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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06561386




Registration number
NCT06561386
Ethics application status
Date submitted
16/08/2024
Date registered
20/08/2024
Date last updated
26/11/2024

Titles & IDs
Public title
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 1-49%
Scientific title
A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression of 1% to 49%
Secondary ID [1] 0 0
CA224-1093
Universal Trial Number (UTN)
Trial acronym
RELATIVITY1093
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 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: Drugs - Nivolumab
Treatment: Drugs - Relatlimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin

Experimental: Arm A -

Active comparator: Arm B -


Treatment: Drugs: Nivolumab
Specified dose on specified days

Treatment: Drugs: Relatlimab
Specified dose on specified days

Treatment: Drugs: Pembrolizumab
Specified dose on specified days

Treatment: Drugs: Carboplatin
Specified dose on specified days

Treatment: Drugs: Pemetrexed
Specified dose on specified days

Treatment: Drugs: Cisplatin
Specified dose on specified days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Overall response rate (ORR)
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Duration of response (DoR)
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Number of participants with adverse events (AEs)
Timepoint [4] 0 0
Up to 2.5 years
Secondary outcome [5] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [5] 0 0
Up to 2.5 years
Secondary outcome [6] 0 0
Number of participants with immune-mediated adverse events (IMAEs)
Timepoint [6] 0 0
Up to 2.5 years
Secondary outcome [7] 0 0
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score
Timepoint [7] 0 0
Up to 2 years

