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 (CheckMate73L)

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).

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Biological: nivolumab; Biological: ipilimumab; Biological: durvalumab

• Study Type: Interventional
• Enrollment (Actual): 925
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1426ANZ
      • Local Institution - 0044
  • Cordoba
    • Río Cuarto, Cordoba, Argentina, 5800
      • Local Institution - 0045
  • Distrito Federal
    • Buenos Aires, Distrito Federal, Argentina, C1199ABB
      • Local Institution - 0043
    • Caba, Distrito Federal, Argentina, 1430
      • Local Institution - 0042
• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Local Institution - 0031
    • Gosford, New South Wales, Australia, 2250
      • Local Institution - 0134
    • Kingswood, New South Wales, Australia, 2747
      • Local Institution - 0033
  • Queensland
    • Greenslopes, Queensland, Australia, 4120
      • Local Institution - 0029
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution - 0028
  • Victoria
    • Ballarat Central, Victoria, Australia, 3350
      • Local Institution - 0224
    • Melbourne, Victoria, Australia, 3004
      • Local Institution - 0052
    • Melbourne, Victoria, Australia, 3199
      • Local Institution
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Local Institution - 0030
• Belgium
  • Bruxelles, Belgium, 1200
    • Local Institution - 0003
  • Gent, Belgium, 9000
    • Local Institution - 0001
  • Liege, Belgium, 4000
    • Local Institution - 0004
  • Yvoir, Belgium, B-5530
    • Local Institution - 0002
• Brazil
  • Rio de Janeiro, Brazil, 20230-130
    • Local Institution - 0035
  • Minas Gerais
    • Ipatinga, Minas Gerais, Brazil, 35160-158
      • Local Institution - 0038
  • RIO Grande DO SUL
    • Ijui, RIO Grande DO SUL, Brazil, 98700-000
      • Local Institution - 0234
    • Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
      • Local Institution - 0034
  • SAO Paulo
    • Barretos, SAO Paulo, Brazil, 14784-400
      • Local Institution - 0036
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89010-340
      • Local Institution - 0037
• Canada
  • Quebec, Canada, G1V 4G5
    • Local Institution - 0126
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Local Institution - 0127
    • Oshawa, Ontario, Canada, L1G 2B9
      • Local Institution - 0078
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Local Institution - 0237
    • Rimouski, Quebec, Canada, G5L 5T1
      • Local Institution - 0070
    • Trois-Rivieres, Quebec, Canada, G8Z 3R9
      • Local Institution - 0092
• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 8420383
      • Local Institution - 0041
  • Valparaiso
    • Vina del Mar, Valparaiso, Chile, 2520598
      • Local Institution - 0040
• China
  • BEI
    • Beijing, BEI, China, 100142
      • Local Institution - 0146
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Local Institution - 0149
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Local Institution - 0179
    • Xiamen, Fujian, China, 361003
      • Local Institution - 0164
  • Guizhou
    • Guiyang, Guizhou, China, 550002
      • Local Institution - 0192
  • Hubei
    • Hankou, Hubei, China, 430023
      • Local Institution - 0147
    • Wuhan, Hubei, China, 210000
      • Local Institution - 0148
    • Wuhan, Hubei, China, 430060
      • Local Institution - 0150
  • Hunan
    • Changsha, Hunan, China, 410011
      • Local Institution - 0154
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Local Institution - 0139
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Local Institution - 0178
  • Jilin
    • Changchun, Jilin, China, 130012
      • Local Institution - 0170
    • Changchun, Jilin, China, 130021
      • Local Institution - 0183
    • Gongzhuling, Jilin, China, 132000
      • Local Institution - 0180
  • Shandong
    • Jinan, Shandong, China, 250117
      • Local Institution - 0138
  • Shanghai
    • Shanghai, Shanghai, China, 200443
      • Local Institution - 0145
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Local Institution - 0186
    • Chengdu, Sichuan, China, 610041
      • Local Institution - 0189
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Local Institution - 0140
    • Linhai, Zhejiang, China, 317000
      • Local Institution - 0184
• France
  • Bordeaux, France, 33076
    • Local Institution - 0086
  • Dijon, France, 21000
    • Local Institution - 0087
  • Lyon, France, 69008
    • Local Institution - 0081
  • Montpellier, France, 34070
    • Local Institution - 0082
  • Nantes, France, 44000
    • Local Institution - 0084
  • Paris, France, 75018
    • Local Institution - 0227
  • Paris, France, 75020
    • Local Institution - 0091
  • Paris Cedex 14, France, 75679
    • Local Institution - 0090
  • Paris Cedex 5, France, 75248
    • Local Institution - 0083
  • Tours Cedex 09, France, 37044
    • Local Institution - 0089
• Germany
  • Berlin, Germany, 14165
    • Local Institution - 0060
  • Essen, Germany, 45136
    • Local Institution - 0063
  • Grosshansdorf, Germany, 22927
    • Local Institution - 0076
  • Hamm, Germany, 59063
    • Local Institution - 0101
  • Heidelberg, Germany, 69126
    • Local Institution - 0073
  • Immenhausen, Germany, 34376
