中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600124790
最近更新日期： Date of Last Refreshed on：	2026-05-18 10:47:25
注册时间： Date of Registration：	2026-05-18 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	磷罗拉匹坦帕洛诺司琼联合或不联合地塞米松预防晚期非小细胞肺癌免疫检查点抑制剂联合化疗所致恶心呕吐中的有效性及安全性
Public title：	The efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection with or without Dexamethasone in the prevention of nausea and vomiting induced by immune checkpoint inhibitors combined with chemotherapy in patients with advanced non-small cell lung cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	磷罗拉匹坦帕洛诺司琼联合或不联合地塞米松预防晚期非小细胞肺癌免疫检查点抑制剂联合化疗所致恶心呕吐中的有效性及安全性
Scientific title：	The efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection with or without Dexamethasone in the prevention of nausea and vomiting induced by immune checkpoint inhibitors combined with chemotherapy in patients with advanced non-small cell lung cancer
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：	陈晓霞	研究负责人：	陈晓霞
Applicant：	Xiaoxia Chen	Study leader：	Xiaoxia Chen
申请注册联系人电话： Applicant telephone：	+86 21 6511 5006	研究负责人电话： Study leader's telephone：	+86 21 6511 5006
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：	cheetos_xx@126.com	研究负责人电子邮件： Study leader's E-mail：	cheetos_xx@126.com
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：	上海市杨浦区政民路507号	研究负责人通讯地址：	上海市杨浦区政民路507号
Applicant address：	No. 507 Zhengmin Road, Yangpu District, Shanghai	Study leader's address：	No. 507 Zhengmin Road, Yangpu District, Shanghai
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：	上海市肺科医院
Applicant's institution：	Shanghai Pulmonary Hospital
研究负责人所在单位：	上海市肺科医院
Affiliation of the Leader：	Shanghai Pulmonary Hospital

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	L26-498	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：	上海市肺科医院医学伦理委员会
Name of the ethic committee：	Instituional Review Board Shanghai Pulmonary Hospital Tongji University
伦理委员会批准日期： Date of approved by ethic committee：	2026-04-09 00:00:00
伦理委员会联系人：	桂涛
Contact Name of the ethic committee：	Gui Tao
伦理委员会联系地址：	上海市杨浦区政民路507号
Contact Address of the ethic committee：	No. 507 Zhengmin Road, Yangpu District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 65115006	伦理委员会联系人邮箱： Contact email of the ethic committee：	fkyygcp@163.com

研究实施负责（组长）单位：

上海市肺科医院

Primary sponsor：

Shanghai Pulmonary Hospital

研究实施负责（组长）单位地址：

上海市杨浦区政民路507号

Primary sponsor's address：

No. 507 Zhengmin Road, Yangpu District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市肺科医院	具体地址：	上海市杨浦区政民路507号
Institution hospital：	Shanghai Pulmonary Hospital	Address：	No. 507 Zhengmin Road, Yangpu District, Shanghai

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

self-financing

研究疾病：

化疗所致恶心呕吐

Target disease：

Chemotherapy-Induced Nausea and Vomiting

研究疾病代码：

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：

非随机对照试验

Study design：

Non randomized control

研究目的：

探索磷罗拉匹坦帕洛诺司琼联合或不联合地塞米松预防晚期非小细胞肺癌免疫检查点抑制剂联合化疗所致恶心呕吐中的有效性及安全性

Objectives of Study：

To explore the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection with or without dexamethasone in preventing nausea and vomiting induced by immune checkpoint inhibitors combined with chemotherapy in patients with advanced non-small cell lung cancer

