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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

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 Expression = 1%
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 = 1%
Secondary ID [1] 0 0
2024-513682-40
Secondary ID [2] 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) in randomized participants with PD-L1 1% to 49%
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
OS in randomized participants with PD-L1 = 1%
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Progression-free survival (PFS) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Overall response rate (ORR)
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Duration of response (DoR)
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
Number of participants with adverse events (AEs)
Timepoint [5] 0 0
Up to 2.5 years
Secondary outcome [6] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [6] 0 0
Up to 2.5 years
Secondary outcome [7] 0 0
Number of participants with immune-mediated adverse events (IMAEs)
Timepoint [7] 0 0
Up to 2.5 years
Secondary outcome [8] 0 0
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score
Timepoint [8] 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 no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
* Participants must have measurable PD-L1 = 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization.
* 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 a life expectancy of at least 3 months at the time of randomization.
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 be pregnant and/or breastfeeding.
* Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded.
* Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible.
* Participants must not have untreated central nervous system (CNS) metastases.
* Participants must not have leptomeningeal metastases (carcinomatous meningitis).
* Participants must not have concurrent malignancy requiring treatment.
* 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 to assist with management.
* Participants must not have a history of myocarditis.
* 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
7/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/11/2033
Actual
Sample size
Target
1000
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
GenesisCare North Shore - 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
Box Hill Hospital - 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
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United States of America
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Ciudad Autónoma De Buenos Aires
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Córdoba
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Santa Fe
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Austria
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Niederösterreich
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Austria
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Chile
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Zhejiang
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Copenhagen
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Haute-Garonne
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Hérault
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Bayern
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Nordrhein-Westfalen
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Sachsen
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Schleswig-Holstein
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Thüringen
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Bonn
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Essen
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Gauting
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West Bengal
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Verona
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Ravenna
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Chiba
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Fukuoka
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Hiroshima
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Hokkaido
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Kanagawa
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Kochi
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Saitama
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Akashi
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Fukushima
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Korea, Republic of
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Chungcheongbuk-do [Chungbuk]
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Korea, Republic of
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Incheon-gwangyeoksi [Incheon]
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Korea, Republic of
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Jeonranamdo
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Pusan-Kwangyokshi
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Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
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Jalisco
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Overijssel
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Groningen
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Auckland
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Dunedin
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Wellington
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Coimbra
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Porto
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València
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Basel
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Switzerland
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Münsterlingen
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei
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Taichung
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Taiwan
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Taipei
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Turkey
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Adana
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Ankara
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Turkey
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Istanbul
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United Kingdom
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Devon
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United Kingdom
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Dundee City
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United Kingdom
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Falkirk
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United Kingdom
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Glasgow City
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United Kingdom
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Kensington And Chelsea
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United Kingdom
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London, City Of
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United Kingdom
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Manchester
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United Kingdom
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Wirral

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
BMS Study Connect www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06561386