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AzTrials

Non-Small Cell Lung Cancer (NSCLC)Phase 3CheckMate73LNCT04026412

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

A Phase 3 study testing nivolumab, ipilimumab and durvalumab in people with Non-Small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 183 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer (NSCLC)
What is being tested?
nivolumab, ipilimumab and durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
925 participants
Where
183 sitesin 27 countries
Study dates
8 Oct 2019to 26 Nov 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

183 sites in 27 countries.

183 sites in 27 countries

United States24 sites

  • Local Institution - 0125

    Atlanta, Georgia, 30322

  • Local Institution - 0165

    Augusta, Georgia, 30912

  • Local Institution - 0191

    Austin, Texas, 78731

  • Local Institution - 0108

    Bethesda, Maryland, 20817

  • Local Institution - 0079

    Bryan, Texas, 77802

  • Local Institution - 0071

    Burlington, Vermont, 05405

  • Local Institution - 0077

    Charleston, South Carolina, 29414

  • Local Institution - 0053

    Cincinnati, Ohio, 45220

  • Local Institution - 0131

    Cincinnati, Ohio, 45242

  • Local Institution - 0188

    Cincinnati, Ohio, 45267

  • Local Institution - 0112

    Cleveland, Ohio, 44106

  • Local Institution - 0124

    Cleveland, Ohio, 44106

  • Local Institution - 0047

    Cleveland, Ohio, 44109

  • Local Institution - 0130

    Dallas, Texas, 75203

  • Local Institution - 0218

    Edgewood, Kentucky, 41017

  • Local Institution - 0233

    Jacksonville, Florida, 32207

  • Local Institution - 0119

    La Jolla, California, 92093

  • Local Institution - 0129

    Lone Tree, Colorado, 80124

  • Local Institution - 0219

    Orlando, Florida, 32804

  • Local Institution - 0039

    Pensacola, Florida, 32504

  • Local Institution - 0207

    San Francisco, California, 94115

  • Local Institution - 0166

    San Francisco, California, 94143

  • Local Institution - 0116

    Traverse City, Michigan, 49684

  • Local Institution - 0123

    Youngstown, Ohio, 44501

Other trials in United States

China20 sites

  • Local Institution - 0146

    Beijing, BEI, 100142

  • Local Institution - 0170

    Changchun, Jilin, 130012

  • Local Institution - 0183

    Changchun, Jilin, 130021

  • Local Institution - 0154

    Changsha, Hunan, 410011

  • Local Institution - 0186

    Chengdu, Sichuan, 610041

  • Local Institution - 0189

    Chengdu, Sichuan, 610041

  • Local Institution - 0149

    Chongqing, Chongqing Municipality, 400030

  • Local Institution - 0179

    Fuzhou, Fujian, 350000

  • Local Institution - 0180

    Gongzhuling, Jilin, 132000

  • Local Institution - 0192

    Guiyang, Guizhou, 550002

  • Local Institution - 0140

    Hangzhou, Zhejiang, 310000

  • Local Institution - 0147

    Hankou, Hubei, 430023

  • Local Institution - 0138

    Jinan, Shandong, 250117

  • Local Institution - 0184

    Linhai, Zhejiang, 317000

  • Local Institution - 0178

    Nanchang, Jiangxi, 330006

  • Local Institution - 0139

    Nanjing, Jiangsu, 210009

  • Local Institution - 0145

    Shanghai, Shanghai Municipality, 200443

  • Local Institution - 0148

    Wuhan, Hubei, 210000

  • Local Institution - 0150

    Wuhan, Hubei, 430060

  • Local Institution - 0164

    Xiamen, Fujian, 361003

Other trials in China

Japan20 sites

  • Local Institution - 0199

    Bunkyo-ku, Tokyo, 113-8603

  • Local Institution - 0200

    Chuo-ku, Tokyo, 1040045

  • Local Institution - 0212

    Fukuoka, Fukuoka, 8128582

  • Local Institution - 0198

    Hidaka-shi, Saitama, 3501298

  • Local Institution - 0203

    Kanazawa, Ishikawa-ken, 9208641

  • Local Institution - 0174

    Kitaadachi-gun, Saitama, 3620806

  • Local Institution - 0206

    Kobe, Hyōgo, 6500047

  • Local Institution - 0211

    Kurume-shi, Fukuoka, 8300011

  • Local Institution - 0204

    Nagoya, Aichi-ken, 4648681

  • Local Institution - 0202

    Niigata, Niigata, 9518566

  • Local Institution - 0205

    Osaka, Osaka, 5458586

  • Local Institution - 0197

