eligibility_summary
Adults (≥18) with EGFR–wild-type locally advanced/metastatic NSCLC, ECOG 0–1, life expectancy ≥3 mo, measurable lesion, adequate organ/cardiac function (LVEF ≥50%), prior toxicities ≤G1, tumor tissue available, urine protein ≤2+ or <1000 mg/24h, contraception/negative pregnancy. Exclude: EGFR L858R/19del/T790M, SCLC/mixed, recent therapy, prior EGFR/HER3 or TOP1 ADC, major cardiac/cerebrovascular/thrombotic/QT issues, ILD, severe lung/CNS mets, infections/bleeding/effusions, GI disease, viral infections, prior SCT, recent trials/live vaccines, or other unsafe conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III, randomized, open-label study in EGFR–wild-type NSCLC post anti–PD-1/PD-L1 and platinum therapy compares BL-B01D1 vs docetaxel. BL-B01D1 (iza-bren, izalontamab brengitecan, BMS-986507) is a bispecific antibody–drug conjugate (ADC) targeting EGFR and HER3 on tumor cells. Upon binding and internalization, it releases a camptothecin-class topoisomerase I inhibitor payload (brengitecan), inducing DNA damage and cell death, with potential bystander effect. Comparator: Docetaxel, a cytotoxic taxane that stabilizes microtubules and blocks mitosis. Targeted cells/pathways: EGFR and HER3 (ErbB family) signaling on NSCLC cells, DNA topoisomerase I–dependent replication (ADC payload), and, in the control arm, microtubule dynamics in proliferating tumor cells. Both given IV q3 weeks until progression/toxicity.