Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04026412




Registration number
NCT04026412
Ethics application status
Date submitted
18/07/2019
Date registered
19/07/2019
Date last updated
30/07/2024

Titles & IDs
Public title
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
Scientific 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)
Secondary ID [1] 0 0
2019-001222-98
Secondary ID [2] 0 0
CA209-73L
Universal Trial Number (UTN)
Trial acronym
CheckMate73L
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - nivolumab
Treatment: Other - ipilimumab
Treatment: Other - durvalumab

Experimental: Arm A: nivolumab + CCRT + ipilimumab - Concurrent chemoradiotherapy (CCRT)

Experimental: Arm B: nivolumab + CCRT - Concurrent chemoradiotherapy (CCRT)

Experimental: Arm C: CCRT + durvalumab - Concurrent chemoradiotherapy (CCRT)


Treatment: Other: nivolumab
Specified dose on specified days

Treatment: Other: ipilimumab
Specified dose on specified days

Treatment: Other: durvalumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A vs Arm C
Timepoint [1] 0 0
Up to 7 years
Secondary outcome [1] 0 0
Overall Survival (OS) for Arm A vs Arm C
Timepoint [1] 0 0
Up to 7 years
Secondary outcome [2] 0 0
PFS by RECIST 1.1 per BICR for Arm B vs Arm C
Timepoint [2] 0 0
Up to 7 years
Secondary outcome [3] 0 0
OS for Arm B vs Arm C
Timepoint [3] 0 0
Up to 7 years
Secondary outcome [4] 0 0
PFS by RECIST 1.1 per BICR for Arm A vs Arm B
Timepoint [4] 0 0
Up to 7 years
Secondary outcome [5] 0 0
OS for Arm A vs Arm B
Timepoint [5] 0 0
Up to 7 years
Secondary outcome [6] 0 0
Objective Response Rate (ORR) by RECIST 1.1 per BICR
Timepoint [6] 0 0
Up to 7 years
Secondary outcome [7] 0 0
Duration of Response (DoR) by RECIST 1.1 per BICR
Timepoint [7] 0 0
Up to 7 years
Secondary outcome [8] 0 0
Time to Response (TTR) by RECIST 1.1 per BICR
Timepoint [8] 0 0
Up to 7 years
Secondary outcome [9] 0 0
PFS by RECIST 1.1 per Investigator assessment
Timepoint [9] 0 0
Up to 7 years
Secondary outcome [10] 0 0
ORR by RECIST 1.1 per Investigator assessment
Timepoint [10] 0 0
Up to 7 years
Secondary outcome [11] 0 0
DoR by RECIST 1.1 per Investigator assessment
Timepoint [11] 0 0
Up to 7 years
Secondary outcome [12] 0 0
TTR by RECIST 1.1 per Investigator assessment
Timepoint [12] 0 0
Up to 7 years
Secondary outcome [13] 0 0
Time to Death or Distant Metastases (TTDM) by RECIST 1.1 per Investigator assessment
Timepoint [13] 0 0
Up to 7 years
Secondary outcome [14] 0 0
Incidence of Adverse Events (AEs)
Timepoint [14] 0 0
Up to 7 years
Secondary outcome [15] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [15] 0 0
Up to 7 years
Secondary outcome [16] 0 0
Incidence of select AEs
Timepoint [16] 0 0
Up to 7 years
Secondary outcome [17] 0 0
Proportion of participants without symptom deterioration based on NSCLC-SAQ
Timepoint [17] 0 0
Up to 7 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/09/2024
Actual
Sample size
Target
Accrual to date
Final
925
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0031 - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - 0134 - Gosford
Recruitment hospital [3] 0 0
Local Institution - 0033 - Kingswood
Recruitment hospital [4] 0 0
Local Institution - 0029 - Greenslopes
Recruitment hospital [5] 0 0
Local Institution - 0028 - Adelaide
Recruitment hospital [6] 0 0
Local Institution - 0224 - Ballarat Central
Recruitment hospital [7] 0 0
Local Institution - 0052 - Melbourne
Recruitment hospital [8] 0 0
Local Institution - Melbourne
Recruitment hospital [9] 0 0
Local Institution - 0030 - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3199 - Melbourne
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
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United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Georgia
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United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Vermont
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Cordoba
Country [14] 0 0
Argentina
State/province [14] 0 0
Distrito Federal
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
Belgium
State/province [17] 0 0
Liege
Country [18] 0 0
Belgium
State/province [18] 0 0
Yvoir
Country [19] 0 0
Brazil
State/province [19] 0 0
Minas Gerais
Country [20] 0 0
Brazil
State/province [20] 0 0
RIO Grande DO SUL
Country [21] 0 0
Brazil
State/province [21] 0 0
Santa Catarina
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Brazil
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SAO Paulo
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Brazil
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Rio de Janeiro
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Metropolitana
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Chile
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Valparaiso
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China
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BEI
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China
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Chongqing
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China
State/province [30] 0 0
Fujian
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China
State/province [31] 0 0
Guizhou
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
State/province [36] 0 0
Jilin
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China
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Shandong
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China
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Shanghai
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China
State/province [39] 0 0
Sichuan
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China
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Zhejiang
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France
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Bordeaux
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France
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Dijon
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France
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Lyon
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France
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Montpellier
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France
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Nantes
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France