    Ōta, Gunma, 373-8550

  • Local Institution - 0195

    Sapporo, Hokkaido, 0030804

  • Local Institution - 0210

    Sayama, Osaka, 589-8511

  • Local Institution - 0196

    Sendai, Miyagi, 9800873

  • Local Institution - 0232

    Ube, Yamaguchi, 755-0241

  • Local Institution - 0175

    Wakayama, 641-8509

  • Local Institution - 0216

    Yokohama, Kanagawa, 2210855

  • Local Institution - 0201

    Yokohama, Kanagawa, 2360051

  • Local Institution - 0217

    Yokohama, Kanagawa, 2418515

Other trials in Japan

France10 sites

  • Local Institution - 0086

    Bordeaux, 33076

  • Local Institution - 0087

    Dijon, 21000

  • Local Institution - 0081

    Lyon, 69008

  • Local Institution - 0082

    Montpellier, 34070

  • Local Institution - 0084

    Nantes, 44000

  • Local Institution - 0227

    Paris, 75018

  • Local Institution - 0091

    Paris, 75020

  • Local Institution - 0083

    Paris, 75248

  • Local Institution - 0090

    Paris, 75679

  • Local Institution - 0089

    Tours, 37044

Other trials in France

Germany10 sites

  • Local Institution - 0060

    Berlin, 14165

  • Local Institution - 0063

    Essen, 45136

  • Local Institution - 0076

    Großhansdorf, 22927

  • Local Institution - 0101

    Hamm, 59063

  • Local Institution - 0073

    Heidelberg, 69126

  • Local Institution - 0061

    Immenhausen, 34376

  • Local Institution - 0062

    Kempten, 87439

  • Local Institution - 0075

    Löwenstein, 74245

  • Local Institution - 0109

    Mainz, 55131

  • Local Institution - 0072

    Stuttgart, 70376

Other trials in Germany

Australia9 sites

  • Local Institution - 0028

    Adelaide, South Australia, 5000

  • Local Institution - 0224

    Ballarat Central, Victoria, 3350

  • Local Institution - 0031

    Darlinghurst, New South Wales, 2010

  • Local Institution - 0134

    Gosford, New South Wales, 2250

  • Local Institution - 0029

    Greenslopes, Queensland, 4120

  • Local Institution - 0033

    Kingswood, New South Wales, 2747

  • Local Institution - 0052

    Melbourne, Victoria, 3004

  • Local Institution

    Melbourne, Victoria, 3199

  • Local Institution - 0030

    Murdoch, Western Australia, 6150

Other trials in Australia

Spain8 sites

  • Local Institution - 0106

    Barcelona, 8025

  • Local Institution - 0099

    L'Hospitalet de Llobregat, 08907

  • Local Institution - 0096

    Madrid, 28007

  • Local Institution - 0095

    Madrid, 28046

  • Local Institution - 0098

    Pamplona, 31008

  • Local Institution - 0105

    Santiago de Compostela, 15706

  • Local Institution - 0097

    Seville, 41013

  • Local Institution - 0100

    Zaragoza, 50009

Other trials in Spain

Italy7 sites

  • Local Institution - 0068

    Brescia, 25123

  • Aou Policlinico V. Emanuele Di Catania

    Catania, 95100

  • Azienda Ospedaliero-Universitaria Mater Domini

    Catanzaro, 88100

  • Local Institution - 0050

    Lucca, 55100

  • Local Institution - 0115

    Milan, 20141

  • Local Institution - 0114

    Monza (MB), Monza (MB), 20900

  • Local Institution - 0048

    Perugia, 06129

Other trials in Italy

Brazil6 sites

  • Local Institution - 0036

    Barretos, São Paulo, 14784-400

  • Local Institution - 0037

    Blumenau, Santa Catarina, 89010-340

  • Local Institution - 0234

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0038

    Ipatinga, Minas Gerais, 35160-158

  • Local Institution - 0034

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Local Institution - 0035

    Rio de Janeiro, 20230-130

Other trials in Brazil

Canada6 sites

  • Local Institution - 0237

    Chicoutimi, Quebec, G7H 5H6

  • Local Institution - 0127

    Kingston, Ontario, K7L 2V7

  • Local Institution - 0078

    Oshawa, Ontario, L1G 2B9

  • Local Institution - 0126

    Québec, Quebec, G1V 4G5

  • Local Institution - 0070

    Rimouski, Quebec, G5L 5T1

  • Local Institution - 0092

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Romania6 sites

  • Local Institution - 0018

    Bucharest, 022328

  • Local Institution - 0222

    Bucharest, 022548

  • Local Institution - 0019

