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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%

Study acronym: RELATIVITY1093
StatusRecruiting
PhasePhase 3
Started2024-10-07
View on ClinicalTrials.gov ↗

Amendment history

2026-09-11
Study Status, Contacts/Locations v33
Trial sites expanded: 322 → 326 locations
2026-08-14
Study Status, Contacts/Locations v32
Study sites320→322
2026-07-17
Study Status, Contacts/Locations v31
Study sites320 entries, revised
LocalASST InstitutionGrande -Ospedale 0465Metropolitano Niguarda LocalHospital InstitutionArnau -de 0411Vilanova LocalTC InstitutionSaglik -Bakanligi 0364Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
2026-06-22
Study Status, Contacts/Locations v30
Trial sites expanded: 312 → 320 locations
2026-05-19
Study Status, Contacts/Locations v29
Trial sites expanded: 299 → 312 locations
2026-04-28
Study Status, Contacts/Locations v28
Trial sites expanded: 282 → 299 locations
2026-03-30
Study Status, Contacts/Locations v27
Study sites280→282
2026-03-04
Study Status, Contacts/Locations v26
Study sites279→280
2026-02-02
Study Status, Contacts/Locations, IPDSharing v25
Study sites278→279
2026-01-05
Study Status, Contacts/Locations v24
Study sites278 entries, revised
The First Affiliated Hospital, Sun Yat-sen University LocalInstitut InstitutionCurie Tata -Memorial 0095 Local Institution - 0336Hospital Kindai University Hospital- Cancer OsakasayamaTreamtent CampusClinic and Clinical Trials Sa de Cv LocalArké InstitutionSMO -S.A. 0170de C.V. LocalLeicester InstitutionRoyal - 0172 Local Institution - 0026Infirmary
2025-12-01
Study Status, Contacts/Locations v23
Study sites277→278
2025-11-04
Study Status, Contacts/Locations v22
Study sites277 entries, revised
Hospital Privado deDe La Comunidad LocalUniversitätsklinikum InstitutionKrems Klinik Floridsdorf CTO - 0314 LocalCentro Institutionde -Tratamento 0293 Local Institution - 0375Oncológico The First Affiliated Hospital, Sun Yat- sen University Sichuan Cancer hospitalHospital CHU de Toulouse - Hopital Larrey Centre Hospitalier Lyon Sud Assistance Publique Hôpitaux de Marseille - Hôpital Nord Istituto Nazionale Tumori Regina Elena Tauranga Hospital Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu" CHUAC-Hospital Teresa Herrera Local Institution - 0090 Local Institution - 0157 Local [...] [...]
2025-10-10
Study Status, Contacts/Locations v21
Study sites277 entries, revised
LocalThe InstitutionFirst affiliated hospital of Nanchang University (Xianghu campus) Shanxi Cancer Hospital CHU Lille - 0451Institut Coeur Poumon LocalKlinikum InstitutionEsslingen Klinikum der Ludwig-Maximilians-Universitaet Muenchen Klinikum Chemnitz LungenClinic Grosshansdorf Charité Campus Virchow-Klinikum Universitätsklinikum Bonn Universitaetsklinikum Essen Asklepios Klinik Gauting GmbH Instituto Tumori Giovanni Paolo II A.O.R.N. Ospedale dei Colli - 0435Monaldi V. LocalCasa Institutiondi Cura Dott. Pederzoli Atrium-Orbis - 0096Zuyderland Medisch Centrum Heerlen LocalHospital Institutio [...] [...]
2025-09-22
Study Status, Contacts/Locations v20
Study sites277 entries, revised
LocalRigshospitalet Universitätsklinikum InstitutionMarburg Instituto -Português 0125de Oncologia do Porto Francisco Gentil, EPE LocalCHA InstitutionBundang -Medical 0313Center, CHA University LocalHospital InstitutionUniversitario -Ramón 0403 Localy Institution - 0450 Local Institution - 0413Cajal
2025-09-05
Study Status, Contacts/Locations v19
Study sites276→277
2025-08-19
Study Status, Contacts/Locations v18
Completion date2033-11-11→2032-08-04
Study sites275→276
2025-07-29
Study Status, Contacts/Locations v17
