ChiCTR2600121692 版本V1.0 版本创建时间2026/04/01 17:13:10 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600121692 

最近更新日期：

Date of Last Refreshed on：

2026-04-01 17:12:54 

注册时间：

Date of Registration：

2026-04-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

瑞拉芙普α联合含铂化疗和阿帕替尼一线治疗晚期NSCLC的临床研究

Public title：

A clinical study of retlirafusp alfa combined with platinum-based chemotherapy and apatinib as first-line treatment for advanced NSCLC

注册题目简写：

English Acronym：

研究课题的正式科学名称：

瑞拉芙普α联合含铂化疗和阿帕替尼一线治疗晚期NSCLC的临床研究

Scientific title：

A clinical study of retlirafusp alfa combined with platinum-based chemotherapy and apatinib as first-line treatment for advanced NSCLC

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

王华 

研究负责人：

王华 

Applicant：

Hua Wang 

Study leader：

Wang Hua 

申请注册联系人电话：

Applicant telephone：

+86 551 62923004

研究负责人电话：

Study leader's telephone：

+86 551 65161115

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

wanghua@anmu.edu.com

研究负责人电子邮件：

Study leader's E-mail：

wanghua@ahmu.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

安徽省合肥市皖水路120号

研究负责人通讯地址：

安徽省合肥市蜀山区绩溪路218号

Applicant address：

No. 120 Wanshui Road, Hefei City, Anhui Province.

Study leader's address：

218 Jixi Road, Hefei City, Anhui Province, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

安徽医科大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Anhui Medical University

研究负责人所在单位：

安徽医科大学第一附属医院

Affiliation of the Leader：

The first affiliated hospital of anhui medical university

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

安医一附院科研伦审-PJ 2026-02-41

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

安徽医科大学第一附属医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of the First Affiliated Hospital of Anhui Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-03-12 00:00:00

伦理委员会联系人：

陈玉

Contact Name of the ethic committee：

Chen Yu

伦理委员会联系地址：

安徽省合肥市蜀山区绩溪路218号

Contact Address of the ethic committee：

218 Jixi Road, Hefei City, Anhui Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 551 62923004

伦理委员会联系人邮箱：

Contact email of the ethic committee：

ayfykyll@163.com

研究实施负责（组长）单位：

安徽医科大学第一附属医院

Primary sponsor：

The first affiliated hospital of anhui medical university

研究实施负责（组长）单位地址：

安徽省合肥市蜀山区绩溪路218号

Primary sponsor's address：

218 Jixi Road, Hefei City, Anhui Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

安徽省

市(区县)：

Country：

China

Province：

Anhui

City：

单位(医院)：

安徽医科大学第一附属医院

具体地址：

安徽省合肥市蜀山区绩溪路218号

Institution
hospital：

The first affiliated hospital of anhui medical university

Address：

218 Jixi Road, Hefei City, Anhui Province, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

self-raised funds

Target disease：

non-small cell lung cancer

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

单臂 

Study design：

Single arm 

研究目的：

探索瑞拉芙普α+阿帕替尼+含铂化疗一线治疗晚期NSCLC的有效性和安全性  

Objectives of Study：

To explore the efficacy and safety of Rilapladib α + Apatinib + platinum-based chemotherapy as the first-line treatment for advanced NSCLC.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄≥18 周岁，性别不限； 2.病理组织学或细胞学证实的非小细胞肺癌； 3.TNM分期IIIb-IV期（根据国际抗癌联盟/美国癌症联合委员会癌症分期系统第九版）； 4.无EGFR敏感性突变且无ALK融合、ROS1基因重排； 5.既往未接受过针对晚期/转移性 NSCLC 的全身系统性治疗。允许系统治疗和/或放疗作为新辅助/辅助治疗的一部分使用，只要治疗在诊断出晚期或转移性疾病前已经结束至少 12 个月； 6.建议提供肿瘤组织样本[可为未经放疗的存档或新鲜获取的组织样本，不接受针吸细胞学样本（无完整组织结构，仅有悬液或细胞涂片）、刷检样本、胸腔积液细胞沉淀以及支气管肺泡灌洗液样本）]用于中心实验室检测 PD-L1 的表达。 7.有至少1处可测量病灶，根据RECIST 1.1 标准； 8.体力状况评分（ECOG PS评分）：0-1分； 9.预计生存期≥ 3个月； 10.主要脏器功能良好，即入组前14天内相关检查指标满足以下要求：红蛋白 ≥ 90 g/L（14天内未输血）；中性粒细胞计数> 1.5×10^9/L；血小板计数≥ 100×10^9/L；总胆红素 ≤ 1.5×ULN（正常值上限）；血谷丙转氨酶（ALT）或血谷草转氨酶（AST） ≤ 2.5×ULN；如有肝转移，则ALT或AST ≤ 5×ULN；内生肌酐清除率 ≥ 60 mL/min（Cockcroft-Gault公式）； 11.育龄妇女必须在首次用药前3天内进行血清妊娠检测，且结果为阴性。育龄妇女受试者和伴侣为育龄妇女的男性受试者必须同意在研究期间和末次给予研究药物后180天内采用高效方法避孕。 12.理解研究步骤和内容，并自愿签署书面知情同意书；