    Cluj-Napoca, 400015

  • Local Institution - 0020

    Constanța, 900591

  • Local Institution - 0017

    Craiova, 200542

  • Local Institution - 0021

    Floresti/ Cluj, 407280

Other trials in Romania

Taiwan6 sites

  • Local Institution - 0208

    KaohsiungCity, 83301

  • Local Institution - 0214

    New Taipei City, 235

  • Local Institution - 0209

    Tainan, 704

  • Local Institution - 0213

    Taipei, 10099

  • Local Institution - 0133

    Taipei, 100

  • Local Institution - 0143

    Taipei, 112

Other trials in Taiwan

Mexico5 sites

  • Local Institution - 0015

    Culiacán, Sinaloa, 80230

  • Local Institution - 0067

    Df, Mexico City, 06720

  • Local Institution - 0080

    Guadalajara, Jalisco, 44340

  • Local Institution - 0027

    La Paz, BAJA Californa SUR, 23040

  • Local Institution - 0014

    Monterrey, Nuevo León, 64060

Other trials in Mexico

Netherlands5 sites

  • Local Institution - 0006

    Amsterdam, 1081HV

  • Local Institution - 0025

    Arnhem, 6815 AD

  • Local Institution - 0240

    Leiden, 2333ZA

  • Local Institution - 0005

    Maastrict, 6229 HX

  • Local Institution - 0026

    Veldhoven, 5504 DB

Other trials in Netherlands

United Kingdom5 sites

  • Local Institution - 0054

    Aberdeen, AB25 2ZN

  • Local Institution - 0007

    Bebington, CH63 4JY

  • Local Institution - 0009

    Hull, HU16 5JQ

  • Local Institution - 0010

    Poole, Dorset, BH15 2JB

  • Local Institution - 0012

    Swansea, Glamorgan, SA2 8QA

Other trials in United Kingdom

Argentina4 sites

  • Local Institution - 0043

    Buenos Aires, Distrito Federal, C1199ABB

  • Local Institution - 0042

    Caba, Distrito Federal, 1430

  • Local Institution - 0044

    CABA, Buenos Aires, C1426ANZ

  • Local Institution - 0045

    Río Cuarto, Córdoba Province, 5800

Other trials in Argentina

Belgium4 sites

  • Local Institution - 0003

    Brussels, 1200

  • Local Institution - 0001

    Ghent, 9000

  • Local Institution - 0004

    Liège, 4000

  • Local Institution - 0002

    Yvoir, B-5530

Other trials in Belgium

Greece4 sites

  • Local Institution - 0161

    Athens, 115 22

  • Local Institution - 0135

    Athens, 11527

  • Local Institution - 0136

    Larissa, 41110

  • Local Institution - 0162

    N.Kifissia, 14564

Other trials in Greece

Poland4 sites

  • Local Institution - 0107

    Bydgoszcz, 85796

  • Local Institution - 0102

    Gdansk, 80-214

  • Local Institution - 0104

    Krakow, 31-826

  • Local Institution - 0235

    Tomaszów Mazowiecki, 97-200

Other trials in Poland

Russia4 sites

  • Local Institution

    Moscow, 105229

  • Local Institution

    Moscow, 115478

  • Local Institution

    Moscow, 125367

  • Local Institution

    Saint Petersburg, 197758

Other trials in Russia

Switzerland4 sites

  • Local Institution - 0057

    Basel, 4031

  • Local Institution - 0058

    Lausanne, 1011

  • Local Institution - 0059

    Sankt Gallen, 9007

  • Local Institution - 0056

    Zurich, 8091

Other trials in Switzerland

South Korea3 sites

  • Local Institution - 0167

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

  • Local Institution - 0152

    Seoul, 03722

  • Local Institution - 0168

    Seoul, 06351

Other trials in South Korea

Chile2 sites

  • Local Institution - 0041

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0040

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Ireland2 sites

  • Local Institution - 0024

    Dublin, Dublin

  • Local Institution - 0023

    Dublin, 00004

Other trials in Ireland

Puerto Rico2 sites

  • Local Institution - 0120

    Hato Rey, 00917

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 917

Other trials in Puerto Rico

Sweden2 sites

  • Local Institution - 0065

    Gothenburg, Västra Götaland County, 41345

  • Local Institution - 0064

    Stockholm, 171 76

Other trials in Sweden

Singapore1 site

  • Local Institution - 0171

    Singapore, 168583

Other trials in Singapore

About this study

Official title: A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

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).