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Signed written informed consent form and voluntary participation in this study;
2. Age 18–75 years at enrollment, regardless of gender;
3. Patients with histopathologically confirmed advanced non-small cell lung cancer;
4. Scheduled to receive ICI (PD-1/PD-L1 inhibitor) combined with a moderately/highly emetogenic platinum-based chemotherapy regimen for the first time, and the chemotherapy regimen does not contain drugs requiring therapeutic-dose corticosteroid premedication;
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0–1;
6. Expected survival duration >= 3 months;
7. Adequate organ function as defined below: a) Hematological function: Absolute neutrophil count >= 1.5×10⁹/L, hemoglobin >= 90 g/dL, platelets >= 100×10⁹/L; b) Hepatic function: Total bilirubin <= 1.5× upper limit of normal (ULN) (patients with known Gilbert syndrome and serum bilirubin <= 3×ULN are eligible); AST and ALT <= 2.5×ULN (≤ 5×ULN in the presence of liver metastases); alkaline phosphatase <= 3×ULN (<= 5×ULN in the presence of liver or bone metastases); albumin >= 30 g/dL; c) Renal function: Serum creatinine <= 1.5×ULN OR estimated glomerular filtration rate (calculated by the Cockcroft-Gault formula) >= 60 mL/min; d) Coagulation function: International normalized ratio (INR) <= 1.5×ULN; activated partial thromboplastin time (APTT) <= 1.5×ULN; e) Electrocardiogram: QTc interval <= 450 ms (male), QTc <= 470 ms (female); f) Echocardiography: Left ventricular ejection fraction (LVEF) >= 50%;
8. Female subjects of childbearing potential, and male subjects whose partners are female of childbearing potential, must use effective contraceptive measures (e.g., intrauterine device, contraceptive pills, or condoms with an annual failure rate of less than 1%) from the time of signing the informed consent form until 6 months after the last dose of study drug. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to enrollment and must not be breastfeeding;
9. Subjects must have good adherence and be willing to comply with follow-up visits.

排除标准：

1.化疗前24小时内出现恶心、呕吐或干呕症状；
2.化疗前48小时内接受过止吐药物治疗（包括NK-1受体拮抗剂、5-HT3受体拮抗剂、糖皮质激素、苯二氮䓬类、阿片类等）；
3.入组前7天内接受过腹部或盆腔放疗，或28天内接受过其他抗肿瘤治疗（如化疗、靶向治疗、免疫治疗、放疗等）；
4.入组前28天内接受过NK-1受体拮抗剂治疗，或14天内接受过5-HT3受体拮抗剂；
5.计划使用需治疗剂量糖皮质激素预处理的化疗药物（如紫杉醇等）；
6.基线期需要使用治疗目的的系统性糖皮质激素（>10mg/天泼尼松等效剂量），或预计研究期间需长期使用该剂量糖皮质激素；
7.对研究药物任何成分过敏；
8.妊娠或哺乳期妇女（女性受试者入组前需确认妊娠试验阴性，研究期间及末次治疗后6个月需采取有效避孕措施）；
9.存在严重器质性疾病且未控制：严重心脏病（如纽约心脏病协会分级III-IV级心力衰竭、未控制的心律失常、近6个月内急性心肌梗死或严重冠脉疾病）、重度肝肾功能不全（肝功能Child-Pugh分级B级及以上、肌酐清除率< 60ml/min）、未控制的糖尿病（空腹血糖≥10mmol/L）、严重电解质紊乱（低钾、低镁未纠正）、严重精神疾病或认知障碍；
10.存在活动性胃肠道梗阻、未控制的脑转移（除非经治疗后症状稳定≥4周且无需糖皮质激素维持治疗）或其他非化疗所致的恶心呕吐病因；
11.存在活动性感染（如严重肺炎、败血症等）或未控制的全身性疾病；
12.患有任何活动性的自身免疫性疾病或自身免疫性疾病病史，包括但不限于：间质性肺炎、肠炎、肝炎、垂体炎、血管炎、肾炎、甲状腺功能亢进、甲状腺功能减退（激素替代治疗后可考虑纳入）；
13.有免疫缺陷病史，包括HIV检测阳性，或患有其他获得性或先天性免疫缺陷疾病，或有器官移植史或异基因骨髓移植史；
14.通过病史或CT检查发现有活动性肺结核感染，或入组前1年内有活动性肺结核感染病史者，或超过1年以前有活动性肺结核感染病史但未经正规治疗者；
15.存在活动性乙肝（HBV DNA≥200 IU/mL或1000 copies/mL或≥其正常值上限），丙型肝炎（丙肝抗体阳性，且HCV RNA高于分析方法检测下限）；
16.入组前30天内参加过其他临床试验（以使用研究药物为准）；
17.研究者认为不适合参与本研究的其他情况（如依从性差、无法完成日记记录、存在影响研究评估的合并症等）；

