Efficacy and Safety of Toripalimab Adjuvant Therapy in High-risk Stage IA2-IB NSCLC With no Driver Alterations (EGFR or ALK) After Complete Resection: a Prospective, Single-arm Study
This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors.
• The subjects will voluntarily sign the informed consent in person, and provide the informed consent before any specific study procedures;
• Male and female, ≥18 years old;
• Primary non-squamous NSCLC confirmed histologically by the central laboratory;
• The subject was clinically confirmed as stage IA2-IB by imaging with tumor lesion size \> 2 cm;
• As confirmed by the central laboratory, the tumor contains no common EGFR mutations and ALK fusion variants;
• The primary NSCLC must be completely resected by surgery, and all lesions must be removed at the end of the surgery.All surgical margins must be negative. Lobectomy can be done with open surgery or thoracoscopic (VATS);
• Central laboratory pathology confirmed solid and/or micropapillary component ≥10%, and/or STAS, and/or pleural invasion, and/or poorly differentiated, and/or complex glands ≥ 10%; PD-L1 TPS ≥ 1% in tumor tissue;
• WHO physical status score is 0\
⁃ 1;
• Paraffin-embedded sections (10-15 sheets), or wax blocks or fresh frozen tissue for surgical resection of the lesion should be provided;
• Adequate bone marrow reserve or organ function (demonstrated by any of the following laboratory values: absolute neutrophil count ≥1.5×10⁹/L; Platelet count ≥100×10⁹/L; Hemoglobin ≥90 g/L; Alanine aminotransferase ≤ 2.5 ULN; Aspartate aminotransferase ≤2.5 times ULN; Total bilirubin ≤ 1.5 ULN; Serum creatinine ≤1.5 ULN with creatinine clearance ≥60 mL/min \[as measured or calculated by Cockcroft and Gault formulas\]);
• At least 2 weeks prior to initiation of the study drug, female subjects should be using highly effective contraceptive methods, pregnancy tests must be negative, and there must be no ongoing breastfeeding prior to initiation of the drug
• Subjects voluntarily join this study, with good compliance and cooperation in safety and survival follow-up.