Eligibility
Key inclusion criteria
Inclusion Criteria

* Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with tumor cell PD-L1 expression 1% to 49% as determined by a central laboratory
* Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
* Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of = 1 at screening.
* Participants must have no prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Participants must not have epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations and neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations.
* Participants must not have untreated central nervous system (CNS) metastases.
* Participants must not have concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization.
* Participants must not have an active autoimmune disease.
* Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids.
* Participants must not have a history of myocarditis, regardless of etiology.
* Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
* 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Local Institution - 0061 - St Leonards
Recruitment hospital [3] 0 0
Local Institution - 0243 - Brisbane
Recruitment hospital [4] 0 0
Gallipoli Medical Research Ltd - Brisbane
Recruitment hospital [5] 0 0
Local Institution - 0057 - Elizabeth Vale
Recruitment hospital [6] 0 0
Local Institution - 0054 - Box Hill
Recruitment hospital [7] 0 0
Local Institution - 0053 - Murdoch
Recruitment hospital [8] 0 0
St. John of God Murdoch Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4032 - Brisbane
Recruitment postcode(s) [4] 0 0
4120 - Brisbane
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Florida
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United States of America
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Kentucky
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United States of America
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Mississippi
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United States of America
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Montana
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United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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Ohio
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United States of America
State/province [12] 0 0
Pennsylvania
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United States of America
State/province [13] 0 0
Texas
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United States of America
State/province [14] 0 0
Utah
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Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad Autónoma De Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Córdoba
Country [18] 0 0
Argentina
State/province [18] 0 0
Santa Fe
Country [19] 0 0
Austria
State/province [19] 0 0
Niederösterreich
Country [20] 0 0
Austria
State/province [20] 0 0
Oberösterreich
Country [21] 0 0
Austria
State/province [21] 0 0
Feldkirch
Country [22] 0 0
Austria
State/province [22] 0 0
Wien
Country [23] 0 0
Belgium
State/province [23] 0 0
Bruxelles-Capitale, Région De
Country [24] 0 0
Belgium
State/province [24] 0 0
Limburg
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Belgium
State/province [25] 0 0
Namur
Country [26] 0 0
Belgium
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West-Vlaanderen
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Brazil
State/province [27] 0 0
Minas Gerais
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Brazil
State/province [28] 0 0
Rio Grande Do Norte
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio Grande Do Sul
Country [30] 0 0
Brazil
State/province [30] 0 0
Santa Catarina
Country [31] 0 0
Brazil
State/province [31] 0 0
São Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio de Janeiro
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Chile
State/province [33] 0 0
Región Metropolitana De Santiago
Country [34] 0 0
China
State/province [34] 0 0
Anhui
Country [35] 0 0
China
State/province [35] 0 0
Beijing
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China
State/province [36] 0 0
Chongqing
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China
State/province [37] 0 0
Fujian
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China
State/province [38] 0 0
Guangdong
Country [39] 0 0
China
State/province [39] 0 0
Guangxi
Country [40] 0 0
China
State/province [40] 0 0
Heilongjiang
Country [41] 0 0
China
State/province [41] 0 0
Henan
Country [42] 0 0
China
State/province [42] 0 0
Hubei
Country [43] 0 0
China
State/province [43] 0 0
Hunan
Country [44] 0 0
China
State/province [44] 0 0
Jiangsu
Country [45] 0 0
China
State/province [45] 0 0
Liaoning
Country [46] 0 0
China
State/province [46] 0 0
Shandong
Country [47] 0 0
China
State/province [47] 0 0
Shanghai
Country [48] 0 0
China
State/province [48] 0 0
Sichuan
Country [49] 0 0
China
State/province [49] 0 0
Tianjin
Country [50] 0 0
China
State/province [50] 0 0
Zhejiang
Country [51] 0 0
Denmark
State/province [51] 0 0
Midtjylland
Country [52] 0 0
Denmark
State/province [52] 0 0
Syddanmark
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Denmark
State/province [53] 0 0
Copenhagen
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France
State/province [54] 0 0
Hérault
Country [55] 0 0
France
State/province [55] 0 0
Ille-et-Vilaine
Country [56] 0 0
France
State/province [56] 0 0
Nord-Pas-de-Calais
Country [57] 0 0
France
State/province [57] 0 0
Provence-Alpes-Côte-d'Azur
Country [58] 0 0
France
State/province [58] 0 0
Rhône
Country [59] 0 0
France
State/province [59] 0 0
Marseille
Country [60] 0 0
France
State/province [60] 0 0
Paris
Country [61] 0 0
Germany
State/province [61] 0 0
Baden-Württemberg
Country [62] 0 0
Germany
State/province [62] 0 0
Bayern
Country [63] 0 0
Germany
