NCT04025879Active, not recruitingPhase 3
A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 461 (actual)
- First submitted
- 17 Jul 2019
- Start date
- 5 Nov 2019
- Primary completion date
- 26 Jul 2023
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Lung cancer
- NCT number
- NCT04025879
- EU CT number
- 2022-502658-15-00
- EudraCT number
- 2019-000262-38
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 461
- From 5 Nov 2019 to the primary completion date, 26 Jul 2023
- 105 sites in 22 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
- Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
- Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Other protocol-defined inclusion/exclusion criteria apply
Other illness
- Participants with an active, known or suspected autoimmune disease
- Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
Who the study is looking for
- Participants with suspected or histologically confirmed Stage IIA (\> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
- No brain metastasis
- Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
- Ability to provide surgical or biopsy tumor tissue for biomarkers
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (105)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0031 Coordinator of this site? Confirm its status | ABB | Argentina | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Ciudad Autonoma Beunos Aires | Argentina | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Local Institution - 0122 Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Local Institution - 0023 Coordinator of this site? Confirm its status | North Ballarat | Australia | Unknown status |
| Local Institution - 0020 Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Active, not recruiting |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Active, not recruiting |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Local Institution - 0106 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0036 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0034 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0062 Coordinator of this site? Confirm its status | Oshawa | Canada | Unknown status |
| Local Institution - 0096 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0115 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0091 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0092 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0088 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Local Institution - 0136 Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Local Institution - 0137 Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Local Institution - 0099 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0151 Coordinator of this site? Confirm its status | Hubei Sheng | China | Unknown status |
| Local Institution - 0113 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0098 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0165 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague 4 | Czechia | Active, not recruiting |
| Charite Universitatsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Kliniken der Stadt Koeln gGmbH Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| Krankenhaus Nordwest GmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Active, not recruiting |
| Franziskus Hospital Harderberg Coordinator of this site? Confirm its status | Georgsmarienhuette | Germany | Active, not recruiting |
| Evangelisches Krankenhaus Hamm gGmbH Coordinator of this site? Confirm its status | Hamm | Germany | Active, not recruiting |
| Thoraxklinik At University Of Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Klinikverbund Allgau gGmbH Coordinator of this site? Confirm its status | Immenstadt I. Allgäu | Germany | Active, not recruiting |
| Klinik Loewenstein gGmbH Coordinator of this site? Confirm its status | Loewenstein | Germany | Active, not recruiting |
| University Medical Centre Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Active, not recruiting |
| RKH Klinken Ludwigsburg-Bietigheim gGmbH Coordinator of this site? Confirm its status | Ludwigsburg | Germany | Active, not recruiting |
| Krankenhaus Bethanien Coordinator of this site? Confirm its status | Moers | Germany | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Catalan Institute of Oncology Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| University Hospital Of Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Rennes Coordinator of this site? Confirm its status | Rennes Cedex 9 | France | Active, not recruiting |
| CHU De Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Taunton | United Kingdom | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori S.r.l. Coordinator of this site? Confirm its status | Meldola | Italy | Active, not recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Parma Coordinator of this site? Confirm its status | Parma | Italy | Active, not recruiting |
| Local Institution - 0142 Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| Local Institution - 0133 Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| Local Institution - 0134 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Local Institution - 0143 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Local Institution - 0132 Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| Local Institution - 0128 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Local Institution - 0144 Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Local Institution - 0124 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Local Institution - 0130 Coordinator of this site? Confirm its status | Kitaadachigun | Japan | Unknown status |
| Local Institution - 0129 Coordinator of this site? Confirm its status | Kitakyushu-shi | Japan | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Local Institution - 0135 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Local Institution - 0126 Coordinator of this site? Confirm its status | Sakai-shi | Japan | Unknown status |
| Local Institution - 0131 Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Local Institution - 0125 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Krakowski Szpital Specjalistyczny im. Jana Pawła II Coordinator of this site? Confirm its status | Kraków | Poland | Active, not recruiting |
| Local Institution - 0117 Coordinator of this site? Confirm its status | Hato Rey | Puerto Rico | Unknown status |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Active, not recruiting |
| Radiotherapy Center Cluj S.R.L. Coordinator of this site? Confirm its status | Floresti | Romania | Active, not recruiting |
| 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 |
| Local Institution - 0149 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Local Institution - 0119 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Local Institution - 0116 Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Local Institution - 0112 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0040 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Local Institution - 0120 Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Rcca Md Llc Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Local Institution - 0076 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0078 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Local Institution - 0145 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Local Institution - 0055 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Local Institution - 0102 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 0103 Coordinator of this site? Confirm its status | Fredericksburg | United States | Unknown status |
| Local Institution - 0054 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Local Institution - 0100 Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| Local Institution - 0074 Coordinator of this site? Confirm its status | Newton | United States | Unknown status |
| Local Institution - 0121 Coordinator of this site? Confirm its status | Orland Park | United States | Unknown status |
| Local Institution - 0104 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Local Institution - 0086 Coordinator of this site? Confirm its status | Traverse City | United States | Unknown status |
Related publications
- Biomarkers of nivolumab benefit in resectable non-small cell lung cancer.Nature · 2026 · PMID 42587156
- Clinical outcomes with perioperative nivolumab by nodal status in patients with stage III resectable NSCLC: phase 3 CheckMate 77T exploratory analysis.Nat Cancer · 2026 · PMID 41507539
- Perioperative Nivolumab in Resectable Non-Small Cell Lung Cancer: A Subanalysis of Japanese Patients From CheckMate 77T.Cancer Sci · 2026 · PMID 41431434
This page is information, not medical advice. Discuss any trial with your doctor.