Inclusion criteria

1.Age >= 18 years old, gender not limited; 2. Pathologically confirmed non-small cell lung cancer by histology or cytology; 3. TNM stage IIIb-IV (according to the 9th edition of the International Union Against Cancer/American Joint Committee on Cancer Cancer Staging System); 4.No EGFR sensitive mutation and no ALK fusion or ROS1 gene rearrangement; 5.No previous systemic treatment for advanced/metastatic NSCLC. Systemic therapy and/or radiotherapy as part of neoadjuvant/adjuvant treatment is allowed, provided that the treatment was completed at least 12 months before the diagnosis of advanced or metastatic disease; 6.It is recommended to provide tumor tissue samples (archived or freshly obtained tissue samples without radiotherapy, excluding needle aspiration cytology samples (without complete tissue structure, only suspension or cell smear), brush samples, pleural effusion cell sediment, and bronchoalveolar lavage fluid samples) for central laboratory testing of PD-L1 expression. 7. At least one measurable lesion according to RECIST 1.1 criteria; 8.Performance status score (ECOG PS score): 0-1; 9.Expected survival >= 3 months; 10. Good major organ function, that is, the relevant examination indicators within 14 days before enrollment meet the following requirements: hemoglobin >= 90 g/L (no blood transfusion within 14 days); neutrophil count > 1.5×10^9/L; platelet count >= 100×10^9/L; total bilirubin <= 1.5×ULN (upper limit of normal); ALT or AST <= 2.5×ULN; if there is liver metastasis, ALT or AST <= 5×ULN; estimated glomerular filtration rate >= 60 mL/min (Cockcroft-Gault formula); 11.Women of childbearing age must undergo serum pregnancy testing within 3 days before the first dose and the result must be negative. Women of childbearing age and male subjects whose partners are of childbearing age must agree to use highly effective contraceptive methods during the study and for 180 days after the last administration of the study drug; 12. Understand the study procedures and contents, and voluntarily sign the written informed consent form.

