TALENT Study: Phase II Trial of Adjuvant L-TIL Plus Tislelizumab in Resectable NSCLC Without pCR After Neoadjuvant Chemoimmunotherapy

Prior treatment

• Vaccination within 28 days prior to the first dose, except for inactivated vaccines;
• Major surgery within 28 days prior to the first dose;
• Unstable or severe concurrent diseases within 6 months prior to the first dose, such as severe/unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction, pulmonary hypertension, life-threatening ventricular arrhythmias requiring maintenance therapy, stroke, and uncontrolled severe seizures;
• Arterial or venous thrombotic events occurring within 6 months prior to screening;
• History or CT findings indicating active tuberculosis within 1 year prior to enrollment that was untreated;
• Previous bone marrow transplant or solid organ transplant;

Other illness

• History of other malignancies within 5 years prior to screening;
• Clinically significant active pneumonia or other respiratory system diseases severely affecting lung function at screening;
• Active autoimmune diseases, history of autoimmune diseases, or conditions requiring systemic corticosteroids or immunosuppressive drugs;
• Active infections requiring systemic anti-infective treatment;
• Active gastrointestinal bleeding or contraindications to IL-2 use;
• Other serious acute or chronic medical or psychiatric illnesses (including suicidal ideation or behavior within one year) that may increase the risk associated with participation in the study or administration of the investigational treatment, interfere with the investigational treatment and follow-up, or affect the subject's compliance;

Lab values

• Congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (for inclusion criteria, ALT and AST levels must be within specified limits; for hepatitis B: HBV DNA \>10\^4/ml; for hepatitis C: HCV RNA \>10\^3/ml; for chronic hepatitis B carriers, HBV DNA \>2000 IU/ml (\>10\^4 copies/ml), antiviral treatment must be concurrently administered during the study period);

• Histologically or cytologically confirmed NSCLC with imaging indicating resectable stage II-IIIB (N2) disease according to the ninth edition of the AJCC lung cancer TNM staging system;
• No prior anti-tumor treatment;
• Negative for EGFR/ALK/ROS1 mutations;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Undergone 2-4 cycles of neoadjuvant therapy combining immunotherapy and chemotherapy, followed by surgical resection with R0 margins but without achieving a complete pathological response (non-pCR);
• Adequate organ function as defined below (without using any blood products or hematopoietic growth factors within 14 days):
  • Normal bone marrow reserve: neutrophil count ≥1.5×10⁹/L, lymphocyte count ≥0.6×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90g/L; Normal renal function: serum creatinine ≤1.5 mg/dL and/or creatinine clearance rate ≥60 mL/min; Normal liver function: total bilirubin ≤1.5 times ULN, AST and ALT ≤1.5 times ULN; Normal coagulation function: APTT ≤1.5 times ULN, INR ≤1.5 times ULN, PT ≤1.5 times ULN; Left ventricular ejection fraction (LVEF) ≥50% on echocardiography; Pulmonary function test showing FEV1 ≥60%;
• For non-surgically sterilized or women of childbearing potential, must agree to use medically approved contraception (such as an intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 3 months after the end of treatment; must have a negative serum or urine HCG test within 7 days prior to study entry; must not be breastfeeding;