Trial Title:
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
NCT ID:
NCT04025879
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Docetaxel
Carboplatin
Nivolumab
Pemetrexed
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Biological
Intervention name:
Nivolumab
Description:
Specified dose on specified days
Arm group label:
Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
Other name:
Opdivo, BMS936558
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Specified dose on specified days
Arm group label:
Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
Arm group label:
Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Specified dose on specified days
Arm group label:
Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
Arm group label:
Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Specified dose on specified days
Arm group label:
Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
Arm group label:
Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Specified dose on specified days
Arm group label:
Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
Arm group label:
Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
Intervention type:
Drug
Intervention name:
Placebo
Description:
Specified dose on specified days
Arm group label:
Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Specified dose on specified days
Arm group label:
Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
Arm group label:
Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Local Institution - 0104
Address:
City:
Tampa
Zip:
33612
Country:
United States
Facility:
Name:
Local Institution - 0040
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Facility:
Name:
Local Institution - 0120
Address:
City:
Augusta
Zip:
30912
Country:
United States
Facility:
Name:
Local Institution - 0145
Address:
City:
Chicago
Zip:
60611
Country:
United States
Facility:
Name:
Local Institution - 0078
Address:
City:
Chicago
Zip:
60612
Country:
United States
Facility:
Name:
Local Institution - 0121
Address:
City:
Orland Park
Zip:
60462
Country:
United States
Facility:
Name:
Rcca Md Llc
Address:
City:
Bethesda
Zip:
20817
Country:
United States
Facility:
Name:
Local Institution - 0074
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Local Institution - 0076
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Local Institution - 0086
Address:
City:
Traverse City
Zip:
49684
Country:
United States
Facility:
Name:
Local Institution - 0100
Address:
City:
Lebanon
Zip:
03756
Country:
United States
Facility:
Name:
Local Institution - 0055
Address:
City:
Cincinnati
Zip:
45220
Country:
United States
Facility:
Name:
Local Institution - 0102
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Facility:
Name:
Local Institution - 0054
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Local Institution - 0103
Address:
City:
Fredericksburg
Zip:
22408
Country:
United States
Facility:
Name:
Local Institution - 0032
Address:
City:
Ciudad Autonoma Beunos Aires
Zip:
1431
Country:
Argentina
Facility:
Name:
Local Institution - 0031
Address:
City:
ABB
Zip:
C1199ABB
Country:
Argentina
Facility:
Name:
Local Institution - 0043
Address:
City:
Buenos Aires
Zip:
CP1280AEB
Country:
Argentina
Facility:
Name:
Local Institution - 0030
Address:
City:
Caba
Zip:
1426
Country:
Argentina
Facility:
Name:
Local Institution - 0020
Address:
City:
Sydney
Zip:
2050
Country:
Australia
Facility:
Name:
Local Institution - 0033
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Facility:
Name:
Local Institution - 0122
Address:
City:
Melbourne
Zip:
3065
Country:
Australia
Facility:
Name:
Local Institution - 0023
Address:
City:
North Ballarat
Zip:
33500
Country:
Australia
Facility:
Name:
Local Institution - 0002
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Facility:
Name:
Local Institution - 0005
Address:
City:
Liege
Zip:
4000
Country:
Belgium
Facility:
Name:
Local Institution - 0001
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Facility:
Name:
Local Institution - 0035
Address:
City:
Belo Horizonte
Zip:
30130-090
Country:
Brazil
Facility:
Name:
Local Institution - 0029
Address:
City:
Ijui
Zip:
98700-000
Country:
Brazil
Facility:
Name:
Local Institution - 0034
Address:
City:
São Paulo
Zip:
05652-900
Country:
Brazil
Facility:
Name:
Local Institution - 0036
Address:
City:
Sao Paulo
Zip:
01509-010
Country:
Brazil
Facility:
Name:
Local Institution - 0106
Address:
City:
São Paulo
Zip:
01321-001
Country:
Brazil
Facility:
Name:
Local Institution - 0062
Address:
City:
Oshawa
Zip:
L1G 2B9
Country:
Canada
Facility:
Name:
Local Institution - 0115
Address:
City:
Beijing
Zip:
100021
Country:
China
Facility:
Name:
Local Institution - 0096
Address:
City:
Beijing
Zip:
100142
Country:
China
Facility:
Name:
Local Institution - 0137
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Facility:
Name:
Local Institution - 0136
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Facility:
Name:
Local Institution - 0151
Address:
City:
Hubei Sheng
Zip:
430079
Country:
China
Facility:
Name:
Local Institution - 0092
Address:
City:
Changsha
Zip:
410000
Country:
China
Facility:
Name:
Local Institution - 0093
Address:
City:
Changsha
Zip:
410000
Country:
China
Facility:
Name:
Local Institution - 0091
Address:
City:
Changsha
Zip:
410008
Country:
China
Facility:
Name:
Local Institution - 0098
Address:
City:
Shanghai
Zip:
200010
Country:
China
Facility:
Name:
Local Institution - 0165
Address:
City:
Shanghai
Zip:
200030
Country:
China
Facility:
Name:
Local Institution - 0113
Address:
City:
Shanghai
Zip:
200433
Country:
China
Facility:
Name:
Local Institution - 0088
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Local Institution - 0099
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Facility:
Name:
Local Institution - 0095
Address:
City:
Shanghai
Zip:
200032
Country:
China
Facility:
Name:
Local Institution - 0041
Address:
City:
Praha 2
Zip:
128 08
Country:
Czechia
Facility:
Name:
Local Institution - 0042
Address:
City:
Praha 4
Zip:
140 59
Country:
Czechia
Facility:
Name:
Local Institution - 0073
Address:
City:
Besancon
Zip:
25030
Country:
France
Facility:
Name:
Local Institution - 0037
Address:
City:
La Tronche
Zip:
38700
Country:
France
Facility:
Name:
Local Institution - 0050
Address:
City:
Montpellier
Zip:
34295
Country:
France
Facility:
Name:
Local Institution - 0038
Address:
City:
Paris Cedex 18
Zip:
75018
Country:
France
Facility:
Name:
Local Institution - 0051
Address:
City:
Paris Cedex 20
Zip:
75970
Country:
France
Facility:
Name:
Local Institution - 0083
Address:
City:
Rennes Cedex 9
Zip:
35033
Country:
France
Facility:
Name:
Local Institution - 0146
Address:
City:
Rouen
Zip:
76000
Country:
France
Facility:
Name:
Local Institution - 0110
Address:
City:
Köln
Zip:
51109
Country:
Germany
Facility:
Name:
Local Institution - 0085
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Facility:
Name:
Local Institution - 0065
Address:
City:
Frankfurt
Zip:
60488
Country:
Germany
Facility:
Name:
Local Institution - 0072
Address:
City:
Georgsmarienhuette
Zip:
49124
Country:
Germany
Facility:
Name:
Local Institution - 0071
Address:
City:
Hamm
Zip:
59063
Country:
Germany
Facility:
Name:
Local Institution - 0108
Address:
City:
Heidelberg
Zip:
69126
Country:
Germany
Facility:
Name:
Local Institution - 0109
Address:
City:
Immenstadt
Zip:
87509
Country:
Germany
Facility:
Name:
Local Institution - 0064
Address:
City:
Loewenstein
Zip:
74245
Country:
Germany
Facility:
Name:
Local Institution - 0147
Address:
City:
Ludwigsburg
Zip:
71640
Country:
Germany
Facility:
Name:
Local Institution - 0063
Address:
City:
Luebeck
Zip:
23538
Country:
Germany
Facility:
Name:
Local Institution - 0070
Address:
City:
Moers
Zip:
47441
Country:
Germany
Facility:
Name:
Local Institution - 0066
Address:
City:
Muenchen
Zip:
81675
Country:
Germany
Facility:
Name:
Local Institution - 0016
Address:
City:
Dublin
Zip:
D24 DH74
Country:
Ireland
Facility:
Name:
Local Institution - 0024
Address:
City:
Forlì
Zip:
47014
Country:
Italy
Facility:
Name:
Local Institution - 0026
Address:
City:
Milano
Zip:
20122
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Di Parma
Address:
City:
Parma
Zip:
43126
Country:
Italy
Facility:
Name:
Local Institution - 0135
Address:
City:
Nagoya-shi
Zip:
4640021
Country:
Japan
Facility:
Name:
Local Institution - 0124
Address:
City:
Kashiwa-shi
Zip:
2778577
Country:
Japan
Facility:
Name:
Local Institution - 0129
Address:
City:
Kitakyushu-shi
Zip:
8078556
Country:
Japan
Facility:
Name:
Local Institution - 0127
Address:
City:
Kobe-shi
Zip:
6500047
Country:
Japan
Facility:
Name:
Local Institution - 0144
Address:
City:
Kanazawa-shi
Zip:
9208641
Country:
Japan
Facility:
Name:
Local Institution - 0125
Address:
City:
Yokohama
Zip:
241-8515
Country:
Japan
Facility:
Name:
Local Institution - 0131
Address:
City:
Sendai-shi
Zip:
9800873
Country:
Japan
Facility:
Name:
Local Institution - 0126
Address:
City:
Sakai-shi
Zip:
5918555
Country:
Japan
Facility:
Name:
Local Institution - 0130
Address:
City:
Kitaadachigun
Zip:
3620806
Country:
Japan
Facility:
Name:
Local Institution - 0142
Address:
City:
Bunkyo-ku
Zip:
1138431
Country:
Japan
Facility:
Name:
Local Institution - 0133
Address:
City:
Bunkyo-ku
Zip:
1138603
Country:
Japan
Facility:
Name:
Local Institution - 0143
Address:
City:
Chuo-ku
Zip:
1040045
Country:
Japan
Facility:
Name:
Local Institution - 0134
Address:
City:
Chuo-ku
Zip:
5418567
Country:
Japan
Facility:
Name:
Local Institution - 0132
Address:
City:
Fukushima-shi
Zip:
960-1295
Country:
Japan
Facility:
Name:
Local Institution - 0128
Address:
City:
Hiroshima
Zip:
734-8551
Country:
Japan
Facility:
Name:
Local Institution - 0077
Address:
City:
Guadalajara
Zip:
44280
Country:
Mexico
Facility:
Name:
Local Institution - 0027
Address:
City:
Monterrey
Zip:
64460
Country:
Mexico
Facility:
Name:
Local Institution - 0028
Address:
City:
Chihuahua
Zip:
31000
Country:
Mexico
Facility:
Name:
Local Institution - 0004
Address:
City:
Groningen
Zip:
9700RB
Country:
Netherlands
Facility:
Name:
Local Institution - 0003
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Facility:
Name:
Local Institution - 0049
Address:
City:
Kraków
Zip:
31-202
Country:
Poland
Facility:
Name:
Local Institution - 0117
Address:
City:
Hato Rey
Zip:
00917
Country:
Puerto Rico
Facility:
Name:
Local Institution - 0013
Address:
City:
Cluj-Napoca
Zip:
400015
Country:
Romania
Facility:
Name:
Local Institution - 0011
Address:
City:
Bucuresti
Zip:
022328
Country:
Romania
Facility:
Name:
Local Institution - 0012
Address:
City:
Floresti
Zip:
407280
Country:
Romania
Facility:
Name:
Local Institution
Address:
City:
Moscow
Zip:
115478
Country:
Russian Federation
Facility:
Name:
Local Institution
Address:
City:
Saint-Petersburg
Zip:
197758
Country:
Russian Federation
Facility:
Name:
Local Institution
Address:
City:
St. Petersburg
Zip:
194291
Country:
Russian Federation
Facility:
Name:
Local Institution
Address:
City:
St. Petersburg
Zip:
198255
Country:
Russian Federation
Facility:
Name:
Local Institution - 0046
Address:
City:
Madrid
Zip:
28006
Country:
Spain
Facility:
Name:
Local Institution - 0044
Address:
City:
Majadahonda - Madrid
Zip:
28222
Country:
Spain
Facility:
Name:
Local Institution - 0045
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Facility:
Name:
Local Institution - 0149
Address:
City:
Kaohsiung City
Zip:
807
Country:
Taiwan
Facility:
Name:
Local Institution - 0119
Address:
City:
Kaohsiung
Zip:
833
Country:
Taiwan
Facility:
Name:
Local Institution - 0116
Address:
City:
New Taipei City
Zip:
235
Country:
Taiwan
Facility:
Name:
Local Institution - 0112
Address:
City:
Taipei City
Zip:
100225
Country:
Taiwan
Facility:
Name:
Local Institution - 0007
Address:
City:
Taunton
Zip:
TA1 5DA
Country:
United Kingdom
Start date:
November 5, 2019
Completion date:
July 30, 2027
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04025879
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT04025879.html
