eligibility_summary
Adults (≥18) with adv/metastatic non‑sq NSCLC, activating EGFR mutation, progressed on 3rd‑gen EGFR‑TKI, no other systemic therapy, measurable disease, ECOG 0–1, life ≥3 mo, tissue available, adequate organ/cardiac (LVEF≥50%), not pregnant, contraception. Exclude SCLC/mixed/sq histology, recent therapy or TOP1‑ADC, active CNS mets, ILD, major CV/thrombotic/arrhythmia, severe infection/bleeding, effusions, vessel encasement, uncontrolled HTN/DM, HIV/HBV/HCV, recent vaccine/investigational drug, allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III randomized, open-label trial in EGFR-mutant, non-squamous NSCLC after progression on a third‑generation EGFR‑TKI. Drugs/interventions: 1) BL‑B01D1 (izalontamab brengitecan, BMS‑986507): a TROP2‑targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (camptothecin‑derived “brengitecan”) to TROP2‑expressing tumor cells, mechanism: antibody binding to TROP2 → internalization → payload release → TOP1 inhibition, DNA damage, and cell death (potential bystander effect). 2) Comparator: pemetrexed plus cisplatin or carboplatin, mechanisms: pemetrexed is an antifolate antimetabolite inhibiting thymidylate synthase, DHFR, and GARFT (blocks nucleotide synthesis), cisplatin/carboplatin are platinum DNA crosslinkers (disrupt DNA replication/repair). Targets: TROP2+ tumor cells, DNA replication/TOP1, folate-dependent nucleotide synthesis, DNA crosslink repair pathways.