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

NCT ID: NCT04026412

Last Updated: 2025-07-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

925 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-08

Study Completion Date

2024-11-26

Brief Summary

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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

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Conditions

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Non-Small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: nivolumab + CCRT + ipilimumab

Concurrent chemoradiotherapy (CCRT)

Group Type EXPERIMENTAL

nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Arm B: nivolumab + CCRT

Concurrent chemoradiotherapy (CCRT)

Group Type EXPERIMENTAL

nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Arm C: CCRT + durvalumab

Concurrent chemoradiotherapy (CCRT)

Group Type EXPERIMENTAL

durvalumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

ipilimumab

Specified dose on specified days

Intervention Type BIOLOGICAL

durvalumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0119

La Jolla, California, United States

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Local Institution - 0207

San Francisco, California, United States

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Local Institution - 0166

San Francisco, California, United States

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Local Institution - 0129

Lone Tree, Colorado, United States

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Local Institution - 0233

Jacksonville, Florida, United States

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Local Institution - 0219

Orlando, Florida, United States

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Local Institution - 0039

Pensacola, Florida, United States

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Local Institution - 0125

Atlanta, Georgia, United States

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Local Institution - 0165

Augusta, Georgia, United States

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Local Institution - 0218

Edgewood, Kentucky, United States

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Local Institution - 0108

Bethesda, Maryland, United States

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Local Institution - 0116

Traverse City, Michigan, United States

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Local Institution - 0053

Cincinnati, Ohio, United States

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Local Institution - 0131

Cincinnati, Ohio, United States

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Local Institution - 0188

Cincinnati, Ohio, United States

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Local Institution - 0112

Cleveland, Ohio, United States

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Local Institution - 0124

Cleveland, Ohio, United States

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Local Institution - 0047

Cleveland, Ohio, United States

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Local Institution - 0123

Youngstown, Ohio, United States

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Local Institution - 0077

Charleston, South Carolina, United States

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Local Institution - 0191

Austin, Texas, United States

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Local Institution - 0079

Bryan, Texas, United States

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Local Institution - 0130

Dallas, Texas, United States

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Local Institution - 0071

Burlington, Vermont, United States

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Local Institution - 0044

CABA, Buenos Aires, Argentina

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Local Institution - 0045

Río Cuarto, Córdoba Province, Argentina

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Local Institution - 0043

Buenos Aires, Distrito Federal, Argentina

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Local Institution - 0042

Caba, Distrito Federal, Argentina

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Local Institution - 0031

Darlinghurst, New South Wales, Australia

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Local Institution - 0134

Gosford, New South Wales, Australia

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Local Institution - 0033

Kingswood, New South Wales, Australia

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Local Institution - 0029

Greenslopes, Queensland, Australia

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Local Institution - 0028

Adelaide, South Australia, Australia

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Local Institution - 0224

Ballarat Central, Victoria, Australia

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Local Institution - 0052

Melbourne, Victoria, Australia

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Melbourne, Victoria, Australia

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Local Institution - 0030

Murdoch, Western Australia, Australia

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Local Institution - 0003

Brussels, , Belgium

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Local Institution - 0001

Ghent, , Belgium

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Local Institution - 0004

Liège, , Belgium

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Local Institution - 0002

Yvoir, , Belgium

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Local Institution - 0038

Ipatinga, Minas Gerais, Brazil

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Local Institution - 0234

Ijuí, Rio Grande do Sul, Brazil

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Local Institution - 0034

Porto Alegre, Rio Grande do Sul, Brazil

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Local Institution - 0037

Blumenau, Santa Catarina, Brazil

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Local Institution - 0036

Barretos, São Paulo, Brazil

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Local Institution - 0035

Rio de Janeiro, , Brazil

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Local Institution - 0127

Kingston, Ontario, Canada

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Local Institution - 0078

Oshawa, Ontario, Canada

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Local Institution - 0237

Chicoutimi, Quebec, Canada

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Local Institution - 0126

Québec, Quebec, Canada

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Local Institution - 0070

Rimouski, Quebec, Canada

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Local Institution - 0092

Trois-Rivières, Quebec, Canada

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Local Institution - 0040

Viña del Mar, Región de Valparaíso, Chile

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Local Institution - 0041

Santiago, Santiago Metropolitan, Chile

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Local Institution - 0146

Beijing, BEI, China

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Local Institution - 0149

Chongqing, Chongqing Municipality, China

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Local Institution - 0179

Fuzhou, Fujian, China

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Local Institution - 0164

Xiamen, Fujian, China

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Local Institution - 0192

Guiyang, Guizhou, China

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Local Institution - 0147

Hankou, Hubei, China

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Local Institution - 0148

Wuhan, Hubei, China

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Local Institution - 0150

Wuhan, Hubei, China

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Local Institution - 0154

Changsha, Hunan, China

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Local Institution - 0139

Nanjing, Jiangsu, China

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Local Institution - 0178

Nanchang, Jiangxi, China

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Local Institution - 0170

Changchun, Jilin, China

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Local Institution - 0183

Changchun, Jilin, China

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Local Institution - 0180

Gongzhuling, Jilin, China

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Local Institution - 0138

Jinan, Shandong, China

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Local Institution - 0145

Shanghai, Shanghai Municipality, China

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Local Institution - 0186

Chengdu, Sichuan, China

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Local Institution - 0189

Chengdu, Sichuan, China

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Local Institution - 0140

Hangzhou, Zhejiang, China

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Local Institution - 0184

Linhai, Zhejiang, China

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Local Institution - 0086

Bordeaux, , France

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Local Institution - 0087

Dijon, , France

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Local Institution - 0081

Lyon, , France

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Montpellier, , France

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Nantes, , France

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Local Institution - 0227

Paris, , France

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Local Institution - 0091

Paris, , France

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Paris, , France

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Paris, , France

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Tours, , France

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Berlin, , Germany

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Local Institution - 0063

Essen, , Germany

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Local Institution - 0076

Großhansdorf, , Germany

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Local Institution - 0101

Hamm, , Germany

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Local Institution - 0073

Heidelberg, , Germany

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Local Institution - 0061

Immenhausen, , Germany

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Local Institution - 0062

Kempten, , Germany

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Local Institution - 0075

Löwenstein, , Germany

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Local Institution - 0109

Mainz, , Germany

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Local Institution - 0072

Stuttgart, , Germany

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Local Institution - 0161

Athens, , Greece

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Local Institution - 0135

Athens, , Greece

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Local Institution - 0136

Larissa, , Greece

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Local Institution - 0162

N.Kifissia, , Greece

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Local Institution - 0024

Dublin, Dublin, Ireland

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Local Institution - 0023

Dublin, , Ireland

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Local Institution - 0114

Monza (MB), Monza (MB), Italy

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Local Institution - 0068

Brescia, , Italy

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Aou Policlinico V. Emanuele Di Catania

Catania, , Italy

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Azienda Ospedaliero-Universitaria Mater Domini

Catanzaro, , Italy

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Local Institution - 0050

Lucca, , Italy

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Local Institution - 0115

Milan, , Italy

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Local Institution - 0048

Perugia, , Italy

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Local Institution - 0204

Nagoya, Aichi-ken, Japan

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Local Institution - 0212

Fukuoka, Fukuoka, Japan

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Local Institution - 0211

Kurume-shi, Fukuoka, Japan

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Local Institution - 0197

Ōta, Gunma, Japan

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Local Institution - 0195

Sapporo, Hokkaido, Japan

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Local Institution - 0206

Kobe, Hyōgo, Japan

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Local Institution - 0203

Kanazawa, Ishikawa-ken, Japan

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Local Institution - 0216

Yokohama, Kanagawa, Japan

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Local Institution - 0201

Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Local Institution - 0196

Sendai, Miyagi, Japan

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Niigata, Niigata, Japan

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Osaka, Osaka, Japan

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Local Institution - 0210

Sayama, Osaka, Japan

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Local Institution - 0198

Hidaka-shi, Saitama, Japan

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Local Institution - 0174

Kitaadachi-gun, Saitama, Japan

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Bunkyo-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Local Institution - 0232

