LGH 21524 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% (RELATIVITY1093)

Study on Investigational Medication with Chemotherapy for Later Stage Non-Small Cell Lung Cancer

Enrolling By Invitation
18 years or above
All
Phase 3
1000 participants needed
1 Location

Brief description of 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%

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-small Cell Lung Cancer
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the effectiveness of an investigational medication combined with chemotherapy compared to another treatment with chemotherapy for patients with advanced non-small cell lung cancer. The focus is on those with a specific protein expression called PD-L1. The study aims to understand how well the investigational medication works in treating this condition.

Participants in the study will be randomly assigned to receive either the investigational medication with chemotherapy or the comparison treatment with chemotherapy. The study will involve regular check-ups and monitoring to assess how the treatment is working. Participants will undergo various tests, including imaging scans like CT or MRI, to measure the disease's response to the treatment.

  • Who can participate: Adults with stage IV or recurrent non-small cell lung cancer of non-squamous histology can participate if they have not received prior treatment for advanced disease. They must have a PD-L1 expression of 1% or higher and a life expectancy of at least three months. Key exclusions include having certain genetic mutations or untreated brain metastases.
  • Study details: Participants will receive either the investigational medication with chemotherapy or a different treatment with chemotherapy. They will be closely monitored to evaluate the treatment's effects. An inactive substance that looks like the investigational medicine but does not contain any medicine is not used in this study.
Updated on 20 Jul 2026. Study ID: 24-1960
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