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 (Jun 2026). This Phase 3 trial studies multiple treatments for non-small cell lung cancer.
Treatment: Nivolumab · Relatlimab · Pembrolizumab · Carboplatin · Pemetrexed · Cisplatin — 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%
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
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
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 →Frequently asked questions
Is NCT06561386 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 overexpression is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR sensitizing mutation is an exclusion criterion.
Are patients with ALK alterations eligible?
No. ALK fusion is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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