eligibility_summary
Eligible: ≥18 with advanced/metastatic NSCLC not suitable for curative tx. Biomarkers: 1) HER2 alteration, no other drivers, 2) EGFR mutation + HER2, 3) HER2 mutation, no other drivers. Lines: 1–2 untreated, 3 ≥1 prior standard line or intolerant. Also DFI ≥6 mo, RECIST 1.1 measurable lesion, ECOG 0–1, life expectancy ≥3 mo. Exclude: symptomatic CNS/leptomeningeal mets, autoimmune/immunodeficiency/HIV/transplant, active HBV/HCV/syphilis, major surgery/trauma <3 wks, drug allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, parallel-arm study in advanced NSCLC with HER2 alterations. Interventions: 1) Disitamab vedotin (RC48), a HER2-targeted antibody-drug conjugate carrying MMAE, it binds HER2 on tumor cells, is internalized, and releases a microtubule inhibitor to induce cytotoxicity (bystander effect possible). 2) Tislelizumab, an anti-PD-1 monoclonal antibody (immune checkpoint inhibitor) to restore T-cell activity, given with carboplatin, a platinum chemotherapy that crosslinks DNA. 3) Furmonertinib, a third-generation irreversible EGFR TKI, combined with RC48 in 1L EGFR-mutant/HER2-altered and later-line HER2-mutant settings. Targets/pathways: HER2/ERBB2 on tumor cells, EGFR signaling (EGFR-mutant disease), PD-1 on T cells, microtubules (MMAE payload), DNA crosslinking (carboplatin).