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
Sites (135)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0022 Coordinator of this site? Confirm its status | Capital Federal | Argentina | Unknown status |
| Local Institution - 0023 Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aire | Argentina | Unknown status |
| Fundacao Pio Xii Hosp Cancer De Barretos Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Local Institution - 0076 Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Local Institution - 0073 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Local Institution - 0075 Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Gatineau | Canada | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0138 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Local Institution - 0156 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0161 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0175 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0192 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0193 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0178 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Local Institution - 0190 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 0182 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0189 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0183 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0166 Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Local Institution - 0179 Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Local Institution - 0165 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0160 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0163 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Local Institution - 0180 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Local Institution - 0159 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Hospital Universitari Vall d'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 Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Completed |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| Centre Hospitalier Universitaire De Rennes Coordinator of this site? Confirm its status | Rennes Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Completed |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Local Institution - 0122 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Unknown status |
| Istituto Tumori Bari Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Completed |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| University Hospital Of Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Completed |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Completed |
| Local Institution - 0126 Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| Local Institution - 0110 Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| Local Institution - 0109 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Local Institution - 0118 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Local Institution - 0111 Coordinator of this site? Confirm its status | Kitakyushu-shi | Japan | Unknown status |
| Local Institution - 0133 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Local Institution - 0131 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Local Institution - 0108 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Local Institution - 0119 Coordinator of this site? Confirm its status | Sakai-shi | Japan | Unknown status |
| Local Institution - 0147 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0148 Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Local Institution - 0120 Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Local Institution - 0132 Coordinator of this site? Confirm its status | Sunto-gun | Japan | Unknown status |
| Local Institution - 0124 Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Local Institution - 0123 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0097 Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Local Institution - 0098 Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Local Institution - 0105 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Local Institution - 0102 Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Local Institution - 0107 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Local Institution - 0099 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0100 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Local Institution - 0151 Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Texas Oncology Coordinator of this site? Confirm its status | Bedford | United States | Unknown status |
| St. Vincent Frontier Cancer Center Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| Local Institution - 0008 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0135 Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Local Institution - 0021 Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Local Institution - 0015 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| MetroHealth Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 0025 Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Local Institution - 0125 Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Southcoast Center For Cancer Coordinator of this site? Confirm its status | Fairhaven | United States | Unknown status |
| Local Institution - 0153 Coordinator of this site? Confirm its status | Fort Bliss | United States | Unknown status |
| Local Institution - 0171 Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Local Institution - 0198 Coordinator of this site? Confirm its status | Fredericksburg | United States | Unknown status |
| Local Institution - 0121 Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Local Institution - 0146 Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Local Institution - 0009 Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Local Institution - 0090 Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Local Institution - 0140 Coordinator of this site? Confirm its status | High Point | United States | Unknown status |
| Local Institution - 0173 Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Local Institution - 0106 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Local Institution - 0170 Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Local Institution - 0081 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 0186 Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Southwest Cancer Center Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Northwest Georgia Oncology Center, P.C. Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Local Institution - 0136 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Intermountain Medical Center Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Local Institution - 0092 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| University Medical Center New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Local Institution - 0006 Coordinator of this site? Confirm its status | Newton | United States | Unknown status |
| Local Institution - 0011 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Illinois Cancer Specialists Coordinator of this site? Confirm its status | Niles | United States | Unknown status |
| Local Institution - 0054 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Orlando Health, Inc. Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Local Institution - 0018 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Plainville | United States | Unknown status |
| Local Institution - 0139 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Kaiser Permanente Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Texas Cancer Center - Sherman Coordinator of this site? Confirm its status | Sherman | United States | Unknown status |
| Southwest Regional Cancer Clinic Coordinator of this site? Confirm its status | St. George | United States | Unknown status |
| Local Institution - 0143 Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| Indian River Medical Center Coordinator of this site? Confirm its status | Vero Beach | United States | Unknown status |
| Local Institution - 0026 Coordinator of this site? Confirm its status | Waco | United States | Unknown status |
| Valley Hospital Luckow Pavili Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
| Local Institution - 0149 Coordinator of this site? Confirm its status | Zanesville | United States | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Local Institution - 0084 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Local Institution - 0115 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.