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Active (not recruiting) Phase 3 NCT04025879

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

Phase 3 – large-scale trial before approval
Conditions: Carcinoma, Non-Small-Cell Lung

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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
Locations 22
Argentina (1)
Local Institution - 0032
Ciudad Autonoma Beunos Aires , Buenos Aires
Australia (1)
Local Institution - 0020
Sydney , New South Wales
Belgium (1)
Local Institution - 0002
Edegem
Brazil (1)
Local Institution - 0035
Belo Horizonte , Minas Gerais
Canada (1)
Local Institution - 0062
Oshawa , Ontario
China (1)
Local Institution - 0115
Beijing , Beijing Municipality
Czech Republic (1)
Local Institution - 0041
Prague
France (1)
Local Institution - 0073
Besançon
Germany (1)
Local Institution - 0109
Immenstadt im Allgäu , Bavaria
Ireland (1)
Local Institution - 0016
Dublin
Italy (1)
Local Institution - 0024
Forlì
Japan (1)
Local Institution - 0135
Nagoya , Aichi-ken
Mexico (1)
Local Institution - 0077
Guadalajara , Jalisco
Netherlands (1)
Local Institution - 0004
Groningen
Poland (1)
Local Institution - 0049
Krakow , Lesser Poland Voivodeship
Puerto Rico (1)
Local Institution - 0117
Hato Rey
Romania (1)
Local Institution - 0013
Cluj-Napoca , Cluj
Russia (1)
Local Institution
Moscow
Spain (1)
Local Institution - 0046
Madrid
Taiwan (1)
Local Institution - 0149
Kaohsiung City
United Kingdom (1)
Local Institution - 0007
Taunton
United States (1)
Local Institution - 0104
Tampa , Florida
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
05.11.2019
Completion date
30.07.2027
Registry ID
NCT04025879
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.