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NCT04623775CompletedPhase 2

A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

A Phase 2 Randomized Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
468 (actual)
First submitted
5 Nov 2020
Start date
17 Feb 2021
Primary completion date
11 Jan 2024
Lead sponsor
Bristol-Myers Squibb
Diseases
Lung cancer
NCT number
NCT04623775
EU CT number
2023-508372-10-00
EudraCT number
2020-004026-31

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 468
  • From 17 Feb 2021 to the primary completion date, 11 Jan 2024
  • 114 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease).

Lab values

  • Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy.
  • Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

Other

  • Untreated CNS metastases.
  • Leptomeningeal metastases (carcinomatous meningitis).
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization.
  • Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria.
  • No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (114)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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CórdobaArgentinaUnknown status
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Cuiudad Autonoma de Buenos AiresArgentinaUnknown status
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La RiojaArgentinaUnknown status
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Río CuartoArgentinaUnknown status
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RosarioArgentinaUnknown status
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ViedmaArgentinaUnknown status
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GrazAustriaUnknown status
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ViennaAustriaUnknown status
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AdelaideAustraliaUnknown status
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BallaratAustraliaUnknown status
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BendigoAustraliaUnknown status
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Box HillAustraliaUnknown status
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CamperdownAustraliaUnknown status
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FrankstonAustraliaUnknown status
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GosfordAustraliaUnknown status
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MurdochAustraliaUnknown status
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NedlandsAustraliaUnknown status
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TamworthAustraliaUnknown status
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
Az Maria Middelares Gent
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GentBelgiumCompleted
Algemeen Ziekenhuis Delta
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RoeselareBelgiumCompleted
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BarretosBrazilUnknown status
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IjuíBrazilUnknown status
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NatalBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Rio de JaneiroBrazilUnknown status
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Santo AndréBrazilUnknown status
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São PauloBrazilUnknown status
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São PauloBrazilUnknown status
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BaselSwitzerlandUnknown status
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Sankt GallenSwitzerlandUnknown status
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SantiagoChileUnknown status
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SantiagoChileUnknown status
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SantiagoChileUnknown status
Vivantes Netzwerk fuer Gesundheit GmbH
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BerlinGermanyCompleted
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyCompleted
LungenClinic Grosshansdorf GmbH
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GrosshansdorfGermanyCompleted
SLK-Kliniken Heilbronn GmbH
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LoewensteinGermanyCompleted
Philipps-Universitaet Marburg
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MarburgGermanyCompleted
MVZ fuer Haematologie und Onkologie Ravensburg GmbH
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RavensburgGermanyCompleted
Institut Catala d'Oncologia
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BadalonaSpainCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Regional de Málaga
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MálagaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Centr Georges Francois Leclerc
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DijonFranceCompleted
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceCompleted
Institut Curie
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ParisFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Unite De Recherche Clinique HIA Begin
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Saint-MandeFranceCompleted
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LeicesterUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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MiddlesbroughUnited KingdomUnknown status
St Vincent's University Hospital
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Dublin 4IrelandCompleted
Beaumont Hospital
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Dublin 9IrelandCompleted
Azienda Ospedaliera Ospedali Riuniti Marche Nord
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PesaroItalyCompleted
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Mexico CityMexicoUnknown status
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MonterreyMexicoUnknown status
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San Pedro Garza GarcíaMexicoUnknown status
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TolucaMexicoUnknown status
Rijnstate Ziekenhuis Stichting
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ArnhemNetherlandsCompleted
Ziekenhuis St Jansdal
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HarderwijkNetherlandsCompleted
Mandziuk Slawomir - Specjalistyczna Praktyka Lekarska
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LublinPolandCompleted
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
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LublinPolandCompleted
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaCompleted
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaCompleted
Oncolab S.R.L.
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CraiovaRomaniaCompleted
Onco Clinic Consult S.A.
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CraiovaRomaniaCompleted
Oncocenter Oncologie Clinica S.R.L
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TimișoaraRomaniaCompleted
Arkhangelsk Clinical Oncological Dispensary
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ArkhangelskRussiaUnknown status
FSBI &quot,Research Institute of Influenza named after A.A. Smorodintsev &quot,of the MoH of the Rus
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Saint PetersburgRussiaUnknown status
Llc, Eurocityclinic
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Saint PetersburgRussiaUnknown status
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AthensUnited StatesUnknown status
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CincinnatiUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DuarteUnited StatesUnknown status
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DurhamUnited StatesUnknown status
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GreenvilleUnited StatesUnknown status
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HarlingenUnited StatesUnknown status
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Howell TownshipUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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Johnson CityUnited StatesUnknown status
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LancasterUnited StatesUnknown status
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LexingtonUnited StatesUnknown status
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LouisvilleUnited StatesUnknown status
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MineolaUnited StatesUnknown status
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MorgantownUnited StatesUnknown status
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New HavenUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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OmahaUnited StatesUnknown status
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OrangeUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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Port Saint LucieUnited StatesUnknown status
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ProvidenceUnited StatesUnknown status
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ScarboroughUnited StatesUnknown status
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SpokaneUnited StatesUnknown status
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The BronxUnited StatesUnknown status
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TylerUnited StatesUnknown status
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WichitaUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.