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NCT02998528CompletedPhase 3

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

Source: ClinicalTrials.gov · Last updated 6 Jan 2026

Brief summary (registry, in English)

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
505 (actual)
First submitted
16 Dec 2016
Start date
4 Mar 2017
Primary completion date
8 Sept 2021
Lead sponsor
Bristol-Myers Squibb
Diseases
Lung cancer
NCT number
NCT02998528
EU CT number
2022-501360-18-00
EudraCT number
2016-003536-21

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 505
  • From 4 Mar 2017 to the primary completion date, 8 Sept 2021
  • 135 sites in 15 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.

Prior treatment

  • Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
    • Other protocol defined inclusion/exclusion criteria apply

Other illness

  • Presence of locally advanced, inoperable or metastatic disease
  • Participants with active, known or suspected autoimmune disease

Who the study is looking for

  • Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
  • Lung function capacity capable of tolerating the proposed lung surgery
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Available tissue of primary lung tumor

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

Full criteria on ClinicalTrials.gov

Sites (135)

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

SiteCityCountrySite status
Local Institution - 0022
Coordinator of this site? Confirm its status
Capital FederalArgentinaUnknown status
Local Institution - 0023
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AireArgentinaUnknown status
Fundacao Pio Xii Hosp Cancer De Barretos
Coordinator of this site? Confirm its status
BarretosBrazilUnknown status
Local Institution - 0077
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Belo HorizonteBrazilUnknown status
Local Institution - 0079
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BrasíliaBrazilUnknown status
Local Institution - 0076
Coordinator of this site? Confirm its status
IjuíBrazilUnknown status
Local Institution - 0073
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Local Institution - 0075
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown status
Local Institution - 0095
Coordinator of this site? Confirm its status
GatineauCanadaUnknown status
Local Institution - 0017
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Local Institution - 0138
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MontrealCanadaUnknown status
Local Institution - 0016
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SaskatoonCanadaUnknown status
Local Institution - 0052
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Trois-RivièresCanadaUnknown status
Local Institution - 0156
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BeijingChinaUnknown status
Local Institution - 0161
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BeijingChinaUnknown status
Local Institution
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Local Institution
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Local Institution - 0175
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ChangshaChinaUnknown status
Local Institution - 0192
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ChangshaChinaUnknown status
Local Institution - 0193
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ChangshaChinaUnknown status
Local Institution - 0178
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ChengduChinaUnknown status
Local Institution - 0190
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GuangzhouChinaUnknown status
Local Institution - 0182
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HangzhouChinaUnknown status
Local Institution - 0189
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HangzhouChinaUnknown status
Local Institution - 0183
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HangzhouChinaUnknown status
Local Institution - 0166
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NanchangChinaUnknown status
Local Institution - 0179
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NanchangChinaUnknown status
Local Institution - 0165
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ShanghaiChinaUnknown status
Local Institution - 0160
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ShanghaiChinaUnknown status
Local Institution - 0163
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TianjinChinaUnknown status
Local Institution - 0180
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Xi'anChinaUnknown status
Local Institution - 0159
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Xi'anChinaUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Institut Curie
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ParisFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
Centre Hospitalier Universitaire De Rennes
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Rennes Cedex 9FranceCompleted
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceCompleted
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceCompleted
Local Institution - 0019
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AthensGreeceUnknown status
Local Institution - 0122
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ThessalonikiGreeceUnknown status
Local Institution
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BudapestHungaryUnknown status
Local Institution
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SzékesfehérvárHungaryUnknown status
Istituto Tumori Bari Giovanni Paolo II
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BariItalyCompleted
IRCCS Ospedale Policlinico San Martino
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GenoaItalyCompleted
University Hospital Of Perugia
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PerugiaItalyCompleted
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyCompleted
Local Institution - 0126
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Bunkyo-kuJapanUnknown status
Local Institution - 0110
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FukushimaJapanUnknown status
Local Institution - 0109
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HiroshimaJapanUnknown status
Local Institution - 0118
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Kashiwa-shiJapanUnknown status
Local Institution - 0111
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Kitakyushu-shiJapanUnknown status
Local Institution - 0133
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KobeJapanUnknown status
Local Institution - 0131
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NagoyaJapanUnknown status
Local Institution - 0108
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OsakaJapanUnknown status
Local Institution - 0127
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OsakaJapanUnknown status
Local Institution - 0119
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Sakai-shiJapanUnknown status
Local Institution - 0147
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SapporoJapanUnknown status
Local Institution - 0148
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SendaiJapanUnknown status
Local Institution - 0120
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Shinjuku-kuJapanUnknown status
Local Institution - 0132
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Sunto-gunJapanUnknown status
Local Institution - 0124
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TokyoJapanUnknown status
Local Institution - 0123
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YokohamaJapanUnknown status
Local Institution - 0097
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BusanSouth KoreaUnknown status
Local Institution - 0098
