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 %
Summary description of the study
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 under investigation
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)
Disease under investigation
Non-Small Cell Lung Cancer
(BASEC)
- 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)
Exclusion criteria
- 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)
Trial sites
Basel, Bellinzona, Lausanne, Other
(BASEC)
Münsterlingen
(BASEC)
Sponsor
Bristol-Myers Squibb SA, Steinhausen
(BASEC)
Contact
Contact Person Switzerland
Dr. Andreas Schmitt
+41612655074
andreasmichael.schmitt@clutterusb.chUniversitätsspital Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
02.07.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available