NCT04026412CompletedPhase 3
A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
Source: ClinicalTrials.gov · Last updated 24 Jul 2025
Brief summary (registry, in English)
The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 925 (actual)
- First submitted
- 18 Jul 2019
- Start date
- 8 Oct 2019
- Primary completion date
- 22 Mar 2024
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Lung cancer
- NCT number
- NCT04026412
- EU CT number
- 2022-502886-71-00
- EudraCT number
- 2019-001222-98
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 925
- From 8 Oct 2019 to the primary completion date, 22 Mar 2024
- 168 sites in 27 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
- Active infection requiring systemic therapy within 14 days prior to randomization
- Prior thoracic radiotherapy
- Other protocol-defined inclusion/exclusion criteria apply
Other illness
- Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
- History of organ or tissue transplant that requires systemic use of immune suppressive agents
Who the study is looking for
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
- Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (168)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0043 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0042 Coordinator of this site? Confirm its status | Caba | Argentina | Unknown status |
| Local Institution - 0044 Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Local Institution - 0045 Coordinator of this site? Confirm its status | Río Cuarto | Argentina | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Local Institution - 0224 Coordinator of this site? Confirm its status | Ballarat Central | Australia | Unknown status |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Local Institution - 0134 Coordinator of this site? Confirm its status | Gosford | Australia | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Greenslopes | Australia | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Kingswood | Australia | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| UCL Mont-Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Completed |
| Local Institution - 0036 Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Blumenau | Brazil | Unknown status |
| Local Institution - 0234 Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Local Institution - 0038 Coordinator of this site? Confirm its status | Ipatinga | Brazil | Unknown status |
| Local Institution - 0034 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Local Institution - 0237 Coordinator of this site? Confirm its status | Chicoutimi | Canada | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Local Institution - 0078 Coordinator of this site? Confirm its status | Oshawa | Canada | Unknown status |
| Local Institution - 0126 Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Local Institution - 0070 Coordinator of this site? Confirm its status | Rimouski | Canada | Unknown status |
| Local Institution - 0092 Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Local Institution - 0057 Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Local Institution - 0058 Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Local Institution - 0059 Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| Local Institution - 0056 Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Local Institution - 0041 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0040 Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Local Institution - 0146 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0170 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0183 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0154 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0186 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Local Institution - 0189 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Local Institution - 0149 Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Local Institution - 0179 Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Local Institution - 0180 Coordinator of this site? Confirm its status | Gongzhuling | China | Unknown status |
| Local Institution - 0192 Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Local Institution - 0140 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0147 Coordinator of this site? Confirm its status | Hankou | China | Unknown status |
| Local Institution - 0138 Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Local Institution - 0184 Coordinator of this site? Confirm its status | Linhai | China | Unknown status |
| Local Institution - 0178 Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Local Institution - 0139 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Local Institution - 0145 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0150 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Local Institution - 0148 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Local Institution - 0164 Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Helios Klinikum Emil von Behring GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| LungenClinic Grosshansdorf GmbH Coordinator of this site? Confirm its status | Großhansdorf | Germany | Completed |
| Evangelisches Krankenhaus Hamm gGmbH Coordinator of this site? Confirm its status | Hamm | Germany | Completed |
| Thoraxklinik At University Of Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Lungenfachklinik Immenhausen Coordinator of this site? Confirm its status | Immenhausen | Germany | Completed |
| Klinikverbund Allgau gGmbH Coordinator of this site? Confirm its status | Kempten (Allgau) | Germany | Completed |
| SLK-Kliniken GmbH - Standort Fachklinik Löwenstein Coordinator of this site? Confirm its status | Löwenstein | Germany | Completed |
| Universitatsmedizin der Johannes Gutenberg-Universitat Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Robert Bosch Krankenhaus GmbH Coordinator of this site? Confirm its status | Stuttgart | Germany | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Centre de Cancérologie du Grand Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | 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 Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Completed |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Completed |
| Local Institution - 0054 Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Bebington | United Kingdom | Unknown status |
