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NCT04025879 Clinical Trial

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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04025879
Other study ID # CA209-77T
Secondary ID 2019-000262-38
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 5, 2019
Est. completion date September 30, 2024

Study information
Verified date April 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Nivolumab
Specified dose on specified days
Drug:
• Carboplatin
Specified dose on specified days
• Cisplatin
Specified dose on specified days
• Paclitaxel
Specified dose on specified days
• Pemetrexed
Specified dose on specified days
• Placebo
Specified dose on specified days
• Docetaxel
Specified dose on specified days

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

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, 

Outcome
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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Active, not recruiting NCT04487080 - A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Phase 3
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Completed NCT01953913 - Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation Phase 3
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Completed NCT04427072 - Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation Phase 3
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A

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