eligibility_summary
Eligible: adults (≥18) with locally advanced/metastatic NSCLC harboring EGFR‑sensitizing mutation, ≥1 RECIST v1.1 measurable lesion, ECOG 0–1, life expectancy ≥3 mo, adequate organ/cardiac function (LVEF ≥50%), prior tox ≤G1, willing to provide tumor tissue, contraception. Exclude: prior systemic therapy/EGFR‑TKI, recent trial/radiation/surgery, major CV/QT/arrhythmia/thrombosis/bleeding, ILD/severe pulmonary, active infection (HBV/HCV/HIV/TB), autoimmune, CNS mets, other cancers, uncontrolled HTN/DM, pregnancy, live vaccines, transplant, drug allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single‑arm study testing two agents in EGFR‑mutant NSCLC: 1) BL‑B01D1 (izalontamab brengitecan, BMS‑986507), an antibody‑drug conjugate that is bispecific for EGFR and HER3. After binding these receptors on tumor cells, the ADC is internalized and releases a camptothecin‑class topoisomerase I inhibitor payload (“‑gitecan”), causing DNA damage and apoptosis. 2) Osimertinib mesylate, an oral third‑generation, irreversible small‑molecule EGFR tyrosine kinase inhibitor selective for activating and T790M resistance mutations. Targets/cells/pathways: EGFR‑mutant, HER3‑expressing epithelial tumor cells, ErbB family signaling (EGFR/HER3), with downstream MAPK and PI3K/AKT pathway inhibition via EGFR blockade, plus DNA replication/repair disruption via topoisomerase I inhibition from the ADC payload.