NCT07103395招募中2 期
A Phase II Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade (PD-1/CTLA-4) in Patients With Locally Advanced Non-Small Cell Lung Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年1月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This study will enroll patients with locally advanced non-small cell lung cancer (NSCLC). Patients will receive neoadjuvant chemotherapy combined with dual immune checkpoint blockade (PD-1/CTLA-4), bevacizumab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with dual immune checkpoint blockade (PD-1/CTLA-4), surufatinib and thymosin alpha 1. The study aims to evaluate the efficacy and safety of this treatment regimen.
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
- 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 locally advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC);
- •EGFR, ALK, and ROS1 wild-type;
- •No prior chemotherapy, radiotherapy, surgery, targeted therapy, or 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
- •Exclusion criteria for enrolment for neoadjuvant therapy. Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •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;
- •Prior use of anti-PD-1, anti-PD-L1, or anti-CTLA4 antibodies;
- •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.
- •Exclusion criteria for concurrent chemoradiation following neoadjuvant therapy. Patients should not enter the concurrent chemoradiation phase if any of the following exclusion criteria are fulfilled:
- •Patients who develop distant metastasis;
- •Patients who develop locoregional disease progression and the irradiation dose of normal tissue will exceed the limit.
- •World Health Organization (WHO) Performance Status of 2-4;
- •Inadequate organ and marrow function as defined below:
- •Forced expiratory volume in 1 second (FEV1) <800ml
- •Absolute neutrophil count <1.5 x 109/L (1500 per mm3)
- •Platelets <100 x 109/L (100,000 per mm3)
- •Haemoglobin<9.0 g/dL (5.59 mmol/L)
- •Serum creatinine CL <50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976)
- •Serum bilirubin >1.5 x upper limit of normal (ULN).
- •Aspartate Transaminase(AST) and Alanine Transaminase(ALT) >2.5 x ULN.
- •Further exclusion criteria for consolidation therapy. Patients should not enter the consolidation therapy if any of the following exclusion criteria are fulfilled:
- •Patients who have progressed whilst definitive platinum based, concurrent chemoradiation therapy;
- •Current or prior use of immunosuppressive medication within 28 days before the first dose of Iparomlimab and tuvonralimab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.
- •Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy will be excluded from randomization;
- •Patients with Grade ≥2 pneumonitis from prior chemoradiation therapy will be excluded from randomization;
- •Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE>Grade 1.
研究组 & 干预措施
The study group
Experimental
Patients will receive neoadjuvant chemotherapy combined with iparomlimab and tuvonralimab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with iparomlimab and tuvonralimab and thymosin alpha 1.
干预措施: Neoadjuvant therapy (Drug)
The study group
Experimental
Patients will receive neoadjuvant chemotherapy combined with iparomlimab and tuvonralimab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with iparomlimab and tuvonralimab and thymosin alpha 1.
干预措施: Radiotherapy (Radiation)
The study group
Experimental
Patients will receive neoadjuvant chemotherapy combined with iparomlimab and tuvonralimab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with iparomlimab and tuvonralimab and thymosin alpha 1.
干预措施: Consolidative therapy (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2-year
PFS measures the time from the start date of treatment to disease progression, death from any cause or last follow up if alive.
次要结局
- Overall survival(2-year)
- Objective response rate(2 month after treatment)
- Treatment-related toxicity(through study completion, an average of 18 months)
研究者
Hui Liu
Professor
Sun Yat-sen University
研究点 (1)
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