Etude : CINC280D2201 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : CINC280D2201

Nom :

Traitement : Métastasique ou localement avancé

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 18/09/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Phase II Multicenter Randomized Two-arm Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Pretreated Adult Patients With EGFR Wild-type ALK Rearrangement Negative Advanced/Metastatic Non-small Cell Lung Cancer

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This is a clinical research study and the purpose of the study is to learn whether the combination of the drugs capmatinib plus spartalizumab helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients with NSCLC.

Capmatinib is an oral drug that is called a "targeted" medicine: this means it targets particular processes, which may not be working properly in the cancer cells in your body (called dysregulation) and which may be causing your disease.

Spartalizumab is an antibody (a kind of protein that binds to a specific "target" protein). By blocking its "target" protein, called PD-1, spartalizumab may increase the activity of a certain type of cells in your immune system, which may reduce the growth of your tumor.

Docetaxel is a standard chemotherapy medicine commonly used to treat your type of lung cancer. This standard, anti-cancer medicine is a cytotoxic chemotherapy that is being compared with capmatinib and spartalizumab.

The reason for this study is to find out which of these two treatments (combination of capmatinib plus spartalizumab OR docetaxel alone) helps to control lung cancer better.

Study Arms:
- Experimental: Capmatinib plus spartalizumab
- Active Comparator: Docetaxel

Phase : II

Stade : Localement avancé à Métastasique

3
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histologically confirmed locally advanced/metastatic (stage IIIB/IV), EGFR wild-type, ALK rearrangement negative, non-small cell lung cancer
- Subject has demonstrated progression following one prior platinum doublet and one prior PD-(L)1 checkpoint inhibitor (either alone or in combination, the most recent treatment regimen must have contained a PD-(L)1 checkpoint inhibitor)
- Subjects must be candidates for single agent docetaxel
- Subjects must have at least one lesion evaluable by RECIST 1.1

Critères de non-inclusion : -Prior treatment with a MET inhibitor or HGF (Hepatocyte growth factor) targeting therapy
- Any untreated central nervous system (CNS) lesion
- Use of any live vaccines against infectious diseases within 12 weeks of initiation of study treatment.

Other protocol-defined inclusion/exclusion criteria may apply.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03647488
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 - Marianne Gierczynski
eric.wasielewski@
chru-lille.fr
03.20.44.56.12

Ouverture de l'essai : CLOS

MAJ : 04/09/2019