Informations générales
  • Catégorie de maladie Cancer du poumon (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Bâle, Bellinzona, Lausanne, Autre
    (BASEC)
  • Responsable de l'étude Dr. Andreas Schmitt andreasmichael.schmitt@usb.ch (BASEC)
  • Source(s) de données BASEC: Importé de 02.07.2025 ICTRP: N/A
  • Date de mise à jour 02.07.2025 14:45
HumRes67042 | SNCTP000006466 | BASEC2025-00411

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy with Pembrolizumab Plus Chemotherapy in Patients with Non-Squamous, Non-Small Cell Lung Cancer Stage IV/Recurrence with PD-L1 Expression ≥ 1 %

  • Catégorie de maladie Cancer du poumon (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Bâle, Bellinzona, Lausanne, Autre
    (BASEC)
  • Responsable de l'étude Dr. Andreas Schmitt andreasmichael.schmitt@usb.ch (BASEC)
  • Source(s) de données BASEC: Importé de 02.07.2025 ICTRP: N/A
  • Date de mise à jour 02.07.2025 14:45

Résumé de l'étude

The aim of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy with Pembrolizumab in combination with chemotherapy in participants with non-squamous, non-small cell lung cancer in stage IV or recurrence with a PD-L1 expression of ≥ 1%.

(BASEC)

Intervention étudiée

Experimental Arm A:

Drug Nivolumab

Fixed dose on specified days

 

Drug Relatlimab

Fixed dose on specified days

 

Drug Carboplatin

Fixed dose on specified days

 

Drug Pemetrexed

Fixed dose on specified days

 

Drug Cisplatin

Fixed dose on specified days

 

 

Active Comparator: Arm B

 

Drug Pembrolizumab

Fixed dose on specified days

 

Drug: Carboplatin

Fixed dose on specified days

 

Drug Pemetrexed

Fixed dose on specified days

 

Drug Cisplatin

Fixed dose on specified days

(BASEC)

Maladie en cours d'investigation

Non-Small Cell Lung Cancer

(BASEC)

Critères de participation
- Participants must have a histologically confirmed non-small cell lung cancer (NSCLC) in stage IV or recurrence with non-squamous histology, for which no prior systemic cancer therapy has been administered as primary treatment for advanced or metastatic disease. - Participants must have measurable disease as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST v1.1 criteria. - Participants must have an ECOG performance status (Eastern Cooperative Oncology Group) of ≤ 1 at screening, which must be confirmed prior to randomization. - Participants must have a life expectancy of at least 3 months at the time of randomization. - Participants must have a measurable PD-L1 value of ≥ 1% tumor cells (TC) in the tested immunohistochemistry test VENTANA PD-L1 (SP263) CDx Assay for the detection of PD-L1 expression. This test is performed by a central laboratory during the screening prior to randomization. (BASEC)

Critères d'exclusion
- Participants must not have untreated metastases in the central nervous system (CNS). - Participants must not have a concurrent malignancy requiring treatment. - Participants must not have an active autoimmune disease. - Participants must not have a history of interstitial lung disease or pneumonitis that requires oral or intravenous (IV) glucocorticoid treatment to support therapy. - Participants must not have a history of myocarditis. - Participants must not have received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways. - Additional inclusion and exclusion criteria defined in the study protocol apply. - Female participants must not be pregnant or breastfeeding. - Participants must not have leptomeningeal metastases (carcinomatous meningitis). (BASEC)

Lieu de l’étude

Bâle, Bellinzona, Lausanne, Autre

(BASEC)

Münsterlingen

(BASEC)

non disponible

Sponsor

Bristol-Myers Squibb SA, Steinhausen

(BASEC)

Contact pour plus d'informations sur l'étude

Personne de contact en Suisse

Dr. Andreas Schmitt

+41612655074

andreasmichael.schmitt@usb.ch

Universitätsspital Basel

(BASEC)

Informations scientifiques

non disponible

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

(BASEC)

Date d'approbation du comité d'éthique

02.07.2025

(BASEC)


Identifiant de l'essai ICTRP
non disponible

Titre officiel (approuvé par le comité d'éthique)
A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and with Tumor Cell PD-L1 Expression ≥ 1% (BASEC)

Titre académique
non disponible

Titre public
non disponible

Maladie en cours d'investigation
non disponible

Intervention étudiée
non disponible

Type d'essai
non disponible

Plan de l'étude
non disponible

Critères d'inclusion/exclusion
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non disponible

Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
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Résultats de l'essai

Résumé des résultats

non disponible

Lien vers les résultats dans le registre primaire

non disponible