    • Local Institution - 0061
  • Kempten, Germany, 87439
    • Local Institution - 0062
  • Loewenstein, Germany, 74245
    • Local Institution - 0075
  • Mainz, Germany, 55131
    • Local Institution - 0109
  • Stuttgart, Germany, 70376
    • Local Institution - 0072
• Greece
  • Athens, Greece, 115 22
    • Local Institution - 0161
  • Athens, Greece, 11527
    • Local Institution - 0135
  • Larissa, Greece, 41110
    • Local Institution - 0136
  • N.Kifissia, Greece, 14564
    • Local Institution - 0162
• Ireland
  • Dublin, Ireland, 00004
    • Local Institution - 0023
  • Dublin
    • Dublin 8, Dublin, Ireland
      • Local Institution - 0024
• Italy
  • Brescia, Italy, 25123
    • Local Institution - 0068
  • Catania, Italy, 95100
    • Aou Policlinico V. Emanuele Di Catania
  • Catanzaro, Italy, 88100
    • Azienda ospedaliero-universitaria Mater Domini
  • Lucca, Italy, 55100
    • Local Institution - 0050
  • Milano, Italy, 20141
    • Local Institution - 0115
  • Monza (MB), Italy, 20900
    • Local Institution - 0114
  • Perugia, Italy, 06129
    • Local Institution - 0048
• Japan
  • Wakayama, Japan, 641-8509
    • Local Institution - 0175
  • Aichi
    • Nagoya, Aichi, Japan, 4648681
      • Local Institution - 0204
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 8128582
      • Local Institution - 0212
    • Kurume-shi, Fukuoka, Japan, 8300011
      • Local Institution - 0211
  • Gunma
    • Ota, Gunma, Japan, 373-8550
      • Local Institution - 0197
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 0030804
      • Local Institution - 0195
  • Hyogo
    • Kobe, Hyogo, Japan, 6500047
      • Local Institution - 0206
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 9208641
      • Local Institution - 0203
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 2418515
      • Local Institution - 0217
    • Yokohama-Shi, Kanagawa, Japan, 2360051
      • Local Institution - 0201
    • Yokohama-shi, Kanagawa, Japan, 2210855
      • Local Institution - 0216
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9800873
      • Local Institution - 0196
  • Niigata
    • Niigata-shi, Niigata, Japan, 9518566
      • Local Institution - 0202
  • Osaka
    • Osaka-shi, Osaka, Japan, 5458586
      • Local Institution - 0205
    • Osakasayama, Osaka, Japan, 589-8511
      • Local Institution - 0210
  • Saitama
    • Hidaka-shi, Saitama, Japan, 3501298
      • Local Institution - 0198
    • Kitaadachi-gun, Saitama, Japan, 3620806
      • Local Institution - 0174
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Local Institution - 0199
    • Chuo-ku, Tokyo, Japan, 1040045
      • Local Institution - 0200
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-0241
      • Local Institution - 0232
• Korea, Republic of
  • Cheongju-si, Chungcheonbuk-do,, Korea, Republic of, 361-711
    • Local Institution - 0167
  • Seoul, Korea, Republic of, 03722
    • Local Institution - 0152
  • Seoul, Korea, Republic of, 06351
    • Local Institution - 0168
• Mexico
  • BAJA Californa SUR
    • La Paz, BAJA Californa SUR, Mexico, 23040
      • Local Institution - 0027
  • Distrito Federal
    • Df, Distrito Federal, Mexico, 06720
      • Local Institution - 0067
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Local Institution - 0080
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64060
      • Local Institution - 0014
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80230
      • Local Institution - 0015
• Netherlands
  • Amsterdam, Netherlands, 1081HV
    • Local Institution - 0006
  • Arnhem, Netherlands, 6815 AD
    • Local Institution - 0025
  • Leiden, Netherlands, 2333ZA
    • Local Institution - 0240
  • Maastrict, Netherlands, 6229 HX
    • Local Institution - 0005
  • Veldhoven, Netherlands, 5504 DB
    • Local Institution - 0026
• Poland
  • Bydgoszcz, Poland, 85796
    • Local Institution - 0107
  • Gdansk, Poland, 80-214
    • Local Institution - 0102
  • Krakow, Poland, 31-826
    • Local Institution - 0104
  • Tomaszow Mazowiecki, Poland, 97-200
    • Local Institution - 0235
• Puerto Rico
  • Hato Rey, Puerto Rico, 00917
    • Local Institution - 0120
  • San Juan, Puerto Rico, 917
    • GCM Medical Group, PSC - Hato Rey Site
• Romania
  • Bucharest, Romania, 022328
    • Local Institution - 0018
  • Bucuresti, Romania, 022548
    • Local Institution - 0222
  • Cluj-Napoca, Romania, 400015
    • Local Institution - 0019
  • Constanta, Romania, 900591
    • Local Institution - 0020
  • Craiova, Romania, 200542
    • Local Institution - 0017
  • Floresti/ Cluj, Romania, 407280
    • Local Institution - 0021
• Russian Federation
  • Moscow, Russian Federation, 125367
    • Local Institution
  • Moscow, Russian Federation, 115478
    • Local Institution
  • Moscow, Russian Federation, 105229
    • Local Institution
  • St. Petersburg, Russian Federation, 197758
    • Local Institution
• Singapore
  • Singapore, Singapore, 168583
    • Local Institution - 0171
• Spain
  • Barcelona, Spain, 8025
    • Local Institution - 0106
  • Hospitalet de Llobregat, Spain, 08907
    • Local Institution - 0099
  • Madrid, Spain, 28007
    • Local Institution - 0096
  • Madrid, Spain, 28046
    • Local Institution - 0095
  • Pamplona, Spain, 31008
    • Local Institution - 0098
  • Santiago de Compostela, Spain, 15706
    • Local Institution - 0105
  • Sevilla, Spain, 41013
    • Local Institution - 0097
  • Zaragoza, Spain, 50009
    • Local Institution - 0100
• Sweden
  • Stockholm, Sweden, 171 76
    • Local Institution - 0064
  • Vastra Gotalands Lan
    • Goteborg, Vastra Gotalands Lan, Sweden, 41345
      • Local Institution - 0065
• Switzerland
  • Basel, Switzerland, 4031
    • Local Institution - 0057
  • Lausanne, Switzerland, 1011
    • Local Institution - 0058
  • St.Gallen, Switzerland, 9007
    • Local Institution - 0059
  • Zuerich, Switzerland, 8091
    • Local Institution - 0056
• Taiwan
  • KaohsiungCity, Taiwan, 83301
    • Local Institution - 0208
  • New Taipei City, Taiwan, 235
    • Local Institution - 0214
  • Tainan, Taiwan, 704
    • Local Institution - 0209
  • Taipei, Taiwan, 10099
    • Local Institution - 0213
  • Taipei, Taiwan, 112
    • Local Institution - 0143
  • Taipei City, Taiwan, 100
    • Local Institution - 0133
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Local Institution - 0054
  • Bebington, United Kingdom, CH63 4JY
    • Local Institution - 0007
  • Hull, United Kingdom, HU16 5JQ
    • Local Institution - 0009
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2JB
      • Local Institution - 0010
  • Glamorgan
    • Swansea, Glamorgan, United Kingdom, SA2 8QA
      • Local Institution - 0012
• United States
  • California
    • La Jolla, California, United States, 92093
      • Local Institution - 0119
    • San Francisco, California, United States, 94115
      • Local Institution - 0207
    • San Francisco, California, United States, 94143
      • Local Institution - 0166
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Local Institution - 0129
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Local Institution - 0233
    • Orlando, Florida, United States, 32804
      • Local Institution - 0219
    • Pensacola, Florida, United States, 32504
      • Local Institution - 0039
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Local Institution - 0125
    • Augusta, Georgia, United States, 30912
      • Local Institution - 0165
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Local Institution - 0218
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Local Institution - 0108
  • Michigan
    • Traverse City, Michigan, United States, 49684
      • Local Institution - 0116
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Local Institution - 0053
    • Cincinnati, Ohio, United States, 45267
      • Local Institution - 0188
    • Cincinnati, Ohio, United States, 45242
      • Local Institution - 0131
    • Cleveland, Ohio, United States, 44106
      • Local Institution - 0112
    • Cleveland, Ohio, United States, 44106
      • Local Institution - 0124
    • Cleveland, Ohio, United States, 44109
      • Local Institution - 0047
    • Youngstown, Ohio, United States, 44501
      • Local Institution - 0123
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Local Institution - 0077
  • Texas
    • Austin, Texas, United States, 78731
      • Local Institution - 0191
    • Bryan, Texas, United States, 77802
      • Local Institution - 0079
    • Dallas, Texas, United States, 75203
      • Local Institution - 0130
  • Vermont
    • Burlington, Vermont, United States, 05405
      • Local Institution - 0071

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: nivolumab + CCRT + ipilimumab; Concurrent chemoradiotherapy (CCRT)	Biological: nivolumab; Specified dose on specified days; Biological: ipilimumab; Specified dose on specified days
Experimental: Arm B: nivolumab + CCRT; Concurrent chemoradiotherapy (CCRT)	Biological: nivolumab; Specified dose on specified days
Experimental: Arm C: CCRT + durvalumab; Concurrent chemoradiotherapy (CCRT)	Biological: durvalumab; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)
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.	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	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.	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	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.	From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)
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.	From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)
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.	From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)
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.	From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)
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.	From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)
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.	From randomization until metastases or death, whichever occurs first (up to approximately 61 months)
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.	From first dose (Day 1) till 30 days after the last dose (up to approximately 19 months)
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.	Baseline (Day 1) and Week 48

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): November 26, 2024

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 5, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Nivolumab; Durvalumab; Ipilimumab
• Other Study ID Numbers: CA209-73L; 2019-001222-98 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No