排除标准：

1. 诊断为其他病理组织学类型的非小细胞肺癌受试者，包括鳞腺混合癌受试者、含小细胞肺癌成份的NSCLC受试者。 2.已知EGFR敏感突变、ALK融合、ROS1重排的受试者。 3.排除可以手术切除或根治性放射治疗的受试者。 4.针对IIIb-IV 期疾病接受过既往化疗或其他全身治疗的受试者。 5.肿瘤病灶侵犯大血管且具有明显出血风险者（如中央型肺鳞癌）。 6.存在活动性中枢神经系统（CNS）转移的受试者。如果受试者的CNS转移能够充分治疗，如临床稳定（MRI检测）已维持至少4周，并且受试者的神经系统等临床症状能够在首次用药前至少2周恢复到基线水平（与CNS治疗有关的残留体征或症状除外），则可以参加研究。此外，受试者如果使用皮质类固醇类激素治疗相关临床症状，接受剂量稳定或逐渐降低的≤10 mg/天的泼尼松（或等价物）至少2周方可参加研究，否则不能入组。 7.患有活跃的、已知的或怀疑患有自身免疫性疾病的受试者。允许入组处于稳定状态、不需要全身免疫抑制剂治疗的受试者，如患有 I 型糖尿病、只需接受激素替代治疗的甲状腺功能减退症、无需进行全身治疗的皮肤疾病（例如，白癜风、银屑病或脱发）。 8.患有先天或后天免疫功能缺陷，如人类免疫缺陷病毒（HIV）感染者； 9.诊断为免疫缺陷或研究入组前7天内正在接受与肿瘤治疗非直接相关的全身性糖皮质激素治疗或任何其他形式的免疫抑制疗法；允许使用生理剂量的糖皮质激素（≤10 mg/天的强的松或等效药物）； 10.患有以下控制不佳的传染病：活动性乙型病毒性肝炎（HBsAg阳性且HBV DNA≥500 IU/ml或1000 copies/ml）或丙型病毒性肝炎（丙肝抗体阳性且HCV-RNA 高于分析方法的检测下限）；活动性结核或目前正在接受抗结核治疗； 11.既往或现在有特发性肺纤维化、间质性肺炎、尘肺、放射性肺炎、组织性肺炎(如支气管炎、闭塞性血管炎)、药物性肺炎、CT检查中的活动性肺炎或肺功能严重受损的客观证据； 12.未控制的胸腔积液、心包积液，或腹水需要反复引流（一月一次或更频繁） 允许患者留置导管。 13.高血压控制不佳（收缩压＞150 mmHg 和/或舒张压＞100 mmHg） 允许接受抗高血压治疗达到上述参数。 14.启动研究治疗前3 个月内发生重大心血管疾病（如纽约心脏病学会心脏疾病（评级为II 级或更高的心脏病）、心肌梗死或脑血管事件）、不稳定性心律失常或不稳定性心绞痛。已知患有冠状动脉疾病、心律失常、充血性心力衰竭但未达到上述标准的患者，必须接受主治医生认为最佳的稳定治疗方案治疗，必要时可咨询心脏病专家。 15.心脏功能和疾病符合下述情况之一，研究者认为具有临床意义，明显异常而不适合入组本研究的心律失常，包括但不限于完全性左束支传导异常，II度房室传导阻滞；12导联心电图（ECG）测量，QTc间期男性≥450ms、女性≥470ms ；美国纽约心脏学会（NYHA）分级≥3级心功能不全或心脏彩超检查：左室射血分数(LVEF)＜50% 。 16.存在出血倾向或凝血功能障碍的证据（未使用治疗性抗凝剂的情况下）、正在或近期（开始研究治疗前10 天内）服用阿司匹林（＞325 mg/天）、氯吡格雷（＞75mg/天）或接受双嘧达莫、噻氯匹定或西洛他唑治疗。 17.在入组前的6 个月内，存在脑卒中或短暂性脑缺血发作史者。 18.入组前4周内发生过严重感染（CTCAE＞2级），如需治疗的感染并发症、菌血症、重症肺炎等；首次使用药物前2周内存在感染的症状和体征需要口服或静脉使用抗生素治疗（不包括预防性使用抗生素的情况）由于感染引起的需要全身性使用抗生素的受试者； 19.尿常规提示尿蛋白≥++且证实24小时尿蛋白定量>1.0 g； 20.在入组前的6 个月内，存在腹部或气管食管瘘或者胃肠穿孔者。 21.存在严重胃肠功能异常，可能影响阿帕替尼的摄入、转运或吸收者（如无法吞咽、无法控制的呕吐、大面积胃肠道切除史、慢性腹泻、需长期服用PPI类抑酸药物的胃部疾病、克罗恩病、溃疡性结肠炎、肠梗阻等）。 22.入组前≤5年并发其他恶性肿瘤，可以充分治疗的宫颈原位癌、基底细胞或鳞状上皮细胞皮肤癌、根治术后的局部前列腺癌、根治术后的导管原位癌除外； 23.入组前 4 周内或计划在本研究期间接受大手术（不包括诊断性的外科手术）； 24.入组前 4 周内接种过或计划在研究期间接种活疫苗； 25.酒精依赖者或近 1年内有吸毒或药物滥用史； 26.已知有明确的神经或精神障碍，如癫痫、痴呆症，或存在外周神经系统障碍者； 27.已知有异体器官移植史或异体造血干细胞移植史； 28.怀孕或者哺乳期妇女；有生育能力的受试者不愿或无法采取有效的避孕措施者； 29.已知对研究药物或辅料过敏； 30.入组前 4周内曾接受其它任何试验药物治疗或参加过另一项干预性临床研究； 31.根据研究者的判断，患有可能混淆研究结果、干扰受试者参与研究程序或不符合受试者参加研究最佳利益的任何疾病、治疗或实验室异常的受试者。