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Paris Cedex 14
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France
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Paris Cedex 5
Country [48] 0 0
France
State/province [48] 0 0
Paris
Country [49] 0 0
France
State/province [49] 0 0
Tours Cedex 09
Country [50] 0 0
Germany
State/province [50] 0 0
Berlin
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Germany
State/province [51] 0 0
Essen
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Germany
State/province [52] 0 0
Grosshansdorf
Country [53] 0 0
Germany
State/province [53] 0 0
Hamm
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Germany
State/province [54] 0 0
Heidelberg
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Germany
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Immenhausen
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Germany
State/province [56] 0 0
Kempten
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Germany
State/province [57] 0 0
Loewenstein
Country [58] 0 0
Germany
State/province [58] 0 0
Mainz
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Germany
State/province [59] 0 0
Stuttgart
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Greece
State/province [60] 0 0
Athens
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Greece
State/province [61] 0 0
Larissa
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Greece
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N.Kifissia
Country [63] 0 0
Ireland
State/province [63] 0 0
Dublin
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Italy
State/province [64] 0 0
Brescia
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Italy
State/province [65] 0 0
Catania
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Italy
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Catanzaro
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Italy
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Lucca
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Italy
State/province [68] 0 0
Milano
Country [69] 0 0
Italy
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Monza (MB)
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Italy
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Perugia
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Gunma
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Yamaguchi
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Japan
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Wakayama
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Korea, Republic of
State/province [85] 0 0
Cheongju-si, Chungcheonbuk-do,
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Korea, Republic of
State/province [86] 0 0
Seoul
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Mexico
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BAJA Californa SUR
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Nuevo LEON
Country [91] 0 0
Mexico
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Sinaloa
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Netherlands
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Amsterdam
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Netherlands
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Arnhem
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Netherlands
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Leiden
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Netherlands
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Maastrict
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Netherlands
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Veldhoven
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Tomaszow Mazowiecki
Country [101] 0 0
Puerto Rico
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Hato Rey
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Puerto Rico
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San Juan
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
Country [106] 0 0
Romania
State/province [106] 0 0
Constanta
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Romania
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Craiova
Country [108] 0 0
Romania
State/province [108] 0 0
Floresti/ Cluj
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Moscow
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Hospitalet de Llobregat
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Santiago de Compostela
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Spain
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Sevilla
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Spain
State/province [118] 0 0
Zaragoza
Country [119] 0 0
Sweden
State/province [119] 0 0
Vastra Gotalands Lan
Country [120] 0 0
Sweden
State/province [120] 0 0
Stockholm
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Switzerland
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Basel
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Switzerland
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Lausanne
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Switzerland
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St.Gallen
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Switzerland
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Zuerich
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Taiwan
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KaohsiungCity
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Taiwan
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New Taipei City
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Taiwan
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Tainan
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Taiwan
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Taipei City
Country [129] 0 0
Taiwan
State/province [129] 0 0
Taipei
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United Kingdom
State/province [130] 0 0
Dorset
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United Kingdom
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Glamorgan
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United Kingdom
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Aberdeen
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Bebington
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Hull

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04026412