Recruiting NCT06561386

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%

Phase III Interventional Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Nivolumab, Relatlimab, Pembrolizumab, Carboplatin.
Who it may be relevant to: Registry conditions: Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +26
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%

Overview

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%

Interventions

Drug Nivolumab
Specified dose on specified days
Drug Relatlimab
Specified dose on specified days
Drug Pembrolizumab
Specified dose on specified days
Drug Carboplatin
Specified dose on specified days
Drug Pemetrexed
Specified dose on specified days
Drug Cisplatin
Specified dose on specified days

Primary outcome measures

Overall survival (OS) in randomized participants with PD-L1 1% to 49% [Time frame: Up to 5 years]

Secondary outcome measures (8)

OS in randomized participants with PD-L1 ≥ 1% [Time frame: Up to 5 years]
Progression-free survival (PFS) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR) [Time frame: Up to 5 years]
Overall response rate (ORR) [Time frame: Up to 5 years]
Duration of response (DoR) [Time frame: Up to 5 years]
Number of participants with adverse events (AEs) [Time frame: Up to 2.5 years]
Number of participants with serious adverse events (SAEs) [Time frame: Up to 2.5 years]
Number of participants with immune-mediated adverse events (IMAEs) [Time frame: Up to 2.5 years]
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score [Time frame: Up to 2 years]

Eligibility criteria

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 must not be pregnant and/or breastfeeding.
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 known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known 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 leptomeningeal metastases (carcinomatous meningitis).
Participants must not have concurrent malignancy requiring treatment.
Participants must not have an active autoimmune disease.
Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management.
Participants must not have a history of myocarditis.
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.
Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment