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

NCT04026412 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-73L2019-001222-98
• Study Type: interventional
• Target: 925
• Locations: 27 countries
• Sites: 183

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).

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR)

  Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

  From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months)

Secondary Outcomes (12)

• Overall Survival (OS)

  From randomization untill death (up to approximately 61 months)

• Arm B Vs Arm C and Arm A Vs Arm B- Progression-Free Survival (Irrespective of Subsequent Therapy) by RECIST 1.1 Per Blinded Independent Central Review (BICR)

  From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

• Objective Response Rate (ORR) by BICR

  From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

• Duration of Response (DoR) by RECIST 1.1 Per BICR

  From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

• Time to Response (TTR) by RECIST 1.1 Per BICR

  From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

Study Arms (3)

Arm A: nivolumab + CCRT + ipilimumab

EXPERIMENTAL

Concurrent chemoradiotherapy (CCRT)

Biological: nivolumab; Biological: ipilimumab

Arm B: nivolumab + CCRT

EXPERIMENTAL

Concurrent chemoradiotherapy (CCRT)

Biological: nivolumab

Arm C: CCRT + durvalumab

EXPERIMENTAL

Concurrent chemoradiotherapy (CCRT)

Biological: durvalumab

Interventions

nivolumab BIOLOGICAL

Specified dose on specified days

Arm A: nivolumab + CCRT + ipilimumab; Arm B: nivolumab + CCRT

ipilimumab BIOLOGICAL

Specified dose on specified days

Arm A: nivolumab + CCRT + ipilimumab

durvalumab BIOLOGICAL

Specified dose on specified days

Arm C: CCRT + durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (183)

Local Institution - 0119

La Jolla, California, 92093, United States

Location

Local Institution - 0207

San Francisco, California, 94115, United States

Location

Local Institution - 0166

San Francisco, California, 94143, United States

Location

Local Institution - 0129

Lone Tree, Colorado, 80124, United States

Location

Local Institution - 0233

Jacksonville, Florida, 32207, United States

Location

Local Institution - 0219

Orlando, Florida, 32804, United States

Location

Local Institution - 0039

Pensacola, Florida, 32504, United States

Location

Local Institution - 0125

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0165

Augusta, Georgia, 30912, United States

Location

Local Institution - 0218

Edgewood, Kentucky, 41017, United States

Location

Local Institution - 0108

Bethesda, Maryland, 20817, United States

Location

Local Institution - 0116

Traverse City, Michigan, 49684, United States

Location

Local Institution - 0053

Cincinnati, Ohio, 45220, United States

Location

Local Institution - 0131

Cincinnati, Ohio, 45242, United States

Location

Local Institution - 0188

Cincinnati, Ohio, 45267, United States

Location

Local Institution - 0112

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0124

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0047

Cleveland, Ohio, 44109, United States

Location

Local Institution - 0123

Youngstown, Ohio, 44501, United States

Location

Local Institution - 0077

Charleston, South Carolina, 29414, United States

Location

Local Institution - 0191

Austin, Texas, 78731, United States

Location

Local Institution - 0079

Bryan, Texas, 77802, United States

Location

Local Institution - 0130

Dallas, Texas, 75203, United States

Location

Local Institution - 0071

Burlington, Vermont, 05405, United States

Location

Local Institution - 0044

CABA, Buenos Aires, C1426ANZ, Argentina

Location

Local Institution - 0045

Río Cuarto, Córdoba Province, 5800, Argentina

Location

Local Institution - 0043

Buenos Aires, Distrito Federal, C1199ABB, Argentina

Location

Local Institution - 0042

Caba, Distrito Federal, 1430, Argentina

Location

Local Institution - 0031

Darlinghurst, New South Wales, 2010, Australia

Location

Local Institution - 0134

Gosford, New South Wales, 2250, Australia

Location

Local Institution - 0033

Kingswood, New South Wales, 2747, Australia

Location

Local Institution - 0029

Greenslopes, Queensland, 4120, Australia

Location

Local Institution - 0028

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0224

Ballarat Central, Victoria, 3350, Australia

Location

Local Institution - 0052

Melbourne, Victoria, 3004, Australia

Location

Local Institution

Melbourne, Victoria, 3199, Australia

Location

Local Institution - 0030

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0003

Brussels, 1200, Belgium

Location

Local Institution - 0001

Ghent, 9000, Belgium

Location

Local Institution - 0004

Liège, 4000, Belgium

Location

Local Institution - 0002

Yvoir, B-5530, Belgium

Location

Local Institution - 0038

Ipatinga, Minas Gerais, 35160-158, Brazil

Location

Local Institution - 0234

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution - 0034

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Local Institution - 0037

Blumenau, Santa Catarina, 89010-340, Brazil

Location

Local Institution - 0036

Barretos, São Paulo, 14784-400, Brazil

Location

Local Institution - 0035

Rio de Janeiro, 20230-130, Brazil

Location

Local Institution - 0127

Kingston, Ontario, K7L 2V7, Canada

Location

Local Institution - 0078

Oshawa, Ontario, L1G 2B9, Canada

Location

Local Institution - 0237

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Local Institution - 0126

Québec, Quebec, G1V 4G5, Canada

Location

Local Institution - 0070

Rimouski, Quebec, G5L 5T1, Canada

Location

Local Institution - 0092

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Local Institution - 0040

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Local Institution - 0041

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0146

Beijing, BEI, 100142, China

Location

Local Institution - 0149

Chongqing, Chongqing Municipality, 400030, China

Location

Local Institution - 0179

Fuzhou, Fujian, 350000, China

Location

Local Institution - 0164

Xiamen, Fujian, 361003, China

Location

Local Institution - 0192

Guiyang, Guizhou, 550002, China

Location

Local Institution - 0147

Hankou, Hubei, 430023, China

Location

Local Institution - 0148

Wuhan, Hubei, 210000, China

Location

Local Institution - 0150

Wuhan, Hubei, 430060, China

Location

Local Institution - 0154

Changsha, Hunan, 410011, China

Location

Local Institution - 0139

Nanjing, Jiangsu, 210009, China

Location

Local Institution - 0178

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0170

Changchun, Jilin, 130012, China

Location

Local Institution - 0183

Changchun, Jilin, 130021, China

Location

Local Institution - 0180

Gongzhuling, Jilin, 132000, China

Location

Local Institution - 0138

Jinan, Shandong, 250117, China

Location

Local Institution - 0145

Shanghai, Shanghai Municipality, 200443, China

Location

Local Institution - 0186

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0189

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0140

Hangzhou, Zhejiang, 310000, China

Location

Local Institution - 0184

Linhai, Zhejiang, 317000, China

Location

Local Institution - 0086

Bordeaux, 33076, France

Location

Local Institution - 0087

Dijon, 21000, France

Location

Local Institution - 0081

Lyon, 69008, France

Location

Local Institution - 0082

Montpellier, 34070, France

Location

Local Institution - 0084

Nantes, 44000, France

Location

Local Institution - 0227

Paris, 75018, France

Location

Local Institution - 0091

Paris, 75020, France

Location

Local Institution - 0083

Paris, 75248, France

Location

Local Institution - 0090

Paris, 75679, France

Location

Local Institution - 0089

Tours, 37044, France

Location

Local Institution - 0060

Berlin, 14165, Germany

Location

Local Institution - 0063

Essen, 45136, Germany

Location

Local Institution - 0076

Großhansdorf, 22927, Germany

Location

Local Institution - 0101

Hamm, 59063, Germany

Location

Local Institution - 0073

Heidelberg, 69126, Germany

Location

Local Institution - 0061

Immenhausen, 34376, Germany

Location

Local Institution - 0062

Kempten, 87439, Germany

Location

Local Institution - 0075

Löwenstein, 74245, Germany

Location

Local Institution - 0109

