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% to 49%

JRCT ID: jRCT2051240173

Registered date:29/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: NSQ, NSCLC
• Date of first enrollment: 29/10/2024
• Target sample size: 80
• Countries of recruitment: United States,Japan,China,Japan,Romania,Japan,Germany,Japan,Total 22 countries.,Japan
• Study type: Interventional

Intervention(s)

Arm A;Nivolumab/Relatlimab, Carboplatin, Pemetrexed, Cisplatin
Arm B;Pembrolizumab, Carboplatin, Pemetrexed, Cisplatin

Outcome(s)

• Primary Outcome: OS
• Secondary Outcome: PFS, ORR, DoR, Aes, SAEs, IMAEs, NSCLC-SAQ total score

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Qureshi Anila
• Secondary ID(s): NCT06561386