eligibility_summary
Include: 18–75, treatment‑naive, resectable stage II–IIIB NSCLC, HER2‑mutant, measurable (RECIST 1.1), ECOG 0–1, PET‑CT or CT+MRI, N2 confirmed by mediastinoscopy/EBUS, recent tissue (≤3 mo) and blood for MRD/biomarkers, fit for surgery, contraception. Exclude: unresectable/metastatic, driver mutations EGFR/ALK/KRAS‑sens/BRAF V600E/ROS1/RET/MET/NTRK, prior systemic therapy, pneumonitis, TB/HBV/HCV or HIV, live vaccine <30 d, prior PD‑1/PD‑L1/CTLA‑4, autoimmune disease, other cancers ≤5 y (low‑risk excepted).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Neoadjuvant regimen for resectable HER2‑mutant NSCLC: 1) Envafolimab: subcutaneous anti–PD‑L1 immune checkpoint inhibitor (humanized single‑domain monoclonal antibody) that blocks PD‑L1/PD‑1 to reinvigorate cytotoxic T cells. 2) Disitamab Vedotin (RC48): HER2‑targeted antibody–drug conjugate, anti‑HER2 mAb delivers MMAE (microtubule inhibitor) after internalization, causing mitotic arrest/apoptosis and potentially ADCC/bystander killing. 3) Carboplatin: platinum chemotherapy creating DNA crosslinks, triggering tumor cell death. Targets/pathways: HER2 on tumor cells (HER2 signaling), PD‑1/PD‑L1 checkpoint on tumor/immune cells, microtubules (via MMAE), and DNA damage/repair pathways (via carboplatin).