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
Sites (106)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0014 Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Río Cuarto | Argentina | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Local Institution - 0026 Coordinator of this site? Confirm its status | Viedma | Argentina | Unknown status |
| Local Institution - 0040 Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| Local Institution - 0089 Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| Local Institution - 0086 Coordinator of this site? Confirm its status | Gosford | Australia | Unknown status |
| Local Institution - 0036 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Local Institution - 0078 Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Completed |
| Local Institution - 0064 Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Local Institution - 0069 Coordinator of this site? Confirm its status | Blumenau | Brazil | Unknown status |
| Local Institution - 0063 Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Local Institution - 0068 Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| Local Institution - 0067 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Local Institution - 0066 Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Local Institution - 0065 Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Local Institution - 0070 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0082 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0090 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0083 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0080 Coordinator of this site? Confirm its status | Rimouski | Canada | Unknown status |
| Local Institution - 0084 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0059 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Local Institution - 0139 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0113 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0106 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0144 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0146 Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Local Institution - 0110 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0112 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0108 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Local Institution - 0111 Coordinator of this site? Confirm its status | Zhejiang | China | Unknown status |
| Local Institution - 0148 Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Local Institution - 0120 Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Helios Klinikum Emil von Behring GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Asklepios Fachkliniken Muenchen-Gauting Coordinator of this site? Confirm its status | Gauting | Germany | Completed |
| LungenClinic Grosshansdorf GmbH Coordinator of this site? Confirm its status | Grosshansdorf | Germany | Completed |
| Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Coordinator of this site? Confirm its status | Hemer | Germany | Completed |
| Robert Bosch Krankenhaus GmbH Coordinator of this site? Confirm its status | Stuttgart | Germany | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Centre Hospitalier Universitaire de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Completed |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Completed |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| Local Institution - 0049 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0048 Coordinator of this site? Confirm its status | Tauton | United Kingdom | Unknown status |
| University Hospital Limerick Coordinator of this site? Confirm its status | Limerick | Ireland | Completed |
| Local Institution - 0042 Coordinator of this site? Confirm its status | Lucca | Italy | Unknown status |
| Local Institution - 0041 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Local Institution - 0131 Coordinator of this site? Confirm its status | Akashi-shi | Japan | Unknown status |
| Local Institution - 0101 Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| Local Institution - 0135 Coordinator of this site? Confirm its status | Habikino-shi | Japan | Unknown status |
| Local Institution - 0119 Coordinator of this site? Confirm its status | Himeji-shi | Japan | Unknown status |
| Local Institution - 0138 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Local Institution - 0137 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Local Institution - 0115 Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Local Institution - 0102 Coordinator of this site? Confirm its status | Kitaadachi-gun | Japan | Unknown status |
| Local Institution - 0104 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Local Institution - 0118 Coordinator of this site? Confirm its status | Maebashi | Japan | Unknown status |
| Local Institution - 0116 Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Local Institution - 0136 Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Local Institution - 0130 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Local Institution - 0103 Coordinator of this site? Confirm its status | Ōsaka-sayama | Japan | Unknown status |
| Local Institution - 0128 Coordinator of this site? Confirm its status | Ota-shi | Japan | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0100 Coordinator of this site? Confirm its status | Shiwa-gun | Japan | Unknown status |
| Local Institution - 0132 Coordinator of this site? Confirm its status | Ube-shi | Japan | Unknown status |
| Local Institution - 0134 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0114 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0129 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0061 Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | La Paz | Mexico | Unknown status |
| Local Institution - 0075 Coordinator of this site? Confirm its status | Veracruz, Veracruz | Mexico | Unknown status |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Local Institution - 0024 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution - 0025 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Local Institution - 0094 Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Memorial Health Systems Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Local Institution - 0105 Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Local Institution - 0045 Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Local Institution - 0058 Coordinator of this site? Confirm its status | Johnson City | United States | Unknown status |
| Local Institution - 0006 Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| Local Institution - 0004 Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Local Institution - 0099 Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Local Institution - 0098 Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| Local Institution - 0047 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Local Institution - 0044 Coordinator of this site? Confirm its status | Plainville | United States | Unknown status |
| Southwest Regional Cancer Clinic Coordinator of this site? Confirm its status | St. George | United States | Unknown status |
| Local Institution - 0091 Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
Related publications
- Nivolumab plus ipilimumab-based treatment in Japanese patients with metastatic non-small cell lung cancer and tumor PD-L1 < 1%: a pooled analysis.Int J Clin Oncol · 2026 · PMID 42579028
This page is information, not medical advice. Discuss any trial with your doctor.