NCT06561386Recruiting
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%
Summary
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%
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, India, Ireland, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
- Sponsor
- Bristol-Myers Squibb(Industry)
- Protocol no.
- CA224-1093
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Drug
Treatments studied
- Nivolumab
- Relatlimab
- Pembrolizumab
- Carboplatin
- Pemetrexed
- Cisplatin
Locations · 237
- Dijon, FranceCentre Hospitalier Universitaire (CHU) Dijon Bourgogne - Hôpital François MiterrandRecruiting at this site
- Brest, FranceCHRU de BrestRecruiting at this site
- Toulouse, FranceCHU de Toulouse - Hopital LarreyRecruiting at this site
- Vandœuvre-lès-Nancy, FranceCentre Hospitalier Régional Universitaire de Nancy - Hôpitaux de BraboisRecruiting at this site
- Lille, FranceCHU Lille - Institut Coeur PoumonRecruiting at this site
- Toulon, FranceCentre Hospitalier intercommunal de Toulon La Seyne sur MerRecruiting at this site
- Pierre-Bénite, FranceCentre Hospitalier Lyon SudRecruiting at this site
- Avignon, FranceSainte Catherine Institut du Cancer Avignon ProvenceRecruiting at this site
- Bayonne, FranceCentre Hospitalier de la Côte BasqueRecruiting at this site
- Bordeaux, FranceCHU de Bordeaux Hopital Saint AndreRecruiting at this site
- Marseille, FranceAssistance Publique Hôpitaux de Marseille - Hôpital NordRecruiting at this site
- Paris, FranceHopitaux Universitaires Paris Centre-Hopital CochinRecruiting at this site
- Paris, FranceInstitut CurieRecruiting at this site
- Esslingen am Neckar, GermanyKlinikum EsslingenRecruiting at this site
- Ulm, GermanyBundeswehrkrankenhaus UlmRecruiting at this site
- Kempten (Allgäu), GermanyKlinikverbund AllgaeuRecruiting at this site
- München, GermanyKlinikum der Ludwig-Maximilians-Universitaet MuenchenRecruiting at this site
- Marburg, GermanyUniversitätsklinikum MarburgRecruiting at this site
- Hanover, GermanyPraxis Onkologie am RaschplatzRecruiting at this site
- Dortmund, GermanyGemeinschaftspraxis fuer Haematologie & Onkologie - DortmundRecruiting at this site
- Herne, GermanyEvangelisches Krankenhaus Herne - EickelRecruiting at this site
- Münster, GermanyUniversitätsklinikum Münster - Albert Schweitzer CampusRecruiting at this site
- Chemnitz, GermanyKlinikum ChemnitzRecruiting at this site
- Großhansdorf, GermanyLungenClinic GrosshansdorfRecruiting at this site
- Lübeck, GermanyUniversitatsklinikum Schleswig-HolsteinRecruiting at this site
- Berlin, GermanyCharité Campus Virchow-KlinikumRecruiting at this site
- Bonn, GermanyUniversitätsklinikum BonnRecruiting at this site
- Essen, GermanyUniversitaetsklinikum EssenRecruiting at this site
- Gauting, GermanyAsklepios Klinik Gauting GmbHRecruiting at this site
- Bari, ItalyInstituto Tumori Giovanni Paolo IIRecruiting at this site
In total, worldwide, 237 of the 329 sites listed in the registry are recruiting; the other 92 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 23, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 207 more locations
Other identifiers
- 2024-513682-40 · other identifier
- U1111-1306-8896 · other identifier
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.