eligibility_summary
Inclusion: Adults ≥18 with ES‑SCLC, adequate tumor tissue, 1 prior platinum line (≥2 cycles, ≥30‑d chemo‑free), measurable (RECIST 1.1), progression, ECOG 0–1, no CNS/leptomeningeal mets and stable ≥2 wks off steroids/anticonvulsants. Exclusion: prior B7‑H3 therapy or topo I inhibitors, exatecan‑ADC stopped for toxicity, inadequate washout, CVA/TIA/arterial event ≤6 mo, uncontrolled CV disease, corneal disease, ILD/pneumonitis, severe pulmonary compromise or O2 need.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06203210 (Phase 3) in relapsed SCLC. Interventions: Ifinatamab deruxtecan (I‑DXd) 12 mg/kg IV q3w vs physician’s choice: topotecan, lurbinectedin, or amrubicin. Mechanisms/types: I‑DXd is a B7‑H3–targeted antibody–drug conjugate (human IgG1 mAb to B7‑H3/CD276) carrying a deruxtecan payload (exatecan‑derived small‑molecule topoisomerase I inhibitor). Binding to B7‑H3 on SCLC cells triggers internalization and release of the payload, causing topo‑I–mediated DNA damage/apoptosis (with potential bystander effect). Comparators: topotecan (small‑molecule camptothecin, topo‑I inhibitor), lurbinectedin (small‑molecule DNA minor‑groove binder, inhibits RNA Pol II–dependent transcription, induces DNA breaks), amrubicin (anthracycline chemo, topo‑II inhibitor/DNA intercalator). Targets: B7‑H3 on tumor cells, topoisomerases I/II and transcription machinery in SCLC.