Etude : M14-239 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : M14-239

Nom :

Traitement : Métastasique ou localement avancé

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 11/09/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ 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 study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2).

Phase : II

Stade : Localement avancé à Métastatique

2, 3
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histologically confirmed non-small cell lung cancer (NSCLC) with known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site documented status), or histologically documented squamous cell NSCLC.
- Has locally advanced or metastatic NSCLC.
- Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory.
- If a subject meets eligibility criteria for c-Met protein expression level based on archival tissue material, subject must agree to submit fresh tumor material for assessment of c-Met protein expression level prior to first dose of telisotuzumab vedotin
- Has progressed on systemic cytotoxic therapy (or ineligible), and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible) and prior anti-cancer therapies targeting gene alterations (if applicable).
- Have received no more than 2 lines of prior systemic therapy (including no more than 1 line of prior systemic cytotoxic chemotherapy) in the metastatic setting.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Critères de non-inclusion : - Has received prior c-MET-targeted antibody based therapies.
- Has adenosquamous histology.
- Has received anti-cancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy as described in the protocol.
- Has known uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible if they meet requirements described in the protocol.
- Has a clinically significant condition(s) described in the protocol.
- Has unresolved clinically significant adverse events >= grade 2 from prior anticancer therapy, except for alopecia or anemia.
- Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
- Has a history of interstitial lung disease or pneumonitis that required treatment with systemic steroids.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03539536
Promoteur :
ABBVIE
Type de sponsor : Industriel
ABBVIE
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

Ouverture de l'essai : SUSPENDU

MAJ : 11/09/2019