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nivolumabBiological

    Specified dose on specified days

  • ipilimumabBiological

    Specified dose on specified days

  • durvalumabBiological

    Specified dose on specified days

Study groups in NCT04026412
Study groupRoleWhat they receive
Arm A: nivolumab + CCRT + ipilimumabExperimentalConcurrent chemoradiotherapy (CCRT)
Receives: Biological: nivolumab; Biological: ipilimumab
Arm B: nivolumab + CCRTExperimentalConcurrent chemoradiotherapy (CCRT)
Receives: Biological: nivolumab
Arm C: CCRT + durvalumabExperimentalConcurrent chemoradiotherapy (CCRT)
Receives: Biological: durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (12)

  1. Overall Survival (OS)

    Overall Survival (OS) for all randomized participants is the time between randomization and the date of death from any cause based on Kaplan-Meier estimates. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.

    Measured: From randomization untill death (up to approximately 61 months)

  2. 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)

    Progression-Free Survival (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.

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

  3. Objective Response Rate (ORR) by BICR

    Objective Response Rate (ORR) is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    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.

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

  4. Duration of Response (DoR) by RECIST 1.1 Per BICR

    Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per BICR assessment, or death due to any cause, whichever occurs first.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    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.

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

  5. Time to Response (TTR) by RECIST 1.1 Per BICR

    Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per BICR.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    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.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

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

  6. Progression Free Survival (PFS) by RECIST 1.1 Per Investigator Assessment

    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 Investigator assessments (per RECIST v1.1), or death due to any cause, whichever occurs first Calculated using 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.

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

  7. Objective Response Rate (ORR) by RECIST 1.1 Per Investigator Assessment

    ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by investigator assessment per response evaluation criteria in solid tumors (RECIST) v1.1.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    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.

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

  8. Duration of Response (DOR) by RECIST 1.1 Per Investigator Assessment

    Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per investigator assessment, or death due to any cause, whichever occurs first.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    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.

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

  9. Time to Response (TTR) by RECIST 1.1 Per Investigator Assessment

    Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per investigator assessment.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    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.

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

  10. Time to Death or Distant Metastases (TDDM)

    Time to Death or Distant Metastases (TDDM) is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis based on Kaplan-Meier estimates. Distant metastasis is defined as any new lesion that is outside of the thorax (except for heart) according to RECIST 1.1, as assessed by the Investigator.

    Measured: From randomization until metastases or death, whichever occurs first (up to approximately 61 months)

  11. Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs

    An Adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.

    Measured: From first dose (Day 1) till 30 days after the last dose (up to approximately 19 months)

  12. Change From Baseline in Non-small Cell Lung Cancer (NSCLC)-Symptom Assessment Questionnaire (SAQ) Total Score at Week 48

    The NSCLC-SAQ is a questionnaire used in clinical trials to understand how non-small cell lung cancer (NSCLC) affects your daily life and well-being. It has 7 questions that ask about your symptoms over the past 7 days, including cough, pain, shortness of breath, fatigue, and appetite loss. The total scores from the questionnaire range from 0 to 20. A higher score means you have more severe symptoms and are feeling worse, which is a bad outcome. A lower score means you have fewer symptoms and are feeling better, which is a good outcome.

    Measured: Baseline (Day 1) and Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start8 Oct 2019
  3. Primary completion22 Mar 2024
  4. Study completion26 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
925 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04026412
Sponsor's protocol ID
CA209-73L
Other IDs
2019-001222-98, 2019
Acronym
CheckMate73L
Status last verified
Jul 2025
First submitted
18 Jul 2019
Last updated
24 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Peters S, Tan DSW, Gerber DE, Urbanic J, Ramalingam S, Yu J, Xing L, Rittmeyer A, Ciuleanu TE, de Menezes J, Kim HR, Rojas C, Syrigos K, Hayashi H, Haridass A, Cortinovis D, Bruno D, Kimmich M, Calles A, Nathani R, Pudussery G, Yang L, De Ruysscher D. Nivolumab plus chemoradiotherapy followed by nivolumab with or without ipilimumab for untreated locally advanced stage III NSCLC: a randomized phase 3 trial. Nat Cancer. 2026 Jul;7(7):1121-1132. doi: 10.1038/s43018-026-01161-y. Epub 2026 May 13.

    PubMed 42129521

  • 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.

    PubMed 34489161

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nivolumab, ipilimumab and durvalumab in people with Non-Small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 183 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in United States, China, Japan, France, Germany and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR) (time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04026412, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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