Exclusion criteria：

1.Subjects diagnosed with other pathological types of non-small cell lung cancer, including those with squamous adenocarcinoma and those with NSCLC containing small cell lung cancer components; 2. Subjects with known EGFR sensitive mutations, ALK fusion, and ROS1 rearrangement; 3. Subjects who can undergo surgical resection or radical radiotherapy; 4. Subjects who have received previous chemotherapy or other systemic treatment for stage IIIb-IV disease; 5. Subjects with tumor lesions invading major blood vessels and having a significant risk of bleeding (such as central type lung squamous carcinoma); 6. Subjects with active central nervous system (CNS) metastases. If the CNS metastases of the subjects can be adequately treated, such as when the clinical stability (detected by MRI) has been maintained for at least 4 weeks, and the neurological symptoms of the subjects can recover to the baseline level (excluding residual signs or symptoms related to CNS treatment) at least 2 weeks before the first administration of the drug, they can participate in the study. Additionally, if the subjects use corticosteroid hormones to treat related clinical symptom; 7. Subjects with active, known or suspected autoimmune diseases. Subjects in a stable state and not requiring systemic immunosuppressive therapy are allowed to be enrolled, such as those with type I diabetes, hypothyroidism that only requires hormone replacement therapy, or skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis or alopecia); 8. Those with congenital or acquired immune system deficiencies, such as individuals infected with the Human Immunodeficiency Virus (HIV); 9. Diagnosis of immunodeficiency or use of systemic glucocorticoid therapy (not directly related to tumor treatment) or any other form of immunosuppressive therapy within 7 days prior to enrollment in the study; Administration of physiological doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent drugs) is permitted; 10. Have the following poorly controlled infectious diseases: active hepatitis B (with positive HBsAg and HBV DNA >= 500 IU/ml or 1000 copies/ml) or hepatitis C (with positive hepatitis C antibody and HCV-RNA above the detection limit of the analytical method); active tuberculosis or currently undergoing anti-tuberculosis treatment; 11. There is a previous or current history of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pneumonia, organizing pneumonia (such as bronchitis, obliterative arteritis), drug-induced pneumonia, active pneumonia detected by CT examination, or objective evidence of severe impairment of lung function; 12. Uncontrolled pleural effusion, pericardial effusion, or ascites may require repeated drainage (once a month or more frequently). Patients may be allowed to have a catheter inserted. 13. Poor control of hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) allows for the administration of antihypertensive treatment to achieve the above parameters; 14. Before initiating the treatment, patients must have experienced major cardiovascular diseases (such as New York Heart Association heart diseases (rated as grade II or higher), myocardial infarction, or cerebrovascular events), unstable arrhythmias or unstable angina pectoris within the previous 3 months. Patients known to have coronary artery disease, arrhythmias, or congestive heart failure but not meeting the above criteria must receive the treatment plan deemed optimal by their attending physicians. In case of necessity, they can consult a cardiologist; 15. Cardiac function and diseases meeting any of the following conditions are considered clinically significant by the researchers and are considered abnormal and unsuitable for inclusion in this study. Arrhythmias include, but are not limited to, complete left bundle branch block, second-degree atrioventricular block; 12-lead electrocardiogram (ECG) measurement, QTc interval for males ≥ 450 ms and for females >= 470 ms; New York Heart Association (NYHA) classification >= 3 grade cardiac insufficiency or echocardiography: left ventricular ejection fraction (LVEF) < 50%. 16. There is evidence of bleeding tendency or coagulation dysfunction (without the use of therapeutic anticoagulants), currently taking or having taken aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or receiving dipyridamole, ticlopidine or cilostazol treatment within the past 10 days prior to the start of the study treatment; 17. Those who had a history of stroke or transient ischemic attack within 6 months prior to enrollment; 18. Subjects who had experienced severe infections within 4 weeks prior to enrollment (CTCAE > grade 2), such as infectious complications requiring treatment, bacteremia, severe pneumonia, etc.; subjects who had symptoms and signs of infection within 2 weeks before the first use of the drug and required oral or intravenous antibiotic treatment (excluding cases of prophylactic use of antibiotics); subjects who required systemic use of antibiotics due to infections; 19. The urine routine test indicated that the urine protein level was >=++ and the 24-hour urine protein quantification was greater than 1.0 g; 20. Those who had abdominal or tracheoesophageal fistulas or gastrointestinal perforations within 6 months prior to enrollment. 21. There are cases of severe gastrointestinal dysfunction that may affect the intake, transport or absorption of apatinib (such as inability to swallow, uncontrollable vomiting, extensive history of gastrointestinal resection, chronic diarrhea, gastric diseases requiring long-term use of PPI acid-suppressing drugs, Crohn's disease, ulcerative colitis, intestinal obstruction, etc.); 22. Participants who had concurrent other malignant tumors within the previous 5 years, except for cervical carcinoma in situ that can be fully treated, basal cell or squamous epithelial cell skin cancer after radical surgery, and local prostate cancer after radical surgery, are excluded; 23. Participants who had undergone major surgery (excluding diagnostic surgeries) within the previous 4 weeks before enrollment or who planned to undergo such surgery during the course of this study; 24. Participants who received or were scheduled to receive live vaccines within 4 weeks prior to enrollment; 25. Alcohol-dependent individuals or those who have a history of drug use or substance abuse within the past 1 year; 26. Individuals with clearly identified neurological or mental disorders, such as epilepsy, dementia, or peripheral nervous system disorders, are excluded. 27.Those who have a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 28. Pregnant or lactating women; subjects with reproductive capacity who are unwilling or unable to take effective contraceptive measures; 29.Known to be allergic to the studied drug or excipients; 30.Within the previous 4 weeks prior to enrollment, the participant had received any other investigational drug treatment or had participated in another interventional clinical study; 31. According to the researchers' judgment, subjects who have any diseases, treatments, or laboratory abnormalities that may confuse the research results, interfere with the participants' participation in the research process, or are not in the best interests of the participants' participation in the research.

