eligibility_summary
Inclusion: Adults (≥18) with locally advanced/metastatic NSCLC, ECOG 0–1, ≥1 RECIST-measurable lesion, available tumor tissue, adequate organ function, contraception. Exclusion: prior systemic therapy (EGFR-TKI in B/C), recent anti-cancer therapy/surgery/trial, cardiac/QT/arrhythmia or severe lung disease (incl. ILD), active CNS mets, autoimmune disease, active HIV/TB/HBV/HCV, uncontrolled HTN/DM, effusions/bleeding, large-vessel invasion, transplant, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05880706 tests: 1) BL-B01D1 (izalontamab brengitecan, BMS-986507) — an intravenous bispecific antibody–drug conjugate (ADC) targeting EGFR and HER3. Upon binding, the ADC is internalized and releases brengitecan, a topoisomerase I–inhibitor payload, causing DNA damage and tumor cell death (with potential bystander effect). 2) Osimertinib — an oral, irreversible, third‑generation EGFR tyrosine‑kinase inhibitor that covalently inhibits mutant EGFR (including T790M), blocking downstream signaling. Target cells/pathways: EGFR‑ and/or HER3‑expressing NSCLC cells, EGFR/HER3 receptor signaling and downstream PI3K/AKT and MAPK pathways, topoisomerase I in proliferating tumor cells. The combo aims to suppress EGFR signaling while delivering cytotoxic DNA‑damaging payload to EGFR/HER3‑positive tumors.