| Local Institution - 0009 Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | Poole | United Kingdom | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Swansea | United Kingdom | Unknown status |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Completed |
| St Vincent's University Hospital Coordinator of this site? Confirm its status | Dublin 4 | Ireland | Completed |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Completed |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Completed |
| University Hospital Of Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Completed |
| Local Institution - 0199 Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| Local Institution - 0200 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Local Institution - 0212 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Local Institution - 0198 Coordinator of this site? Confirm its status | Hidaka-shi | Japan | Unknown status |
| Local Institution - 0203 Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Local Institution - 0174 Coordinator of this site? Confirm its status | Kitaadachi-gun | Japan | Unknown status |
| Local Institution - 0206 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Local Institution - 0211 Coordinator of this site? Confirm its status | Kurume-shi | Japan | Unknown status |
| Local Institution - 0204 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Local Institution - 0202 Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Local Institution - 0205 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Local Institution - 0197 Coordinator of this site? Confirm its status | Ōta | Japan | Unknown status |
| Local Institution - 0195 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0210 Coordinator of this site? Confirm its status | Sayama | Japan | Unknown status |
| Local Institution - 0196 Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Local Institution - 0232 Coordinator of this site? Confirm its status | Ube | Japan | Unknown status |
| Local Institution - 0175 Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| Local Institution - 0217 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0201 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0216 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0167 Coordinator of this site? Confirm its status | Cheongju-si, Chungcheonbuk-do, | South Korea | Unknown status |
| Local Institution - 0152 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0168 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0015 Coordinator of this site? Confirm its status | Culiacán | Mexico | Unknown status |
| Local Institution - 0067 Coordinator of this site? Confirm its status | Df | Mexico | Unknown status |
| Local Institution - 0080 Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | La Paz | Mexico | Unknown status |
| Local Institution - 0014 Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Stichting VUmc Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Stichting Rijnstate Ziekenhuis Coordinator of this site? Confirm its status | Arnhem | Netherlands | Completed |
| University Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Completed |
| Maxima Medisch Centrum Coordinator of this site? Confirm its status | Veldhoven | Netherlands | Completed |
| 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 |
| Provita Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Tomaszow Mazowiecki | Poland | Completed |
| Local Institution - 0120 Coordinator of this site? Confirm its status | Hato Rey | Puerto Rico | Unknown status |
| GCM Medical Group, PSC - Hato Rey Site Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Focus Lab Plus S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| 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 |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Radiotherapy Center Cluj S.R.L. Coordinator of this site? Confirm its status | Floresti | Romania | Completed |
| Local Institution Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Sahlgrenska University Hospital-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Completed |
| Local Institution - 0171 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0208 Coordinator of this site? Confirm its status | KaohsiungCity | Taiwan | Unknown status |
| Local Institution - 0214 Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Local Institution - 0209 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Local Institution - 0143 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0133 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0213 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0125 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Local Institution - 0165 Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Local Institution - 0191 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Local Institution - 0108 Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Bryan | United States | Unknown status |
| Local Institution - 0071 Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Local Institution - 0131 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Local Institution - 0188 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Local Institution - 0053 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Local Institution - 0047 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 0124 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 0112 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 0130 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 0218 Coordinator of this site? Confirm its status | Edgewood | United States | Unknown status |
| Local Institution - 0233 Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Local Institution - 0119 Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Local Institution - 0129 Coordinator of this site? Confirm its status | Lone Tree | United States | Unknown status |
| Local Institution - 0219 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Local Institution - 0039 Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Local Institution - 0166 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Local Institution - 0207 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Local Institution - 0116 Coordinator of this site? Confirm its status | Traverse City | United States | Unknown status |
| Local Institution - 0123 Coordinator of this site? Confirm its status | Youngstown | United States | Unknown status |
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