Etude de phase 2, randomisé, évaluant l’efficacité et la tolérance d’un traitement associant le relatlimab, le nivolumab et une chimiothérapie par rapport au nivolumab seul associé à une chimiothérapie, comme traitement de 1ère intention, chez des patients atteints d’un cancer du poumon non à petites cellules (CPNPC) de stade IV ou récidivant

Essai clinique

Type : Industriel
Statut : Ouvert
Phase : II
Étape du traitement : Traitements combinés
Date d'ouverture : 17/02/2021
Date clôture : 16/09/2025
Promoteur : Bristol-Myers Squibb
Progression du cancer: Loco-régional et à distance
Résumé :

The purpose of this study is to assess the safety profile of nivolumab plus relatlimab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves progression free survival (PFS) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

Domaines/spécialités :
  • Cancers thoraciques respiratoires
    • Cancer bronchique non à petites cellules
Pathologies :
  • Tumeur maligne des bronches et du poumon - Cim10 : C34
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Critères d’inclusion :
  • Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization
  • Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria
  • No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease
Critères d’exclusion :
  • Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy
  • Untreated CNS metastases
  • Leptomeningeal metastases (carcinomatous meningitis)
  • Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease)
  • Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Centre d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Dr FRAISSE
Prénom : Cléa
Téléphone : Non disponible
Email : cfraisse@cgfl.fr
CONTACT TECHNIQUE
Nom : MUGNIER
Prénom : Suzy
Téléphone : 03 80 73 77 52
Email : smugnier@cgfl.fr

Référentiels Oncologik

  • Cancer bronchique non à petites cellules