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Активно (без набиране) Фаза 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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Carcinoma, Non-Small-Cell Lung

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Места на провеждане 22
Argentina (1)
Local Institution - 0032
Ciudad Autonoma Beunos Aires , Buenos Aires
Австралия (1)
Local Institution - 0020
Sydney , New South Wales
Белгия (1)
Local Institution - 0002
Edegem
Бразилия (1)
Local Institution - 0035
Belo Horizonte , Minas Gerais
Канада (1)
Local Institution - 0062
Oshawa , Ontario
Китай (1)
Local Institution - 0115
Beijing , Beijing Municipality
Чехия (1)
Local Institution - 0041
Prague
Франция (1)
Local Institution - 0073
Besançon
Германия (1)
Local Institution - 0109
Immenstadt im Allgäu , Bavaria
Ireland (1)
Local Institution - 0016
Dublin
Италия (1)
Local Institution - 0024
Forlì
Япония (1)
Local Institution - 0135
Nagoya , Aichi-ken
Mexico (1)
Local Institution - 0077
Guadalajara , Jalisco
Нидерландия (1)
Local Institution - 0004
Groningen
Полша (1)
Local Institution - 0049
Krakow , Lesser Poland Voivodeship
Puerto Rico (1)
Local Institution - 0117
Hato Rey
Румъния (1)
Local Institution - 0013
Cluj-Napoca , Cluj
Russia (1)
Local Institution
Moscow
Испания (1)
Local Institution - 0046
Madrid
Taiwan (1)
Local Institution - 0149
Kaohsiung City
Великобритания (1)
Local Institution - 0007
Taunton
САЩ (1)
Local Institution - 0104
Tampa , Florida
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
05.11.2019
Крайна дата
30.07.2027
Регистрационен номер
NCT04025879
Източник
anzctr
Запитване за медицински туризъм

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