Mainz, 55131, Germany

Location

Local Institution - 0072

Stuttgart, 70376, Germany

Location

Local Institution - 0161

Athens, 115 22, Greece

Location

Local Institution - 0135

Athens, 11527, Greece

Location

Local Institution - 0136

Larissa, 41110, Greece

Location

Local Institution - 0162

N.Kifissia, 14564, Greece

Location

Local Institution - 0024

Dublin, Dublin, Ireland

Location

Local Institution - 0023

Dublin, 00004, Ireland

Location

Local Institution - 0114

Monza (MB), Monza (MB), 20900, Italy

Location

Local Institution - 0068

Brescia, 25123, Italy

Location

Aou Policlinico V. Emanuele Di Catania

Catania, 95100, Italy

Location

Azienda Ospedaliero-Universitaria Mater Domini

Catanzaro, 88100, Italy

Location

Local Institution - 0050

Lucca, 55100, Italy

Location

Local Institution - 0115

Milan, 20141, Italy

Location

Local Institution - 0048

Perugia, 06129, Italy

Location

Local Institution - 0204

Nagoya, Aichi-ken, 4648681, Japan

Location

Local Institution - 0212

Fukuoka, Fukuoka, 8128582, Japan

Location

Local Institution - 0211

Kurume-shi, Fukuoka, 8300011, Japan

Location

Local Institution - 0197

Ōta, Gunma, 373-8550, Japan

Location

Local Institution - 0195

Sapporo, Hokkaido, 0030804, Japan

Location

Local Institution - 0206

Kobe, Hyōgo, 6500047, Japan

Location

Local Institution - 0203

Kanazawa, Ishikawa-ken, 9208641, Japan

Location

Local Institution - 0216

Yokohama, Kanagawa, 2210855, Japan

Location

Local Institution - 0201

Yokohama, Kanagawa, 2360051, Japan

Location

Local Institution - 0217

Yokohama, Kanagawa, 2418515, Japan

Location

Local Institution - 0196

Sendai, Miyagi, 9800873, Japan

Location

Local Institution - 0202

Niigata, Niigata, 9518566, Japan

Location

Local Institution - 0205

Osaka, Osaka, 5458586, Japan

Location

Local Institution - 0210

Sayama, Osaka, 589-8511, Japan

Location

Local Institution - 0198

Hidaka-shi, Saitama, 3501298, Japan

Location

Local Institution - 0174

Kitaadachi-gun, Saitama, 3620806, Japan

Location

Local Institution - 0199

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Local Institution - 0200

Chuo-ku, Tokyo, 1040045, Japan

Location

Local Institution - 0232

Ube, Yamaguchi, 755-0241, Japan

Location

Local Institution - 0175

Wakayama, 641-8509, Japan

Location

Local Institution - 0027

La Paz, BAJA Californa SUR, 23040, Mexico

Location

Local Institution - 0080

Guadalajara, Jalisco, 44340, Mexico

Location

Local Institution - 0067

Df, Mexico City, 06720, Mexico

Location

Local Institution - 0014

Monterrey, Nuevo León, 64060, Mexico

Location

Local Institution - 0015

Culiacán, Sinaloa, 80230, Mexico

Location

Local Institution - 0006

Amsterdam, 1081HV, Netherlands

Location

Local Institution - 0025

Arnhem, 6815 AD, Netherlands

Location

Local Institution - 0240

Leiden, 2333ZA, Netherlands

Location

Local Institution - 0005

Maastrict, 6229 HX, Netherlands

Location

Local Institution - 0026

Veldhoven, 5504 DB, Netherlands

Location

Local Institution - 0107

Bydgoszcz, 85796, Poland

Location

Local Institution - 0102

Gdansk, 80-214, Poland

Location

Local Institution - 0104

Krakow, 31-826, Poland

Location

Local Institution - 0235

Tomaszów Mazowiecki, 97-200, Poland

Location

Local Institution - 0120

Hato Rey, 00917, Puerto Rico

Location

GCM Medical Group, PSC - Hato Rey Site

San Juan, 917, Puerto Rico

Location

Local Institution - 0018

Bucharest, 022328, Romania

Location

Local Institution - 0222

Bucharest, 022548, Romania

Location

Local Institution - 0019

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0020

Constanța, 900591, Romania

Location

Local Institution - 0017

Craiova, 200542, Romania

Location

Local Institution - 0021

Floresti/ Cluj, 407280, Romania

Location

Local Institution

Moscow, 105229, Russia

Location

Local Institution

Moscow, 115478, Russia

Location

Local Institution

Moscow, 125367, Russia

Location

Local Institution

Saint Petersburg, 197758, Russia

Location

Local Institution - 0171

Singapore, 168583, Singapore

Location

Local Institution - 0167

Cheongju-si, Chungcheonbuk-do,, 361-711, South Korea

Location

Local Institution - 0152

Seoul, 03722, South Korea

Location

Local Institution - 0168

Seoul, 06351, South Korea

Location

Local Institution - 0106

Barcelona, 8025, Spain

Location

Local Institution - 0099

L'Hospitalet de Llobregat, 08907, Spain

Location

Local Institution - 0096

Madrid, 28007, Spain

Location

Local Institution - 0095

Madrid, 28046, Spain

Location

Local Institution - 0098

Pamplona, 31008, Spain

Location

Local Institution - 0105

Santiago de Compostela, 15706, Spain

Location

Local Institution - 0097

Seville, 41013, Spain

Location

Local Institution - 0100

Zaragoza, 50009, Spain

Location

Local Institution - 0065

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Local Institution - 0064

Stockholm, 171 76, Sweden

Location

Local Institution - 0057

Basel, 4031, Switzerland

Location

Local Institution - 0058

Lausanne, 1011, Switzerland

Location

Local Institution - 0059

Sankt Gallen, 9007, Switzerland

Location

Local Institution - 0056

Zurich, 8091, Switzerland

Location

Local Institution - 0208

KaohsiungCity, 83301, Taiwan

Location

Local Institution - 0214

New Taipei City, 235, Taiwan

Location

Local Institution - 0209

Tainan, 704, Taiwan

Location

Local Institution - 0213

Taipei, 10099, Taiwan

Location

Local Institution - 0133

Taipei, 100, Taiwan

Location

Local Institution - 0143

Taipei, 112, Taiwan

Location

Local Institution - 0010

Poole, Dorset, BH15 2JB, United Kingdom

Location

Local Institution - 0012

Swansea, Glamorgan, SA2 8QA, United Kingdom

Location

Local Institution - 0054

Aberdeen, AB25 2ZN, United Kingdom

Location

Local Institution - 0007

Bebington, CH63 4JY, United Kingdom

Location

Local Institution - 0009

Hull, HU16 5JQ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34489161 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Ipilimumab; durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 19, 2019
• Study Start: October 8, 2019
• Primary Completion: March 22, 2024
• Study Completion: November 26, 2024
• Last Updated: July 24, 2025
• Results First Posted: July 24, 2025

Record last verified: 2025-07

Locations

NL (5); CN (20); IT (7); IE (2); FR (10); PL (4); JP (20); RO (6); RU (4); SE (2); KR (3); BE (4); CA (6); BR (6); AR (4); DE (10); TW (6); SG (1); GR (4); ES (8); ME (5); US (24); AU (9); GB (5); CL (2); PR (2); CH (4)