eligibility_summary
Eligible: metastatic squamous/nonsquamous NSCLC, PD‑L1 ≥50% (central), no EGFR/ALK/ROS1 therapy, ECOG 0–1, life expectancy ≥3 mo, controlled HIV allowed. Exclude: small cell/mixed, prior systemic therapy for metastatic disease (prior PD‑1/PD‑L1 only if adjuvant/neoadjuvant >12 mo), recent RT/vaccine, immunodeficiency/steroids, active CNS mets, autoimmune disease on Tx, ILD/pneumonitis, infection, other active cancer, HBV/HCV coinfection, hypersensitivity, strong CYP3A4 drugs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06170788 is a Phase 3, first-line study in metastatic NSCLC (PD-L1 TPS ≥50%) comparing pembrolizumab plus sacituzumab tirumotecan (MK-2870/SKB264) vs pembrolizumab alone. Interventions/mechanisms: • Sacituzumab tirumotecan: TROP2-targeted antibody–drug conjugate (ADC). The anti-TROP2 monoclonal antibody delivers a topoisomerase I inhibitor payload to TROP2-expressing tumor cells, causing DNA damage and tumor cell death after internalization. • Pembrolizumab: anti–PD-1 monoclonal antibody checkpoint inhibitor that blocks PD-1 on T cells, reversing PD-1/PD-L1–mediated immunosuppression and restoring antitumor T-cell activity. Targets/cells/pathways: • Tumor cells expressing TROP2 (ADC-mediated cytotoxicity via topoisomerase I inhibition). • PD-1/PD-L1 axis on T cells and tumor/immune cells (checkpoint pathway). Primary goal: improve overall survival with the combination.