eligibility_summary
Adults ≥18 with locally advanced/metastatic NSCLC: EGFR WT/ALK− or EGFR‑mutant (tx‑naive or after EGFR‑TKI), no prior systemic therapy if no actionable EGFR/ALK. Tumor tissue available, measurable disease (RECIST v1.1), ECOG 0–1, life ≥3 mo, adequate organs, recovered AEs, contraception, consent. Exclude mixed SCLC, other malignancy, active CNS/meningeal mets, ≥G2 neuropathy, major TE/CV risk, IBD, ILD/pneumonitis, uncontrolled disease, active autoimmune, HBV/HCV/HIV/TB, allogeneic transplant, pregnancy, rapid decline.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, open-label NSCLC trial of SKB264 (MK-2870, sacituzumab tirumotecan), a TROP2-targeted antibody–drug conjugate (ADC) delivering a topoisomerase I inhibitor to TROP2-expressing tumor cells. Tested as monotherapy and in combinations: pembrolizumab (anti–PD-1 monoclonal antibody checkpoint inhibitor), carboplatin (platinum DNA–crosslinking chemotherapy), and osimertinib (EGFR tyrosine kinase inhibitor). Targets/pathways: TROP2 on tumor cells (ADC-mediated internalization and topo I–induced DNA damage), PD-1/PD-L1 immune checkpoint on T cells/tumor microenvironment (T-cell activation), DNA replication/repair via platinum crosslinks, and EGFR-mutant signaling in tumor cells. Cohorts span EGFR/ALK–negative 1L, EGFR-mutant 1L (with osimertinib), post–EGFR-TKI (with carboplatin), and 2L/3L SKB264 monotherapy.