A Prospective Phase II Clinical Trial Evaluating Liquid Tumor-infiltrating Lymphocytes (L-TIL) in Combination With Tislelizumab as Adjuvant Therapy in Patients With Resectable Stage II to IIIB (N2) Non-small Cell Lung Cancer (NSCLC) Who Have Undergone Surgery Following Neoadjuvant Treatment With an Immune Checkpoint Inhibitor Plus Platinum-based Doublet Chemotherapy and Did Not Achieve a Pathological Complete Response (pCR)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- 2-year Disease Free Survival
研究概览
简要总结
This study evaluates the preliminary efficacy and safety of adjuvant therapy with liquid tumor-infiltrating lymphocytes (L-TIL) in combination with tislelizumab in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC) who underwent surgery after neoadjuvant treatment with an immune checkpoint inhibitor plus platinum-based doublet chemotherapy but did not achieve a pathological complete response (pCR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •Vaccination within 28 days prior to the first dose, except for inactivated vaccines;
- •Major surgery within 28 days prior to the first dose;
- •History of other malignancies within 5 years prior to screening;
- •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);
- •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;
- •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;
- •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;
- •Active infections requiring systemic anti-infective treatment;
- •Active gastrointestinal bleeding or contraindications to IL-2 use;
- •Previous bone marrow transplant or solid organ transplant;
- •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;
研究组 & 干预措施
L-TIL Cells Plus Tislelizumab
Participants will receive adjuvant therapy with liquid tumor-infiltrating lymphocytes (L-TIL) in combination with tislelizumab. Autologous peripheral blood TILs will be infused 4 times, each at a dose of ≥1 × 10⁹ cells, administered 2-3 days after each tislelizumab infusion. Tislelizumab will be given at 400 mg every 6 weeks for a total of 8 cycles of adjuvant treatment.
干预措施: L-TIL cells injection (Biological)
L-TIL Cells Plus Tislelizumab
Participants will receive adjuvant therapy with liquid tumor-infiltrating lymphocytes (L-TIL) in combination with tislelizumab. Autologous peripheral blood TILs will be infused 4 times, each at a dose of ≥1 × 10⁹ cells, administered 2-3 days after each tislelizumab infusion. Tislelizumab will be given at 400 mg every 6 weeks for a total of 8 cycles of adjuvant treatment.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
2-year Disease Free Survival
时间窗: 2 years
2-year DFS is defined as the proportion of patients who remain free of disease recurrence, second primary malignancy, or death from any cause at 24 months after surgery.
次要结局
- Disease free survival (DFS)(Up to 3 years)
- Overall survival (OS)(Up to 5 years)
- Adverse event (AE)(Up to 5 years)
- Locoregional Recurrence-Free Survival (LRFS)(Up to 3 years)
- Distant Metastasis-Free Survival (DMFS)(Up to 3 years)
- Lung Cancer-Specific Survival (LCSS)(Up to 5 years)