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NCT03215706CompletedPhase 3

A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 17 Dec 2025

Brief summary (registry, in English)

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
719 (actual)
First submitted
11 Jul 2017
Start date
24 Aug 2017
Primary completion date
16 Aug 2019
Lead sponsor
Bristol-Myers Squibb
Diseases
Lung cancer
NCT number
NCT03215706
EU CT number
2023-508757-75-00
EudraCT number
2017-001195-35

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 719
  • From 24 Aug 2017 to the primary completion date, 16 Aug 2019
  • 106 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.

Prior treatment

  • Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
  • Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment
    • Other protocol inclusion/exclusion criteria may apply

Lab values

  • Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 \[L858R\] substitution mutations) are excluded

Who the study is looking for

  • Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
  • Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
  • Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period

Criteria the registry did not label

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Full criteria on ClinicalTrials.gov

Sites (106)

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

SiteCityCountrySite status
Local Institution - 0014
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Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Local Institution - 0030
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CórdobaArgentinaUnknown status
Local Institution - 0028
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Río CuartoArgentinaUnknown status
Local Institution - 0027
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RosarioArgentinaUnknown status
Local Institution - 0026
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ViedmaArgentinaUnknown status
Local Institution - 0040
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Bedford ParkAustraliaUnknown status
Local Institution - 0089
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Box HillAustraliaUnknown status
Local Institution - 0086
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GosfordAustraliaUnknown status
Local Institution - 0036
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HeidelbergAustraliaUnknown status
Local Institution - 0078
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MurdochAustraliaUnknown status
Algemeen Ziekenhuis Delta
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RoeselareBelgiumCompleted
Local Institution - 0064
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BarretosBrazilUnknown status
Local Institution - 0069
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BlumenauBrazilUnknown status
Local Institution - 0063
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IjuíBrazilUnknown status
Local Institution - 0068
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NatalBrazilUnknown status
Local Institution - 0067
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Porto AlegreBrazilUnknown status
Local Institution - 0066
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Rio de JaneiroBrazilUnknown status
Local Institution - 0065
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São José do Rio PretoBrazilUnknown status
Local Institution - 0070
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São PauloBrazilUnknown status
Local Institution - 0082
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MontrealCanadaUnknown status
Local Institution - 0090
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MontrealCanadaUnknown status
Local Institution - 0083
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MontrealCanadaUnknown status
Local Institution - 0080
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RimouskiCanadaUnknown status
Local Institution - 0084
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SantiagoChileUnknown status
Local Institution - 0059
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SantiagoChileUnknown status
Local Institution - 0079
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Viña del MarChileUnknown status
Local Institution - 0139
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BeijingChinaUnknown status
Local Institution - 0113
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BeijingChinaUnknown status
Local Institution - 0106
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ChangchunChinaUnknown status
Local Institution - 0144
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ChangshaChinaUnknown status
Local Institution - 0146
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HaikouChinaUnknown status
Local Institution - 0110
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HangzhouChinaUnknown status
Local Institution - 0112
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ShanghaiChinaUnknown status
Local Institution - 0108
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Xi'anChinaUnknown status
Local Institution - 0111
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ZhejiangChinaUnknown status
Local Institution - 0148
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ZhengzhouChinaUnknown status
Local Institution - 0120
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ZhengzhouChinaUnknown status
Helios Klinikum Emil von Behring GmbH
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BerlinGermanyCompleted
Asklepios Fachkliniken Muenchen-Gauting
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GautingGermanyCompleted
LungenClinic Grosshansdorf GmbH
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GrosshansdorfGermanyCompleted
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
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HemerGermanyCompleted
Robert Bosch Krankenhaus GmbH
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StuttgartGermanyCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
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BarcelonaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Regional de Málaga
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MálagaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceCompleted
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
Local Institution - 0050
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GuildfordUnited KingdomUnknown status
Local Institution - 0049
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LondonUnited KingdomUnknown status
Local Institution - 0048
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TautonUnited KingdomUnknown status
University Hospital Limerick
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LimerickIrelandCompleted
Local Institution - 0042
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LuccaItalyUnknown status
Local Institution - 0041
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MilanItalyUnknown status
Local Institution - 0043
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NaplesItalyUnknown status
Local Institution - 0131
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Akashi-shiJapanUnknown status
Local Institution - 0101
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FukushimaJapanUnknown status
Local Institution - 0135
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Habikino-shiJapanUnknown status
Local Institution - 0119
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Himeji-shiJapanUnknown status
Local Institution - 0138
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HiroshimaJapanUnknown status
Local Institution - 0137
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HiroshimaJapanUnknown status
Local Institution - 0115
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KanazawaJapanUnknown status
Local Institution - 0102
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Kitaadachi-gunJapanUnknown status
Local Institution - 0104
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KobeJapanUnknown status
Local Institution - 0118
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MaebashiJapanUnknown status
Local Institution - 0116
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NiigataJapanUnknown status
Local Institution - 0136
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OkayamaJapanUnknown status
Local Institution - 0130
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OsakaJapanUnknown status
Local Institution - 0103
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Ōsaka-sayamaJapanUnknown status
Local Institution - 0128
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Ota-shiJapanUnknown status
Local Institution - 0127
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SapporoJapanUnknown status
Local Institution - 0100
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Shiwa-gunJapanUnknown status
Local Institution - 0132
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Ube-shiJapanUnknown status
Local Institution - 0134
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YokohamaJapanUnknown status
Local Institution - 0114
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YokohamaJapanUnknown status
Local Institution - 0129
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YokohamaJapanUnknown status
Local Institution - 0061
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GuadalajaraMexicoUnknown status
Local Institution - 0077
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La PazMexicoUnknown status
Local Institution - 0075
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Veracruz, VeracruzMexicoUnknown status
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
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
Local Institution - 0024
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MoscowRussiaUnknown status
Local Institution - 0025
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Saint PetersburgRussiaUnknown status
Local Institution - 0094
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CharlestonUnited StatesUnknown status
Memorial Health Systems
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Colorado SpringsUnited StatesUnknown status
Local Institution - 0095
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ColumbusUnited StatesUnknown status
Local Institution - 0105
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DetroitUnited StatesUnknown status
Local Institution - 0045
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JacksonvilleUnited StatesUnknown status
Local Institution - 0058
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Johnson CityUnited StatesUnknown status
Local Institution - 0006
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LancasterUnited StatesUnknown status
Local Institution - 0004
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LexingtonUnited StatesUnknown status
Local Institution - 0099
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MadisonUnited StatesUnknown status
Local Institution - 0029
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MariettaUnited StatesUnknown status
Local Institution - 0098
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MineolaUnited StatesUnknown status
Local Institution - 0047
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PittsburghUnited StatesUnknown status
Local Institution - 0093
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PittsburghUnited StatesUnknown status
Local Institution - 0044
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PlainvilleUnited StatesUnknown status
Southwest Regional Cancer Clinic
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St. GeorgeUnited StatesUnknown status
Local Institution - 0091
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WichitaUnited StatesUnknown status

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