State/province [63] 0 0
Hessen
Country [64] 0 0
Germany
State/province [64] 0 0
Schleswig-Holstein
Country [65] 0 0
Germany
State/province [65] 0 0
Thüringen
Country [66] 0 0
Germany
State/province [66] 0 0
Berlin
Country [67] 0 0
Germany
State/province [67] 0 0
Bonn
Country [68] 0 0
Germany
State/province [68] 0 0
Essen
Country [69] 0 0
Germany
State/province [69] 0 0
Gauting
Country [70] 0 0
Germany
State/province [70] 0 0
Heidelberg
Country [71] 0 0
India
State/province [71] 0 0
Delhi
Country [72] 0 0
India
State/province [72] 0 0
Karnataka
Country [73] 0 0
India
State/province [73] 0 0
Kerala
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India
State/province [74] 0 0
Maharashtra
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India
State/province [75] 0 0
West Bengal
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Ireland
State/province [76] 0 0
Dublin
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Italy
State/province [77] 0 0
Lombardia
Country [78] 0 0
Italy
State/province [78] 0 0
Napoli
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Italy
State/province [79] 0 0
Puglia
Country [80] 0 0
Italy
State/province [80] 0 0
Roma
Country [81] 0 0
Italy
State/province [81] 0 0
Verona
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Japan
State/province [82] 0 0
Chiba
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Hokkaido
Country [86] 0 0
Japan
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Kanagawa
Country [87] 0 0
Japan
State/province [87] 0 0
Miyagi
Country [88] 0 0
Japan
State/province [88] 0 0
Nara
Country [89] 0 0
Japan
State/province [89] 0 0
Niigata
Country [90] 0 0
Japan
State/province [90] 0 0
Okayama
Country [91] 0 0
Japan
State/province [91] 0 0
Osaka
Country [92] 0 0
Japan
State/province [92] 0 0
Saitama
Country [93] 0 0
Japan
State/province [93] 0 0
Shizuoka
Country [94] 0 0
Japan
State/province [94] 0 0
Tokyo
Country [95] 0 0
Japan
State/province [95] 0 0
Akashi
Country [96] 0 0
Japan
State/province [96] 0 0
Fukushima
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Chungcheongbuk-do [Chungbuk]
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Incheon-gwangyeoksi [Incheon]
Country [99] 0 0
Korea, Republic of
State/province [99] 0 0
Kyonggi-do
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Seoul-teukbyeolsi [Seoul]
Country [101] 0 0
Mexico
State/province [101] 0 0
Distrito Federal
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Mexico
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Jalisco
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Mexico
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Querétaro
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Mexico
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San Luis Potosí
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Netherlands
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Gelderland
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Netherlands
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Limburg
Country [107] 0 0
Netherlands
State/province [107] 0 0
Noord-Brabant
Country [108] 0 0
Netherlands
State/province [108] 0 0
Overijssel
Country [109] 0 0
Netherlands
State/province [109] 0 0
Zuid-Holland
Country [110] 0 0
Netherlands
State/province [110] 0 0
Arnhem
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Netherlands
State/province [111] 0 0
Groningen
Country [112] 0 0
Poland
State/province [112] 0 0
Mazowieckie
Country [113] 0 0
Poland
State/province [113] 0 0
Pomorskie
Country [114] 0 0
Poland
State/province [114] 0 0
Wielkopolskie
Country [115] 0 0
Poland
State/province [115] 0 0
Zachodniopomorskie
Country [116] 0 0
Poland
State/province [116] 0 0
Bydgoszcz
Country [117] 0 0
Poland
State/province [117] 0 0
Lódzkie
Country [118] 0 0
Romania
State/province [118] 0 0
Bucure?ti
Country [119] 0 0
Romania
State/province [119] 0 0
Cluj
Country [120] 0 0
Romania
State/province [120] 0 0
Dolj
Country [121] 0 0
Romania
State/province [121] 0 0
Prahova
Country [122] 0 0
Romania
State/province [122] 0 0
Ia?i
Country [123] 0 0
Spain
State/province [123] 0 0
A Coruña [La Coruña]
Country [124] 0 0
Spain
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Barcelona [Barcelona]
Country [125] 0 0
Spain
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Catalunya [Cataluña]
Country [126] 0 0
Spain
State/province [126] 0 0
Madrid, Comunidad De
Country [127] 0 0
Spain
State/province [127] 0 0
Málaga
Country [128] 0 0
Spain
State/province [128] 0 0
Sevilla
Country [129] 0 0
Spain
State/province [129] 0 0
València
Country [130] 0 0
Switzerland
State/province [130] 0 0
Sankt Gallen
Country [131] 0 0
Switzerland
State/province [131] 0 0
Ticino
Country [132] 0 0
Switzerland
State/province [132] 0 0
Vaud
Country [133] 0 0
Switzerland
State/province [133] 0 0
Basel
Country [134] 0 0
Taiwan
State/province [134] 0 0
New Taipei
Country [135] 0 0
Taiwan
State/province [135] 0 0
Taichung
Country [136] 0 0
Taiwan
State/province [136] 0 0
Taipei
Country [137] 0 0
Turkey
State/province [137] 0 0
Adana
Country [138] 0 0
Turkey
State/province [138] 0 0
Ankara
Country [139] 0 0
Turkey
State/province [139] 0 0
Istanbul
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Falkirk
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Glasgow City
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Kensington And Chelsea
Country [143] 0 0
United Kingdom
State/province [143] 0 0
London, City Of
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Manchester
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Wirral

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 1-49%
Trial website
https://clinicaltrials.gov/study/NCT06561386
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
BMS Study Connect www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06561386