Studieoverzicht

Study name: 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% (RELATIVITY1093; CA224-1093)

Histology	NSCLC, only non-squamous
Tumor stage	Stage III - IV
NCT Id	NCT06561386
Host / recruiting site 1	LUMC	Enrollment	Recruiting
Therapy line	First line (1L)
PD-L1 expression	Low: 1 - 49%High: ≥50%
Design	A Phase 3, Randomized, Open-label Study
Intervention	Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy versus Pembrolizumab with Chemotherapy
Key outcome parameters	OS, PFS, ORR, safety
Key inclusion criteria	Histologically confirmed Stage IV or recurrent NSCLC of NSQ histology No prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. Tumor cell PD-L1 expression ≥ 1%
Key exclusion criteria	Symptomatic untreated CNS metastases or leptomeningeal metastases No EGFR, ALK, ROS-1, BRAF, RET, NTRK mutations Current of history of prior malignancy active within 2 years prior to treatment assignment requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of treatment assignment. symptomatic ascites or pleural effusion. A subject who is clinically stable per treating physicians discretion following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
Contact information	Log in voor de contactinformatie