Ube, Yamaguchi, Japan

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Local Institution - 0175

Wakayama, , Japan

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Local Institution - 0027

La Paz, BAJA Californa SUR, Mexico

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Local Institution - 0080

Guadalajara, Jalisco, Mexico

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Local Institution - 0067

Df, Mexico City, Mexico

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Local Institution - 0014

Monterrey, Nuevo León, Mexico

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Culiacán, Sinaloa, Mexico

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Local Institution - 0006

Amsterdam, , Netherlands

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Arnhem, , Netherlands

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Local Institution - 0240

Leiden, , Netherlands

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Maastrict, , Netherlands

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Veldhoven, , Netherlands

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Local Institution - 0107

Bydgoszcz, , Poland

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Local Institution - 0102

Gdansk, , Poland

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Local Institution - 0104

Krakow, , Poland

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Local Institution - 0235

Tomaszów Mazowiecki, , Poland

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Local Institution - 0120

Hato Rey, , Puerto Rico

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GCM Medical Group, PSC - Hato Rey Site

San Juan, , Puerto Rico

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Local Institution - 0018

Bucharest, , Romania

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Local Institution - 0222

Bucharest, , Romania

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Local Institution - 0019

Cluj-Napoca, , Romania

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Local Institution - 0020

Constanța, , Romania

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Craiova, , Romania

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Local Institution - 0021

Floresti/ Cluj, , Romania

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Local Institution - 0171

Singapore, , Singapore

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Local Institution - 0167

Cheongju-si, Chungcheonbuk-do,, , South Korea

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Local Institution - 0152

Seoul, , South Korea

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Local Institution - 0168

Seoul, , South Korea

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Local Institution - 0106

Barcelona, , Spain

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Local Institution - 0099

L'Hospitalet de Llobregat, , Spain

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Local Institution - 0096

Madrid, , Spain

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Local Institution - 0095

Madrid, , Spain

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Local Institution - 0098

Pamplona, , Spain

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Local Institution - 0105

Santiago de Compostela, , Spain

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Local Institution - 0097

Seville, , Spain

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Local Institution - 0100

Zaragoza, , Spain

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Local Institution - 0065

Gothenburg, Västra Götaland County, Sweden

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Local Institution - 0064

Stockholm, , Sweden

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Local Institution - 0057

Basel, , Switzerland

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Local Institution - 0058

Lausanne, , Switzerland

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Local Institution - 0059

Sankt Gallen, , Switzerland

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Local Institution - 0056

Zurich, , Switzerland

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Local Institution - 0208

KaohsiungCity, , Taiwan

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Local Institution - 0214

New Taipei City, , Taiwan

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Local Institution - 0209

Tainan City, , Taiwan

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Local Institution - 0213

Taipei, , Taiwan

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Local Institution - 0133

Taipei, , Taiwan

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Local Institution - 0143

Taipei, , Taiwan

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Local Institution - 0010

Poole, Dorset, United Kingdom

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Local Institution - 0012

Swansea, Glamorgan, United Kingdom

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Local Institution - 0054

Aberdeen, , United Kingdom

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Local Institution - 0007

Bebington, , United Kingdom

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Local Institution - 0009

Hull, , United Kingdom

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Countries

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United States Argentina Australia Belgium Brazil Canada Chile China France Germany Greece Ireland Italy Japan Mexico Netherlands Poland Puerto Rico Romania Russia Singapore South Korea Spain Sweden Switzerland Taiwan United Kingdom

References

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De Ruysscher D, Ramalingam S, Urbanic J, Gerber DE, Tan DSW, Cai J, Li A, Peters S. CheckMate 73L: A Phase 3 Study Comparing Nivolumab Plus Concurrent Chemoradiotherapy Followed by Nivolumab With or Without Ipilimumab Versus Concurrent Chemoradiotherapy Followed by Durvalumab for Previously Untreated, Locally Advanced Stage III Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2022 May;23(3):e264-e268. doi: 10.1016/j.cllc.2021.07.005. Epub 2021 Jul 19.

Reference Type DERIVED
PMID: 34489161 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2019-001222-98

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-73L

Identifier Type: -

Identifier Source: org_study_id

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