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Looking for participantsPhase3

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%

Sponsor: Bristol-Myers Squibb

NCT ID: NCT06561386

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Nivolumab (drug), Relatlimab (drug), Pembrolizumab (drug), Carboplatin (drug)
How long the study runs
Study runs about 94 months (dates as stated)
About the drug or intervention
Nivolumab — drug: Specified dose on specified days · Relatlimab — drug: Specified dose on specified days · Pembrolizumab — drug: Specified dose on specified days · Carboplatin — drug: Specified dose on specified days · Pemetrexed — drug: Specified dose on specified days · Cisplatin — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,000
Started
2024-10-07
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer
  • • Phase3 - 1,000 participants
  • • 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%

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-small cell lung cancer

Where?

  • • Exeter - Local Institution - 0441
  • • Dundee - Local Institution - 0349
  • • Larbert - Local Institution - 0271
  • • Glasgow - Local Institution - 0189
  • • +8 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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%

Non-small Cell Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1PD-L1 ≥ 1%EGFRALKRETNTRKBRAFactivating rearranged

Treatment history

Treatments you must have had:

  • ✓ measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1
  • ✓ an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening
  • ✓ a life expectancy of at least 3 months at the time of randomization
  • ✓ oral or intravenous (IV) glucocorticoids to assist with management

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Participants must have cancer that can be measured on scans by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST...
  • ✓Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.
  • ✓Participants must have a expected to live at least 3 $2 at the time of randomization.
  • ✓Exclusion Criteria
See the full 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.

Where Is This Study? (12 UK sites)

Local Institution - 0441

Exeter EX2 5DW, United Kingdom

WITHDRAWN

Local Institution - 0349

Dundee DD1 9SY, United Kingdom

COMPLETED

Local Institution - 0271

Larbert FK5 4WR, United Kingdom

COMPLETED

Local Institution - 0189

Glasgow g12OYN, United Kingdom

NOT_YET_RECRUITING

Local Institution - 0021

London SW3 6JJ, United Kingdom

WITHDRAWN

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Samreen Ahmed, Site 002644 116 229 7246

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Adam Januszewski, Site 0348+44 20 7377 7000

Local Institution - 0001

London SE1 9RT, United Kingdom

NOT_YET_RECRUITING

Sarah Cannon Research Institute UK

London W1G 6AD, United Kingdom

Recruiting
Site contact (verified)
Anja Williams, Site 0464020 3219 5200

Local Institution - 0020

Manchester M20 4BX, United Kingdom

WITHDRAWN

Local Institution - 0024

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

WITHDRAWN

Royal Berkshire Hospital

Reading RG1 5AN, United Kingdom

Recruiting
Site contact (verified)
Shawn Ellis, Site 0463+44 118 322 5111

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09