Study sites273→275
2025-07-14
Study Status, Contacts/Locations v16
Study sites273 entries, revised
LocalSouthern InstitutionArizona -VA 0368Health Care System LocalUniversity Institutionof -California 0304Davis (UC Davis) Comprehensive Cancer Center LocalWMCHealth InstitutionAdvanced -Physician 0356Services LocalVeterans InstitutionAffairs -New 0392York Harbor Healthcare System LocalHospital InstitutionBritánico -de 0379Buenos Aires LocalInstituto InstitutionOncológico -de 0370Córdoba LocalUZ InstitutionBrussel Liga -Norte 0039Riograndense Contra o Câncer LocalAarhus InstitutionUniversitetshospital, -Skejby Centre 0151Hospitalier de la Côte Basque LocalNarayana InstitutionSuperspecialty -Ho [...] [...]
2025-06-16
Study Status, Contacts/Locations v15
Study sites273 entries, revised
LocalUniversity Institutionof -Cincinnati 0141Medical Center LocalOncocentro InstitutionApys The -Second 0452 LocalPeople's InstitutionHospital -of 0424Neijiang
2025-05-28
Study Status, Contacts/Locations v14
Study sites277→273
2025-05-07
Study Status, Contacts/Locations v13
Study sites277 entries, revised
LocalMemorial InstitutionHospital -West New 0162Mexico VA Healthcare System LocalHospital InstitutionPrivado -de 0381Comunidad LocalHunan InstitutionCancer - 0236 Local Institution - 0072Hospital
2025-04-15
Study Status, Contacts/Locations v12
Study sites274→277
2025-03-28
Study Status, Contacts/Locations v11
Study sites262→274
2025-03-05
Study Status, Contacts/Locations v10
Study sites258→262
2025-02-18
Study Status, Contacts/Locations, References v9
Study sites242→258
2025-01-28
Study Status, Contacts/Locations v8
Study sites231→242
2025-01-14
Study Identification, Study Status, Study Description, Conditions, Study Design, Outcome Measures, Eligibility, Contacts/Locations v7
Enrollment target800→1000
Study sites217→231
Eligibility criteria+555 characters
[...] ll Lung Cancer (NSCLC) of non-squamous (NSQ) histology with tumorno cellprior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. Participants must have measurable PD-L1 expression≥ 1% toTumor 49%Cell as(TC) determinedscore by athe 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 tomog [...] formance status of ≤ 1 at screening. Participants must have noa priorlife systemicexpectancy anti-ca [...] [...]
Secondary endpoints7 to 8 entries
OS in randomized participants with PD-L1 ≥ 1% Progression-free survival (PFS) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Primary endpoints1 entry, revised
Overall survival (OS) in randomized participants with PD-L1 1% to 49%
Study title+10 characters
[...] ecurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1-49%
2024-12-11
Study Status, Contacts/Locations, References v6
Study sites205→217
2024-11-25
Study Status, Contacts/Locations v5
Study sites200→205
2024-10-29
Study Status, Contacts/Locations v4
Study sites191→200
2024-10-21
Study Status, Contacts/Locations v3
Start dateestimated 2024-09-20→confirmed 2024-10-07
Study sites174→191
2024-09-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v2
Trial statusNot Yet Recruiting→Recruiting
Study sites174 entries, revised
LocalBozeman InstitutionHealth -Deaconess 0308Hospital LocalRenown InstitutionRegional -Medical 0207Center
2024-09-10
Study Status, Contacts/Locations v1
Study sites172→174
2024-08-16
Original filing
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%
Trial Details
NCT Number NCT06561386
Lead Sponsor Bristol-Myers Squibb
Conditions Non-small Cell Lung Cancer
Enrollment 1,000 participants
Start Date 2024-10-07
Primary Completion 2030-07-30 (estimated)
Study Completion 2032-08-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-23