A Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy in Participants with Non-squamous Stage IV or Recurrent NSCLC and PD-L1 >= 1% (CA224-1093)
- Conditions
- NSQ, NSCLC
- Registration Number
- jRCT2051240173
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 88
-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% 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.
-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 leptomeningeal metastases (carcinomatous meningitis). -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.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Overall survival (OS) in randomized participants with PD-L1 1% to 49%
- Secondary Outcome Measures
Name Time Method IMAEs Immune-mediated adverse events
NSCLC-SAQ total score Non-small cell lung cancer symptom assessment questionnaire total score
OS in randomized participants with PD-L1 >= 1% Overall survival in randomized participants with PD-L1 expression level ≥ 1%
PFS Progression-free survival
ORR Objective response rate
DoR Duration of response
AEs Adverse events
SAEs Serious adverse events