Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
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
Verified date | April 2024 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 482 |
Est. completion date | September 30, 2024 |
Est. primary completion date | July 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Argentina | Local Institution - 0031 | ABB | Ciudad Autónoma De Buenos Aires |
Argentina | Local Institution - 0043 | Buenos Aires | |
Argentina | Local Institution - 0030 | Caba | |
Argentina | Local Institution - 0032 | Ciudad Autonoma Beunos Aires | Buenos Aires |
Australia | Local Institution - 0033 | Heidelberg | Victoria |
Australia | Local Institution - 0122 | Melbourne | Victoria |
Australia | Local Institution - 0023 | North Ballarat | Victoria |
Australia | Local Institution - 0020 | Sydney | New South Wales |
Belgium | Local Institution - 0002 | Edegem | |
Belgium | Local Institution - 0005 | Liege | |
Belgium | Local Institution - 0001 | Roeselare | |
Brazil | Local Institution - 0035 | Belo Horizonte | Minas Gerais |
Brazil | Local Institution - 0029 | Ijui | RIO Grande DO SUL |
Brazil | Local Institution - 0036 | Sao Paulo | São Paulo |
Brazil | Local Institution - 0034 | São Paulo | SAO Paulo |
Brazil | Local Institution - 0106 | São Paulo | |
Canada | Local Institution - 0062 | Oshawa | Ontario |
China | Local Institution - 0096 | Beijing | BEI |
China | Local Institution - 0115 | Beijing | Beijing |
China | Local Institution - 0091 | Changsha | Hunan |
China | Local Institution - 0092 | Changsha | Hunan |
China | Local Institution - 0093 | Changsha | Hunan |
China | Local Institution - 0088 | Chengdu | Sichuan |
China | Local Institution - 0136 | Fuzhou | Fujian |
China | Local Institution - 0137 | Fuzhou | Fujian |
China | Local Institution - 0099 | Hangzhou | Zhejiang |
China | Local Institution - 0151 | Hubei Sheng | Hubei |
China | Local Institution - 0095 | Shanghai | |
China | Local Institution - 0098 | Shanghai | Shanghai |
China | Local Institution - 0113 | Shanghai | Shanghai |
China | Local Institution - 0165 | Shanghai | Shanghai |
Czechia | Local Institution - 0041 | Praha 2 | |
Czechia | Local Institution - 0042 | Praha 4 | |
France | Local Institution - 0073 | Besancon | |
France | Local Institution - 0037 | La Tronche | |
France | Local Institution - 0050 | Montpellier | |
France | Local Institution - 0038 | Paris Cedex 18 | |
France | Local Institution - 0051 | Paris Cedex 20 | |
France | Local Institution - 0083 | Rennes Cedex 9 | |
France | Local Institution - 0146 | Rouen | |
Germany | Local Institution - 0085 | Berlin | |
Germany | Local Institution - 0065 | Frankfurt | |
Germany | Local Institution - 0072 | Georgsmarienhuette | |
Germany | Local Institution - 0071 | Hamm | |
Germany | Local Institution - 0108 | Heidelberg | |
Germany | Local Institution - 0109 | Immenstadt | |
Germany | Local Institution - 0110 | Köln | Nordrhein-Westfalen |
Germany | Local Institution - 0064 | Loewenstein | |
Germany | Local Institution - 0147 | Ludwigsburg | |
Germany | Local Institution - 0063 | Luebeck | |
Germany | Local Institution - 0070 | Moers | |
Germany | Local Institution - 0066 | Muenchen | |
Ireland | Local Institution - 0016 | Dublin | |
Italy | Local Institution - 0024 | Forlì | |
Italy | Local Institution - 0026 | Milano | |
Italy | Azienda Ospedaliera Di Parma | Parma | |
Japan | Local Institution - 0133 | Bunkyo-ku | Tokyo |
Japan | Local Institution - 0142 | Bunkyo-ku | Tokyo |
Japan | Local Institution - 0134 | Chuo-ku | Tokyo |
Japan | Local Institution - 0143 | Chuo-ku | Tokyo |
Japan | Local Institution - 0132 | Fukushima-shi | |
Japan | Local Institution - 0128 | Hiroshima | |
Japan | Local Institution - 0144 | Kanazawa-shi | Ishikawa |
Japan | Local Institution - 0124 | Kashiwa-shi | Chiba |
Japan | Local Institution - 0130 | Kitaadachigun | Saitama |
Japan | Local Institution - 0129 | Kitakyushu-shi | Fukuoka |
Japan | Local Institution - 0127 | Kobe-shi | Hyogo |
Japan | Local Institution - 0135 | Nagoya-shi | Aichi |
Japan | Local Institution - 0126 | Sakai-shi | Osaka |
Japan | Local Institution - 0131 | Sendai-shi | Miyagi |
Japan | Local Institution - 0125 | Yokohama | Kanagawa |
Mexico | Local Institution - 0028 | Chihuahua | |
Mexico | Local Institution - 0077 | Guadalajara | Jalisco |
Mexico | Local Institution - 0027 | Monterrey | Nuevo Leon |
Netherlands | Local Institution - 0004 | Groningen | |
Netherlands | Local Institution - 0003 | Rotterdam | |
Poland | Local Institution - 0049 | Kraków | Malopolskie |
Puerto Rico | Local Institution - 0117 | Hato Rey | |
Romania | Local Institution - 0011 | Bucuresti | |
Romania | Local Institution - 0013 | Cluj-Napoca | Cluj |
Romania | Local Institution - 0012 | Floresti | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Saint-Petersburg | |
Russian Federation | Local Institution | St. Petersburg | |
Russian Federation | Local Institution | St. Petersburg | |
Spain | Local Institution - 0046 | Madrid | |
Spain | Local Institution - 0044 | Majadahonda - Madrid | |
Spain | Local Institution - 0045 | Valencia | |
Taiwan | Local Institution - 0119 | Kaohsiung | |
Taiwan | Local Institution - 0149 | Kaohsiung City | |
Taiwan | Local Institution - 0116 | New Taipei City | |
Taiwan | Local Institution - 0112 | Taipei City | |
United Kingdom | Local Institution - 0007 | Taunton | |
United States | Local Institution - 0040 | Atlanta | Georgia |
United States | Local Institution - 0120 | Augusta | Georgia |
United States | Rcca Md Llc | Bethesda | Maryland |
United States | Local Institution - 0074 | Boston | Massachusetts |
United States | Local Institution - 0076 | Boston | Massachusetts |
United States | Local Institution - 0078 | Chicago | Illinois |
United States | Local Institution - 0145 | Chicago | Illinois |
United States | Local Institution - 0055 | Cincinnati | Ohio |
United States | Local Institution - 0102 | Cleveland | Ohio |
United States | Local Institution - 0103 | Fredericksburg | Virginia |
United States | Local Institution - 0054 | Houston | Texas |
United States | Local Institution - 0100 | Lebanon | New Hampshire |
United States | Local Institution - 0121 | Orland Park | Illinois |
United States | Local Institution - 0104 | Tampa | Florida |
United States | Local Institution - 0086 | Traverse City | Michigan |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR) | 5 Years from randomization | ||
Secondary | Overall Survival (OS) | Up to 5 years from randomization | ||
Secondary | Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR) | At the time of surgery, between week 12 to week 18 | ||
Secondary | Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review | Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22 | ||
Secondary | Incidence of Serious Adverse Events (SAEs) | Up to 80 weeks | ||
Secondary | Incidence of Adverse Events (AEs) | Up to 80 weeks |
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