The Efficacy and Safety of Adjuvant Immunotherapy After Pathological Complete Response Following Neoadjuvant Chemoimmunotherapy in Patients with Resectable NSCLC

Inclusion criteria

• 18 years ≤ age ≤ 80 years;
• Histologically or cytologically confirmed NSCLC;
• Resectable stage IB, II, IIIA, or IIIB (N2) NSCLC according to the staging criteria of the American Joint Committee on Cancer (8th edition);
• Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 at baseline;
• With measurable or evaluable diseases according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) at baseline;
• Achieving pathological complete response (pCR) after three cycles of neoadjuvant chemoimmunotherapy, which was assessed by independent pathological examination of surgical specimens;
• With or without adjuvant immunotherapy postoperatively;
• Signed and dated written informed consent provided by the patient prior to admission to the study.

Exclusion criteria

• EGFR or ALK aberrations positive;
• With primary/secondary immunodeficiency diseases or symptomatic interstitial lung diseases;
• With a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration;
• With other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drugs;
• Receipt of other investigational drugs during the observation period;
• Unable to follow the procedures required in the protocol due to any medical, mental or psychological conditions.