The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in China

Inclusion criteria

• Written informed consent provided
• Males or females aged ≥18 years
• Able to comply with the required protocol and follow-up procedures、
• Pathologically diagnosed of potentially resectable non-small cell lung cancer with stage II-IIIA (TNM 8th edition)
• Measurable disease must be characterized according to RECIST 1.1 criteria
• ECOG performance status 0-1
• Regardless of PD-L1 expression
• EGFR mutation (-) and ALK translocation (-)
• Pulmonary function could be well tolerated by lobectomy or pneumonectomy

Exclusion criteria

• EGFR mutation (+) or ALK translocation (+)
• Active Central nervous system (CNS) metastases
• Patients with active, known or suspected autoimmune disease.
• Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included
• Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment
• Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
• Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. Patients with other active malignancy requiring concurrent intervention and/ or concurrent treatment with other investigational drugs or anti-cancer therapy
• Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/ dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
• Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
• Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways Patients with positive test for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating active hepatitis
• Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Patients with history of allergy to study drug components excipients
• Women who are pregnant or in the period of breastfeeding
• Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study
• In case of doubt please contact trial team.