eligibility_summary
Eligible: metastatic NSCLC, EGFR/ALK/ROS1 therapy not indicated, PD-L1 TPS ≥50% (central), life expectancy ≥3 mo. Exclude: second malignancy <3 y, prior systemic therapy for metastatic NSCLC, prior topo-I/Trop-2 or PD-1/PD-L1/PD-L2/T-cell agents, recent RT or high-dose lung RT, recent live vaccine or investigational therapy, significant cardiac disease, IBD, immunodeficiency/steroids, active CNS mets, severe hypersensitivity to pembro/sacituzumab, active autoimmune disease, pneumonitis/ILD, active infection, HIV/HBV/HCV, unresolved postsurgical issues.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 first-line trial in metastatic NSCLC with PD-L1 TPS ≥50% comparing pembrolizumab alone vs pembrolizumab plus sacituzumab govitecan. Pembrolizumab: monoclonal antibody immune checkpoint inhibitor (anti-PD-1) that blocks PD-1 from binding PD-L1/PD-L2 to restore antitumor T-cell activity. Sacituzumab govitecan (Trodelvy): antibody-drug conjugate targeting TROP-2 on tumor cells, delivers SN-38 (topoisomerase I inhibitor) to cause DNA damage and cell death, with potential bystander effect. Targets: PD-1/PD-L1 axis on T cells/tumor microenvironment and TROP-2–expressing tumor cells/DNA replication machinery.