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HwasunSouth KoreaUnknown status
Local Institution - 0105
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SeoulSouth KoreaUnknown status
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
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BucharestRomaniaCompleted
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaCompleted
Local Institution - 0102
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New Taipei CityTaiwanUnknown status
Local Institution - 0107
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TaichungTaiwanUnknown status
Local Institution - 0099
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TaipeiTaiwanUnknown status
Local Institution - 0100
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TaipeiTaiwanUnknown status
Local Institution - 0027
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AlbanyUnited StatesUnknown status
Local Institution - 0035
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AustinUnited StatesUnknown status
Local Institution - 0151
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BaltimoreUnited StatesUnknown status
Local Institution - 0001
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BaltimoreUnited StatesUnknown status
Texas Oncology
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BedfordUnited StatesUnknown status
St. Vincent Frontier Cancer Center
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BillingsUnited StatesUnknown status
Local Institution - 0008
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BostonUnited StatesUnknown status
Local Institution - 0135
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BurlingtonUnited StatesUnknown status
Local Institution - 0013
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CharlestonUnited StatesUnknown status
Local Institution - 0021
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CharlestonUnited StatesUnknown status
Local Institution - 0015
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ChicagoUnited StatesUnknown status
Local Institution - 0002
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ChicagoUnited StatesUnknown status
Christ Hospital
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CincinnatiUnited StatesUnknown status
MetroHealth Medical Center
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ClevelandUnited StatesUnknown status
Local Institution - 0025
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DenverUnited StatesUnknown status
Local Institution - 0012
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DetroitUnited StatesUnknown status
Local Institution - 0125
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FairfaxUnited StatesUnknown status
Southcoast Center For Cancer
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FairhavenUnited StatesUnknown status
Local Institution - 0153
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Fort BlissUnited StatesUnknown status
Local Institution - 0171
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Fort WayneUnited StatesUnknown status
Local Institution - 0198
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FredericksburgUnited StatesUnknown status
Local Institution - 0121
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GlendaleUnited StatesUnknown status
Local Institution - 0146
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GreenvilleUnited StatesUnknown status
Local Institution - 0009
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HackensackUnited StatesUnknown status
Local Institution - 0090
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HattiesburgUnited StatesUnknown status
Local Institution - 0140
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High PointUnited StatesUnknown status
Local Institution - 0173
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HollywoodUnited StatesUnknown status
Local Institution - 0106
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HoustonUnited StatesUnknown status
Local Institution - 0032
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Las VegasUnited StatesUnknown status
Local Institution - 0170
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LexingtonUnited StatesUnknown status
Local Institution - 0081
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Los AngelesUnited StatesUnknown status
Local Institution - 0186
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LouisvilleUnited StatesUnknown status
Southwest Cancer Center
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LubbockUnited StatesUnknown status
Northwest Georgia Oncology Center, P.C.
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MariettaUnited StatesUnknown status
Local Institution - 0136
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MiamiUnited StatesUnknown status
Intermountain Medical Center
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MurrayUnited StatesUnknown status
Local Institution - 0005
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NashvilleUnited StatesUnknown status
Local Institution - 0092
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NashvilleUnited StatesUnknown status
University Medical Center New Orleans
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New OrleansUnited StatesUnknown status
Local Institution - 0006
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NewtonUnited StatesUnknown status
Local Institution - 0011
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New YorkUnited StatesUnknown status
Illinois Cancer Specialists
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NilesUnited StatesUnknown status
Local Institution - 0054
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OrlandoUnited StatesUnknown status
Orlando Health, Inc.
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OrlandoUnited StatesUnknown status
Local Institution - 0010
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PhiladelphiaUnited StatesUnknown status
Local Institution - 0018
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PittsburghUnited StatesUnknown status
Local Institution - 0007
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PlainvilleUnited StatesUnknown status
Local Institution - 0139
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PortlandUnited StatesUnknown status
Kaiser Permanente
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PortlandUnited StatesUnknown status
Local Institution - 0003
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Salt Lake CityUnited StatesUnknown status
Texas Cancer Center - Sherman
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ShermanUnited StatesUnknown status
Southwest Regional Cancer Clinic
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St. GeorgeUnited StatesUnknown status
Local Institution - 0143
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TylerUnited StatesUnknown status
Indian River Medical Center
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Vero BeachUnited StatesUnknown status
Local Institution - 0026
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WacoUnited StatesUnknown status
Valley Hospital Luckow Pavili
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WestwoodUnited StatesUnknown status
Local Institution - 0149
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ZanesvilleUnited StatesUnknown status
Local Institution - 0093
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AdanaTurkey (Türkiye)Unknown status
Local Institution - 0084
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AnkaraTurkey (Türkiye)Unknown status
Local Institution - 0115
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IstanbulTurkey (Türkiye)Unknown status

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