This is a prospective, single-arm, multi-center Phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with SHR-A1811 in combination with Adebelimumab in patients with resectable, early-stage non-small cell lung cancer (NSCLC) harboring HER2 alterations.
Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);
Aged 18-75 years, male or female;
Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (AJCC staging system, version 9) NSCLC
HER2 alterations identified by histological specimens;
Known EGFR sensitizing mutations or ALK fusions.
Malignant pleural effusion. Drainable effusions during screening require thoracentesis to rule out malignancy.
Prior anticancer therapy (radiotherapy, chemotherapy, immunotherapy), except curatively treated NSCLC with ≥5 years recurrence-free. Anticancer Chinese herbal medicine is allowed if stopped ≥2 weeks prior.
Active or history of autoimmune diseases (e.g., uveitis, hepatitis, vasculitis, thyroiditis). Exceptions include: resolved childhood asthma, vitiligo, psoriasis, or alopecia without systemic treatment. Patients requiring bronchodilators are excluded.