eligibility_summary
Eligible: adv/met non‑sq NSCLC with target mutations, RECIST PD, measurable, prior 1–2 EGFR TKIs (incl 3rd‑gen if T790M) and platinum, tissue available, AEs ≤G1, controlled HBV/HIV, ECOG 0–1. Exclude: squamous/small‑cell mix, IBD, ≥G2 neuropathy, severe ocular/CV/CVA dz, T790M w/o 3rd‑gen TKI, recent therapy/vaccine/RT (lung >30 Gy/6 mo), prior TROP2 or topo‑I ADC, recent investigational, active cancer/infection, pneumonitis/ILD, active CNS mets (treated/stable ok), HIV w/Kaposi/MCD, concurrent HBV+HCV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
- Intervention: Sacituzumab tirumotecan (MK-2870/SKB264), a TROP2-directed antibody-drug conjugate (biologic). Mechanism: a humanized anti-TROP2 monoclonal antibody binds TROP2 on tumor cells, is internalized, and releases a topoisomerase I inhibitor payload, inducing DNA damage and cell death. - Comparators: Docetaxel (taxane cytotoxic, stabilizes microtubules to block mitosis) or Pemetrexed (antifolate antimetabolite, inhibits thymidylate synthase, DHFR, and related folate-dependent enzymes to impair DNA/RNA synthesis). - Cells/pathways targeted: TROP2-expressing NSCLC cells, DNA topoisomerase I–mediated replication, microtubule dynamics, folate-dependent nucleotide synthesis. Studied in previously treated advanced/metastatic nonsquamous NSCLC harboring EGFR mutations or other driver alterations (ALK, ROS1, BRAF V600E, NTRK, METex14, RET, uncommon EGFR).