Informazioni generali
  • Categoria della malattia Cancro del polmone (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea, Bellinzona, Losanna, Altro
    (BASEC)
  • Responsabile dello studio Dr. Andreas Schmitt andreasmichael.schmitt@usb.ch (BASEC)
  • Fonte dati BASEC: Importato da 02.07.2025 ICTRP: N/A
  • Ultimo aggiornamento 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 %

  • Categoria della malattia Cancro del polmone (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea, Bellinzona, Losanna, Altro
    (BASEC)
  • Responsabile dello studio Dr. Andreas Schmitt andreasmichael.schmitt@usb.ch (BASEC)
  • Fonte dati BASEC: Importato da 02.07.2025 ICTRP: N/A
  • Ultimo aggiornamento 02.07.2025 14:45

Descrizione riassuntiva dello studio

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)

Intervento studiato

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)

Malattie studiate

Non-Small Cell Lung Cancer

(BASEC)

Criteri di partecipazione
- 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)

Criteri di esclusione
- 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)

Luogo dello studio

Basilea, Bellinzona, Losanna, Altro

(BASEC)

Münsterlingen

(BASEC)

non disponibile

Sponsor

Bristol-Myers Squibb SA, Steinhausen

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Dr. Andreas Schmitt

+41612655074

andreasmichael.schmitt@usb.ch

Universitätsspital Basel

(BASEC)

Informazioni scientifiche

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica svizzera nord-ovest/centrale EKNZ

(BASEC)

Data di approvazione del comitato etico

02.07.2025

(BASEC)


ID di studio ICTRP
non disponibile

Titolo ufficiale (approvato dal comitato etico)
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)

Titolo accademico
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
non disponibile

Intervento studiato
non disponibile

Tipo di studio
non disponibile

Disegno dello studio
non disponibile

Criteri di inclusione/esclusione
non disponibile

non disponibile

Endpoint primari e secondari
non disponibile

non disponibile

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
non disponibile

ID secondari
non disponibile

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile