A Randomized Phase 2 Study of Hypofractionated Concurrent Chemoradiotherapy Combined With Tislelizumab and Surufatinib in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
研究概览
简要总结
This phase II trial employs a prospective, randomized, parallel-group design to evaluate the efficacy and safety of hypofractionated radiotherapy combined with tislelizumab and surufatinib. Eligible patients are randomly assigned to one of two arms: Experimental Group A receives hypofractionated chemoradiotherapy plus concurrent tislelizumab and surufatinib, followed by consolidation therapy with tislelizumab plus surufatinib; Experimental Group B receives the same hypofractionated chemoradiotherapy plus concurrent tislelizumab alone, followed by tislelizumab consolidation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 to 75 years or older;
- •Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC);
- •Unresectable Stage III disease according to AJCC 8th staging system;
- •Negative for known driver gene mutations；
- •Newly diagnosed patients or patients treated with ≤ 4 cycles of chemotherapy combined with or without immunotherapy;
- •Expected survival ≥ 12 weeks;
- •WHO Performance Status (PS) score of 0 or 1;
- •Female subjects must not be breastfeeding;
- •Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment and for 5 months after the last dose of study drug (i.e., 30 days [one ovulation cycle] plus approximately five half-lives of the study drug);
- •Adequate organ and bone marrow function as defined by the following criteria:
- •Forced Expiratory Volume in 1 second (FEV1) ≥ 800 mL;
- •Absolute neutrophil count ≥ 1.5 × 10⁹/L;
- •Platelets ≥ 100 × 10⁹/L;
- •Hemoglobin ≥ 9.0 g/dL;
- •Creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976);
- •Serum bilirubin ≤ 1.5 × upper limit of normal (ULN);
- •AST and ALT ≤ 2.5 × ULN.
排除标准
- •Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;
- •Mixed small cell and non-small cell lung cancer histology;
- •Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access;
- •Active or prior documented autoimmune disease within the past 2 years;
- •Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);
- •History of primary immunodeficiency;
- •History of organ transplant that requires therapeutic immunosuppression;
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent;
- •Known history of tuberculosis;
- •History of another primary malignancy within 5 years prior to starting treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;
- •Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.
研究组 & 干预措施
Study group B
Patients will receive hypofractionated thoracic radiotherapy with concurrent chemotherapy, combined with tislelizumab during radiotherapy. Patients who achieve complete response, partial response, or stable disease after chemoradiotherapy will receive consolidation therapy with tislelizumab for up to one year.
干预措施: Tislelizumab (Drug)
Study group A
Patients will receive hypofractionated thoracic radiotherapy with concurrent chemotherapy, combined with tislelizumab and surufatinib during radiotherapy. Patients who achieve complete response, partial response, or stable disease after chemoradiotherapy will receive consolidation therapy with tislelizumab and surufatinib for up to one year.
干预措施: Concurrent chemotherapy (Drug)
Study group A
Patients will receive hypofractionated thoracic radiotherapy with concurrent chemotherapy, combined with tislelizumab and surufatinib during radiotherapy. Patients who achieve complete response, partial response, or stable disease after chemoradiotherapy will receive consolidation therapy with tislelizumab and surufatinib for up to one year.
干预措施: Radiotherapy (Radiation)
Study group B
Patients will receive hypofractionated thoracic radiotherapy with concurrent chemotherapy, combined with tislelizumab during radiotherapy. Patients who achieve complete response, partial response, or stable disease after chemoradiotherapy will receive consolidation therapy with tislelizumab for up to one year.
干预措施: Radiotherapy (Radiation)
Study group B
Patients will receive hypofractionated thoracic radiotherapy with concurrent chemotherapy, combined with tislelizumab during radiotherapy. Patients who achieve complete response, partial response, or stable disease after chemoradiotherapy will receive consolidation therapy with tislelizumab for up to one year.
干预措施: Concurrent chemotherapy (Drug)
Study group A
Patients will receive hypofractionated thoracic radiotherapy with concurrent chemotherapy, combined with tislelizumab and surufatinib during radiotherapy. Patients who achieve complete response, partial response, or stable disease after chemoradiotherapy will receive consolidation therapy with tislelizumab and surufatinib for up to one year.
干预措施: Tislelizumab (Drug)
Study group A
Patients will receive hypofractionated thoracic radiotherapy with concurrent chemotherapy, combined with tislelizumab and surufatinib during radiotherapy. Patients who achieve complete response, partial response, or stable disease after chemoradiotherapy will receive consolidation therapy with tislelizumab and surufatinib for up to one year.
干预措施: Surufatinib (Drug)
研究者
Hui Liu
Professor
Sun Yat-sen University