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2029-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-04-01 00:00:00 至 To 2027-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

35

Group：

Experimental group

Sample size：

干预措施：

瑞拉芙普α+阿帕替尼+含铂化疗

干预措施代码：

Intervention：

Retlirafusp alfa + Apatinib + Platinum-based chemotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽省 

市(区县)：

  

Country：

China 

Province：

Anhui 

City：

 

单位(医院)：

安徽医科大学第一附属医院 

单位级别：

三级甲等 

Institution
hospital：

The first affiliated hospital of anhui medical university

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 安徽省 

市(区县)：

  

Country：

China 

Province：

Anhui 

City：

 

单位(医院)：

安徽省胸科医院 

单位级别：

三级甲等 

Institution
hospital：

Anhui Provincial Chest Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

安全性

指标类型：

次要指标

Outcome：

Safety

Type：

Secondary indicator

测量时间点：

每 3 周一次

测量方法：

实验室和临床检查

Measure time point of outcome：

Every 3 weeks

Measure method：

Laboratory and clinical examinations

指标中文名：

无进展生存期

指标类型：

主要指标

Outcome：

Progression free survival

Type：

Primary indicator

测量时间点：

每 6 周一次

测量方法：

CT/MRI

Measure time point of outcome：

Every 6 weeks

Measure method：

CT/MRI

指标中文名：

客观缓解率

指标类型：

次要指标

Outcome：

Objective Response Rate

Type：

Secondary indicator

测量时间点：

每 6 周一次

测量方法：

CT/MRI

Measure time point of outcome：

Every 6 weeks

Measure method：

CT/MRI

指标中文名：

疾病控制率

指标类型：

次要指标

Outcome：

Disease Control Rate

Type：

Secondary indicator

测量时间点：

每 6 周一次

测量方法：

CT/MRI

Measure time point of outcome：

Every 6 weeks

Measure method：

CT/MRI

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

Overall Survival

Type：

Secondary indicator

测量时间点：

每 3 月一次

测量方法：

电话随访

Measure time point of outcome：

Every 3 months

Measure method：

follow-up by telephone

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

文章发表后，请邮件咨询

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

After the article is published, please contact us by email.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

CRF

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-01 17:12:54