Condition

Non-small Cell Lung Cancer 

Purpose of the study

The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%. NCT06561386    

Official Title

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 Stage IV or Recurrent Non-squamous Non-small Cell Lung Cancer. 

Who is eligible to participate?

Inclusion criteria

• Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.

• Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization.

• Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.

• Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.

• Participants must have a life expectancy of at least 3 months at the time of randomization.

Exclusion criteria:

• Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded.

• Participants with know BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy, participants with know activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible.

• Participants must not have untreated central nervous system (CNS) metastases.

• Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane