A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Interventions
- Registration Number
- NCT04026412
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 925
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
- Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease
- Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
- Active infection requiring systemic therapy within 14 days prior to randomization
- History of organ or tissue transplant that requires systemic use of immune suppressive agents
- Prior thoracic radiotherapy
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm C: CCRT + durvalumab durvalumab Concurrent chemoradiotherapy (CCRT) Arm A: nivolumab + CCRT + ipilimumab nivolumab Concurrent chemoradiotherapy (CCRT) Arm A: nivolumab + CCRT + ipilimumab ipilimumab Concurrent chemoradiotherapy (CCRT) Arm B: nivolumab + CCRT nivolumab Concurrent chemoradiotherapy (CCRT)
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A vs Arm C Up to 7 years
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to 7 years Time to Death or Distant Metastases (TTDM) by RECIST 1.1 per Investigator assessment Up to 7 years Overall Survival (OS) for Arm A vs Arm C Up to 7 years OS for Arm B vs Arm C Up to 7 years OS for Arm A vs Arm B Up to 7 years PFS by RECIST 1.1 per BICR for Arm B vs Arm C Up to 7 years Time to Response (TTR) by RECIST 1.1 per BICR Up to 7 years PFS by RECIST 1.1 per BICR for Arm A vs Arm B Up to 7 years Objective Response Rate (ORR) by RECIST 1.1 per BICR Up to 7 years Duration of Response (DoR) by RECIST 1.1 per BICR Up to 7 years PFS by RECIST 1.1 per Investigator assessment Up to 7 years ORR by RECIST 1.1 per Investigator assessment Up to 7 years Incidence of select AEs Up to 7 years Incidence of Serious Adverse Events (SAEs) Up to 7 years DoR by RECIST 1.1 per Investigator assessment Up to 7 years TTR by RECIST 1.1 per Investigator assessment Up to 7 years Proportion of participants without symptom deterioration based on NSCLC-SAQ Up to 7 years Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ)
Trial Locations
- Locations (179)
Local Institution - 0071
🇺🇸Burlington, Vermont, United States
Local Institution - 0124
🇺🇸Cleveland, Ohio, United States
Local Institution - 0053
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0119
🇺🇸La Jolla, California, United States
Local Institution - 0129
🇺🇸Lone Tree, Colorado, United States
Local Institution - 0233
🇺🇸Jacksonville, Florida, United States
Local Institution - 0125
🇺🇸Atlanta, Georgia, United States
Local Institution - 0039
🇺🇸Pensacola, Florida, United States
Local Institution - 0165
🇺🇸Augusta, Georgia, United States
Local Institution - 0116
🇺🇸Traverse City, Michigan, United States
Local Institution - 0218
🇺🇸Edgewood, Kentucky, United States
Local Institution - 0131
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0112
🇺🇸Cleveland, Ohio, United States
Local Institution - 0047
🇺🇸Cleveland, Ohio, United States
Local Institution - 0188
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0123
🇺🇸Youngstown, Ohio, United States
Local Institution - 0191
🇺🇸Austin, Texas, United States
Local Institution - 0079
🇺🇸Bryan, Texas, United States
Local Institution - 0130
🇺🇸Dallas, Texas, United States
Local Institution - 0044
🇦🇷Caba, Buenos Aires, Argentina
Local Institution - 0045
🇦🇷Río Cuarto, Cordoba, Argentina
Local Institution - 0043
🇦🇷Buenos Aires, Distrito Federal, Argentina
Local Institution - 0042
🇦🇷Caba, Distrito Federal, Argentina
Local Institution - 0031
🇦🇺Darlinghurst, New South Wales, Australia
Local Institution - 0134
🇦🇺Gosford, New South Wales, Australia
Local Institution - 0033
🇦🇺Kingswood, New South Wales, Australia
Local Institution - 0029
🇦🇺Greenslopes, Queensland, Australia
Local Institution - 0224
🇦🇺Ballarat Central, Victoria, Australia
Local Institution - 0028
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0052
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0003
🇧🇪Bruxelles, Belgium
Local Institution
🇷🇺St. Petersburg, Russian Federation
Local Institution - 0030
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 0001
🇧🇪Gent, Belgium
Local Institution - 0002
🇧🇪Yvoir, Belgium
Local Institution - 0234
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0004
🇧🇪Liege, Belgium
Local Institution - 0127
🇨🇦Kingston, Ontario, Canada
Local Institution - 0036
🇧🇷Barretos, SAO Paulo, Brazil
Local Institution - 0035
🇧🇷Rio de Janeiro, Brazil
Local Institution - 0078
🇨🇦Oshawa, Ontario, Canada
Local Institution - 0126
🇨🇦Quebec, Canada
Local Institution - 0092
🇨🇦Trois-Rivieres, Quebec, Canada
Local Institution - 0087
🇫🇷Dijon, France
Local Institution - 0086
🇫🇷Bordeaux, France
Local Institution - 0082
🇫🇷Montpellier, France
Local Institution - 0084
🇫🇷Nantes, France
Local Institution - 0090
🇫🇷Paris Cedex 14, France
Local Institution - 0083
🇫🇷Paris Cedex 5, France
Local Institution - 0227
🇫🇷Paris, France
Local Institution - 0089
🇫🇷Tours Cedex 09, France
Local Institution - 0060
🇩🇪Berlin, Germany
Local Institution - 0091
🇫🇷Paris, France
Local Institution - 0063
🇩🇪Essen, Germany
Local Institution - 0076
🇩🇪Grosshansdorf, Germany
Local Institution - 0061
🇩🇪Immenhausen, Germany
Local Institution - 0073
🇩🇪Heidelberg, Germany
Local Institution - 0101
🇩🇪Hamm, Germany
Local Institution - 0062
🇩🇪Kempten, Germany
Local Institution - 0075
🇩🇪Loewenstein, Germany
Local Institution - 0109
🇩🇪Mainz, Germany
Local Institution - 0072
🇩🇪Stuttgart, Germany
Local Institution - 0161
🇬🇷Athens, Greece
Local Institution - 0135
🇬🇷Athens, Greece
Local Institution - 0023
🇮🇪Dublin, Ireland
Local Institution - 0068
🇮🇹Brescia, Italy
Local Institution - 0136
🇬🇷Larissa, Greece
Local Institution - 0162
🇬🇷N.Kifissia, Greece
Azienda Ospedaliero-Universitaria Mater Domini
🇮🇹Catanzaro, Italy
Aou Policlinico V. Emanuele Di Catania
🇮🇹Catania, Italy
Local Institution - 0050
🇮🇹Lucca, Italy
Local Institution - 0115
🇮🇹Milano, Italy
Local Institution - 0114
🇮🇹Monza (MB), Italy
Local Institution - 0048
🇮🇹Perugia, Italy
Local Institution - 0204
🇯🇵Nagoya, Aichi, Japan
Local Institution - 0212
🇯🇵Fukuoka-shi, Fukuoka, Japan
Local Institution - 0211
🇯🇵Kurume-shi, Fukuoka, Japan
Local Institution - 0197
🇯🇵Ota, Gunma, Japan
Local Institution - 0195
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution - 0206
🇯🇵Kobe, Hyogo, Japan
Local Institution - 0203
🇯🇵Kanazawa-shi, Ishikawa, Japan
Local Institution - 0216
🇯🇵Yokohama-shi, Kanagawa, Japan
Local Institution - 0201
🇯🇵Yokohama-Shi, Kanagawa, Japan
Local Institution - 0217
🇯🇵Yokohama, Kanagawa, Japan
Local Institution - 0196
🇯🇵Sendai-shi, Miyagi, Japan
Local Institution - 0202
🇯🇵Niigata-shi, Niigata, Japan
Local Institution - 0210
🇯🇵Osakasayama, Osaka, Japan
Local Institution - 0205
🇯🇵Osaka-shi, Osaka, Japan
Local Institution - 0174
🇯🇵Kitaadachi-gun, Saitama, Japan
Local Institution - 0198
🇯🇵Hidaka-shi, Saitama, Japan
Local Institution - 0200
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0232
🇯🇵Ube, Yamaguchi, Japan
Local Institution - 0175
🇯🇵Wakayama, Japan
Local Institution - 0167
🇰🇷Cheongju-si, Chungcheonbuk-do,, Korea, Republic of
Local Institution - 0152
🇰🇷Seoul, Korea, Republic of
Local Institution - 0168
🇰🇷Seoul, Korea, Republic of
Local Institution - 0027
🇲🇽La Paz, BAJA Californa SUR, Mexico
Local Institution - 0005
🇳🇱Maastrict, Netherlands
Local Institution - 0006
🇳🇱Amsterdam, Netherlands
Local Institution - 0025
🇳🇱Arnhem, Netherlands
Local Institution - 0240
🇳🇱Leiden, Netherlands
Local Institution - 0026
🇳🇱Veldhoven, Netherlands
Local Institution - 0107
🇵🇱Bydgoszcz, Poland
Local Institution - 0102
🇵🇱Gdansk, Poland
Local Institution - 0104
🇵🇱Krakow, Poland
Local Institution - 0235
🇵🇱Tomaszow Mazowiecki, Poland
Local Institution - 0120
🇵🇷Hato Rey, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico
Local Institution - 0222
🇷🇴Bucuresti, Romania
Local Institution - 0018
🇷🇴Bucharest, Romania
Local Institution - 0019
🇷🇴Cluj-Napoca, Romania
Local Institution - 0020
🇷🇴Constanta, Romania
Local Institution - 0017
🇷🇴Craiova, Romania
Local Institution - 0021
🇷🇴Floresti/ Cluj, Romania
Local Institution - 0171
🇸🇬Singapore, Singapore
Local Institution - 0106
🇪🇸Barcelona, Spain
Local Institution - 0095
🇪🇸Madrid, Spain
Local Institution - 0099
🇪🇸Hospitalet de Llobregat, Spain
Local Institution - 0096
🇪🇸Madrid, Spain
Local Institution - 0098
🇪🇸Pamplona, Spain
Local Institution - 0097
🇪🇸Sevilla, Spain
Local Institution - 0105
🇪🇸Santiago de Compostela, Spain
Local Institution - 0064
🇸🇪Stockholm, Sweden
Local Institution - 0065
🇸🇪Goteborg, Vastra Gotalands Lan, Sweden
Local Institution - 0057
🇨🇭Basel, Switzerland
Local Institution - 0058
🇨🇭Lausanne, Switzerland
Local Institution - 0059
🇨🇭St.Gallen, Switzerland
Local Institution - 0214
🇨🇳New Taipei City, Taiwan
Local Institution - 0209
🇨🇳Tainan, Taiwan
Local Institution - 0133
🇨🇳Taipei City, Taiwan
Local Institution - 0213
🇨🇳Taipei, Taiwan
Local Institution - 0010
🇬🇧Poole, Dorset, United Kingdom
Local Institution - 0012
🇬🇧Swansea, Glamorgan, United Kingdom
Local Institution - 0143
🇨🇳Taipei, Taiwan
Local Institution - 0007
🇬🇧Bebington, United Kingdom
Local Institution - 0054
🇬🇧Aberdeen, United Kingdom
Local Institution - 0009
🇬🇧Hull, United Kingdom
Local Institution - 0038
🇧🇷Ipatinga, Minas Gerais, Brazil
Local Institution - 0024
🇮🇪Dublin 8, Dublin, Ireland
Local Institution - 0015
🇲🇽Culiacan, Sinaloa, Mexico
Local Institution - 0034
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0037
🇧🇷Blumenau, Santa Catarina, Brazil
Local Institution - 0040
🇨🇱Vina del Mar, Valparaiso, Chile
Local Institution - 0067
🇲🇽Df, Distrito Federal, Mexico
Local Institution - 0041
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0199
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0014
🇲🇽Monterrey, Nuevo LEON, Mexico
Local Institution - 0056
🇨🇭Zuerich, Switzerland
Local Institution - 0080
🇲🇽Guadalajara, Jalisco, Mexico
Local Institution - 0208
🇨🇳KaohsiungCity, Taiwan
Local Institution - 0148
🇨🇳Wuhan, Hubei, China
Local Institution - 0192
🇨🇳Guiyang, Guizhou, China
Local Institution - 0147
🇨🇳Hankou, Hubei, China
Local Institution - 0150
🇨🇳Wuhan, Hubei, China
Local Institution - 0146
🇨🇳Beijing, BEI, China
Local Institution - 0149
🇨🇳Chongqing, Chongqing, China
Local Institution - 0179
🇨🇳Fuzhou, Fujian, China
Local Institution - 0164
🇨🇳Xiamen, Fujian, China
Local Institution - 0154
🇨🇳Changsha, Hunan, China
Local Institution - 0139
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0178
🇨🇳Nanchang, Jiangxi, China
Local Institution - 0170
🇨🇳Changchun, Jilin, China
Local Institution - 0183
🇨🇳Changchun, Jilin, China
Local Institution - 0180
🇨🇳Gongzhuling, Jilin, China
Local Institution - 0138
🇨🇳Jinan, Shandong, China
Local Institution - 0186
🇨🇳Chengdu, Sichuan, China
Local Institution - 0145
🇨🇳Shanghai, Shanghai, China
Local Institution - 0189
🇨🇳Chengdu, Sichuan, China
Local Institution - 0140
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0184
🇨🇳Linhai, Zhejiang, China
Local Institution - 0207
🇺🇸San Francisco, California, United States
Local Institution - 0166
🇺🇸San Francisco, California, United States
Local Institution - 0070
🇨🇦Rimouski, Quebec, Canada
Local Institution - 0237
🇨🇦Chicoutimi, Quebec, Canada
Local Institution - 0081
🇫🇷Lyon, France
Local Institution - 0100
🇪🇸Zaragoza, Spain
Local Institution - 0219
🇺🇸Orlando, Florida, United States
Local Institution - 0077
🇺🇸Charleston, South Carolina, United States
Local Institution - 0108
🇺🇸Bethesda, Maryland, United States