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OncoMatch/Clinical Trials/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%

Is NCT06561386 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for non-small cell lung cancer.

Phase 3RecruitingBristol-Myers SquibbNCT06561386Data as of May 2026

Treatment: Nivolumab · Relatlimab · Pembrolizumab · Carboplatin · Pemetrexed · CisplatinThe 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%

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) overexpression (PD-L1 ≥ 1% Tumor Cell (TC) score)

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

Excluded: EGFR sensitizing mutation

Participants with epidermal growth factor receptor (EGFR)...mutations that are sensitive to available targeted inhibitor therapy

Excluded: ALK fusion

Participants with...anaplastic lymphoma kinase (ALK)...mutations that are sensitive to available targeted inhibitor therapy

Excluded: ROS1 fusion

Participants with...ROS-1 mutations that are sensitive to available targeted inhibitor therapy

Excluded: BRAF V600E

Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy

Excluded: RET activating mutation

participants with known activating rearranged during transfection (RET) mutations...are excluded

Excluded: NTRK1 fusion

participants with known...neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded

Excluded: NTRK2 fusion

participants with known...neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded

Excluded: NTRK3 fusion

participants with known...neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded

Disease stage

Required: Stage IV

Metastatic disease required

Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-PD-1 therapy

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

Cannot have received: anti-PD-L1 therapy

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

Cannot have received: anti-PD-L2 therapy

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

Cannot have received: anti-CTLA-4 therapy

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

Cannot have received: checkpoint inhibitor

prior treatment with...other antibody or drug targeting T-cell co-stimulation or checkpoint pathways

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Southern Arizona VA Health Care System · Tucson, Arizona
  • Local Institution - 0112 · Los Angeles, California
  • University of California Davis (UC Davis) Comprehensive Cancer Center · Sacramento, California
  • San Francisco Oncology Associates · San Francisco, California
  • UCLA Hematology/Oncology - Santa Monica · Santa Monica, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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