eligibility_summary
Eligible: Non-squamous NSCLC (stage IIIB/IIIC or IV) not fit for radical therapy, EGFR/ALK negative with no other approved targetable drivers, no prior systemic therapy, PD‑L1 TPS ≥1%, measurable disease, ECOG 0–1, life ≥12 wks, adequate organs. Exclude: SCLC/neuroendocrine/sarcomatoid or >10% squamous, prior immunotherapy, active second cancer, significant CV/thromboembolism, ILD/pneumonitis, active infection, HBV/HCV, HIV/syphilis, recent major surgery, pregnant/lactating.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 first-line NSCLC trial comparing: 1) SKB264 + pembrolizumab vs 2) pembrolizumab + chemotherapy (pemetrexed + carboplatin/cisplatin). Drugs and mechanisms: • SKB264: TROP2-targeted antibody-drug conjugate (ADC) delivering a topoisomerase I inhibitor payload, binds TROP2 on tumor cells, internalizes, releases cytotoxin to induce DNA damage/apoptosis (with potential bystander effect). • Pembrolizumab: anti–PD-1 monoclonal antibody (immune checkpoint inhibitor) that blocks PD-1 on T cells, restoring antitumor T-cell activity. • Pemetrexed: antifolate antimetabolite inhibiting thymidylate synthase, DHFR, and GARFT, suppressing nucleotide synthesis and tumor cell proliferation. • Carboplatin/cisplatin: platinum DNA crosslinkers causing DNA damage and apoptosis. Targets/pathways: TROP2-expressing tumor cells, PD-1/PD-L1 immune checkpoint on T cells, DNA replication/repair (Topo I), folate-dependent nucleotide synthesis, DNA crosslinking.