etude : CINC280I12201 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : CINC280I12201

Nom :

Traitement : Métastatique ou localement avancé

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 10/07/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Randomized, Open Label, Multicenter Phase II Study Evaluating the Efficacy and Safety of Capmatinib (INC280) Plus Pembrolizumab Versus Pembrolizumab Alone as First Line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer With PD-L1≥ 50%

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The purpose is to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects.

STUDY ARMS:
- Experimental: Combination arm : Capmatinib 400 mg twice a day + Pembrolizumab 200 mg every 3 weeks
- Active Comparator: monotherapy : Pembrolizumab 200 mg every 3 weeks

CURRENT PRIMARY OUTCOME:
Progression-free survival (PFS) based on local investigator assessment as per RECIST 1.1 [ Time Frame: 24 months ]

CURRENT SECONDARY OUTCOMES:
- Objective response rate (ORR) based on local investigator assessment as per RECIST 1.1 [ Time Frame: 24 months ]
- Disease control rate (DCR) based on local investigator assessment as per RECIST 1.1 [ Time Frame: 24 months ]
- Time-to-response (TTR) based on local investigator assessment as per RECIST 1.1 [ Time Frame: 24 months ]
- Duration of response (DOR) based on local investigator assessment as per RECIST 1.1 [ Time Frame: 24 months ]
- Overall survival (OS) [ Time Frame: 38 months ]
- Antidrug antibodies (ADA) of pembrolizumab [ Time Frame: 24 months ]
- AUC of Capmatinib derived from plasma capmatinib concentration [ Time Frame: 24 months ]
- Ctrough of Pembrolizumab derived from serum pembrolizumab concentration [ Time Frame: 24 months ]
- Cmax of Capmatinib derived from plasma capmatinib concentration [ Time Frame: 24 months ]
- Tmax of Capmatinib derived from plasma capmatinib concentration [ Time Frame: 24 months ]


Phase : II

Stade : Localement avancé à Métastatique

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting
- Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement statu
- Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS ≥ 50%)
- ECOG performance status score ≤ 1
- Have at least 1 measurable lesion by RECIST 1.1
- Have adequate organ function

-- Other protocol-defined inclusion/exclusion criteria may apply --

Critères de non-inclusion : - Prior treatment with a MET inhibitor or HGF-targeting therapy
- Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
- Have untreated symptomatic central nervous system (CNS) metastases
- Clinically significant, uncontrolled heart diseases
- Prior palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study treatment

-- Other protocol-defined inclusion/exclusion criteria may apply --
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04139317
Promoteur :
Novartis Pharmaceuticals
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Alexis Cortot

TEC / ARC / IDE :
Eric Wasielewski
eric.wasielewski@
chru-lille.fr
03.20.44.56.12

Statut de l'essai : OUVERT

MAJ : 10/07/2020