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%

NCT06561386
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,000
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Lead sponsor
Bristol-Myers Squibb
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Start date
2024-10-07
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Number of sites
322
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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 expression ≥ 1%
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Acronym
RELATIVITY1093
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Short 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%
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Official 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%
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2032-08-04
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First posted
2024-08-20
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Registry last updated
2026-08-17
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Primary completion date
2030-07-30
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Start date
2024-10-07
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Participants
1,000
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Participant count basis
Estimated
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Planned participants
1,000
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Protocol amendments
1
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Number of sites
322
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Bristol-Myers Squibb
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06561386
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ClinicalTrials.gov ID
NCT06561386
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Overall survival (OS) in randomized participants with PD-L1 1% to 49%

    Timeframe: Up to 5 years

  1. OS in randomized participants with PD-L1 ≥ 1%

    Timeframe: Up to 5 years

  2. 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)

    Timeframe: Up to 5 years

  3. Overall response rate (ORR)

    Timeframe: Up to 5 years

  4. Duration of response (DoR)

    Timeframe: Up to 5 years

  5. Number of participants with adverse events (AEs)

    Timeframe: Up to 2.5 years

  6. Number of participants with serious adverse events (SAEs)

    Timeframe: Up to 2.5 years

  7. Number of participants with immune-mediated adverse events (IMAEs)

    Timeframe: Up to 2.5 years

  8. The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score

    Timeframe: Up to 2 years

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
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  • Local Institution - 0487Mobile, United StatesNot yet recruiting
  • Southern Arizona VA Health Care SystemTucson, United StatesRecruiting
  • Local Institution - 0112Los Angeles, United StatesWithdrawn
  • University of California Davis (UC Davis) Comprehensive Cancer CenterSacramento, United StatesRecruiting
  • San Francisco Oncology AssociatesSan Francisco, United StatesRecruiting
  • UCLA Hematology/Oncology - Santa MonicaSanta Monica, United StatesRecruiting
  • Local Institution - 0500Grand Junction, United StatesNot yet recruiting
  • Local Institution - 0472Westminster, United StatesNot yet recruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer CenterMiami, United StatesRecruiting
  • Memorial Hospital WestPembroke Pines, United StatesRecruiting
  • Florida Cancer Specialists - NorthSt. Petersburg, United StatesRecruiting
  • Local Institution - 0477Tamarac, United StatesNot yet recruiting
  • Florida Cancer Specialists - EastWest Palm Beach, United StatesRecruiting
  • Local Institution - 0509Coeur d'Alene, United StatesNot yet recruiting
  • Affiliated Oncologists, LLCChicago Ridge, United StatesRecruiting
  • Cancer Center of KansasWichita, United StatesRecruiting
  • Saint Elizabeth Medical Center EdgewoodEdgewood, United StatesRecruiting
  • Baptist Health LexingtonLexington, United StatesRecruiting
  • Local Institution - 0502Paducah, United StatesNot yet recruiting
  • Local Institution - 0505Annapolis, United StatesNot yet recruiting
  • Local Institution - 0473Royal Oak, United StatesNot yet recruiting
  • Hattiesburg Clinic Hematology/OncologyHattiesburg, United StatesRecruiting
  • Local Institution - 0498Kansas City, United StatesNot yet recruiting
  • Local Institution - 0308Bozeman, United StatesCompleted
  • Renown Regional Medical CenterReno, United StatesRecruiting

And 297 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1306-8896
  • 2024-513682-40
Sources for references
clinicaltrials.gov

Related records

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Lead sponsors (1)

Conditions (1)

Targets (5)