eligibility_summary
Adults (≥18) with recurrent SCLC after PD‑1/PD‑L1 and platinum failure, ECOG 0–1, measurable disease, life expectancy ≥3 mo, adequate organs/LVEF ≥50%, prior AEs ≤grade 1, provide tumor tissue, contraception/negative pregnancy test. Exclude NSCLC/mixed, recent therapies, curative local options, prior TOP1 or anti‑EGFR/HER3, major cardiac/cerebrovascular/thrombotic disease, uncontrolled HTN/DM, ILD/pneumonitis, severe lung/CNS mets, infection, effusions, bleeding/wounds, GI disease, viral infection, vascular invasion, recent live vaccine.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III, randomized, open-label trial in recurrent small cell lung cancer after PD-1/PD-L1 and platinum failure, comparing: 1) BL-B01D1 (iza-bren, izalontamab brengitecan, BMS-986507): a bispecific antibody–drug conjugate (ADC) targeting EGFR and HER3 on tumor cells. Binding drives receptor-mediated internalization and intracellular release of a camptothecin-class topoisomerase I inhibitor payload (brengitecan), inducing DNA damage (S-phase cytotoxicity) with potential bystander effect, it also functionally blocks EGFR/HER3 signaling. Targets: EGFR/ERBB3-expressing tumor cells, EGFR/HER3 pathways, DNA replication via Topo I. 2) Topotecan: a small-molecule camptothecin Topo I inhibitor chemotherapy causing DNA strand breaks during replication. Targets: proliferating tumor cells’ Topo I/DNA repair machinery.