eligibility_summary
Inclusion: adults 18–75 with untreated, EGFR‑sensitizing stage IIIB/IIIC/IV NSCLC not curable, measurable disease, ECOG 0–1, tumor tissue, contraception, not pregnant, consent. Exclusion: prior MET or EGFR Ab/ADC, recent major surgery/TCM, clinically significant effusions, prohibited meds, residual ≥G2 AEs, other malignancy, active/untreated CNS mets, serious comorbidities (organ/CV/infectious, bleeding/thrombosis, ILD, neuro/psych), hypersensitivity, pregnancy/lactation, investigator‑judged risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06417008 tests HS-20117 plus aumolertinib vs aumolertinib alone in untreated, advanced EGFR-mutant (Ex19del/L858R) non-squamous NSCLC. HS-20117 (PM1080) is a fully human IgG1-like bispecific monoclonal antibody that binds EGFR and MET, providing dual receptor blockade to suppress EGFR signaling and MET-driven bypass pathways. Aumolertinib (HS-10296, almonertinib) is an oral, third-generation, irreversible small-molecule EGFR tyrosine kinase inhibitor selective for activating EGFR mutations, inhibiting downstream MAPK and PI3K/AKT signaling. Targeted cells/pathways: EGFR-mutant NSCLC tumor cells, receptor tyrosine kinases EGFR and MET, downstream proliferative/survival pathways. The combination aims to prevent/overcome MET-mediated resistance to EGFR inhibition.