Exclusion criteria：

1. Presence of nausea, vomiting, or retching within 24 hours before chemotherapy; 2. Received antiemetic therapy within 48 hours before chemotherapy (including NK-1 receptor antagonists, 5-HT3 receptor antagonists, corticosteroids, benzodiazepines, opioids, etc.); 3. Received abdominal or pelvic radiotherapy within 7 days before enrollment, or other antitumor therapy (such as chemotherapy, targeted therapy, immunotherapy, radiotherapy, etc.) within 28 days before enrollment; 4. Received NK-1 receptor antagonist therapy within 28 days before enrollment, or 5-HT3 receptor antagonist therapy within 14 days before enrollment; 5. Planned to use chemotherapy drugs requiring premedication with therapeutic-dose corticosteroids (e.g., paclitaxel); 6. Requiring systemic corticosteroids for therapeutic purposes at baseline (>10 mg/day prednisone equivalent), or expected to require long-term use of such doses during the study; 7. Known hypersensitivity to any component of the study drug; 8. Pregnant or breastfeeding women (female subjects must have a negative pregnancy test before enrollment, and effective contraception must be used during the study and for 6 months after the last treatment); 9. Presence of uncontrolled severe organic diseases, including: severe heart disease (e.g., NYHA class III-IV heart failure, uncontrolled arrhythmia, acute myocardial infarction within the past 6 months, or severe coronary artery disease), severe hepatic or renal insufficiency (Child-Pugh class B or higher liver function, creatinine clearance <60 mL/min), uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L), severe electrolyte disturbances (uncorrected hypokalemia, hypomagnesemia), severe psychiatric disorders or cognitive impairment; 10. Presence of active gastrointestinal obstruction, uncontrolled brain metastases (unless symptoms have been stable for ≥4 weeks after treatment and no corticosteroid maintenance therapy is required), or other causes of nausea and vomiting not related to chemotherapy; 11. Presence of active infection (e.g., severe pneumonia, sepsis, etc.) or uncontrolled systemic disease; 12. Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients on hormone replacement therapy may be considered for inclusion); 13. History of immunodeficiency diseases, including positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation; 14. Active pulmonary tuberculosis infection identified by medical history or CT scan, history of active pulmonary tuberculosis infection within 1 year before enrollment, or history of active pulmonary tuberculosis infection more than 1 year prior but without standard treatment; 15. Active hepatitis B (HBV DNA >= 200 IU/mL or 1000 copies/mL or >= upper limit of normal) or hepatitis C (positive anti-HCV antibody with HCV RNA above the lower limit of detection of the assay); 16. Participation in other clinical trials within 30 days before enrollment (defined as having received the investigational product); 17. Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this study (e.g., poor adherence, inability to complete diary records, comorbidities affecting study assessments, etc.);

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2028-03-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-18 00:00:00 至 To 2027-05-16 00:00:00

干预措施：

Interventions：

组别：	磷罗拉匹坦帕洛诺司琼+地塞米松组	样本量：	66
Group：	Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone	Sample size：	66
干预措施：	注射用磷罗拉匹坦帕洛诺司琼+地塞米松	干预措施代码：
Intervention：	Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone	Intervention code：

组别：	磷罗拉匹坦帕洛诺司琼	样本量：	66
Group：	Fosrolapitant and Palonosetron Hydrochloride for Injection	Sample size：	66
干预措施：	注射用磷罗拉匹坦帕洛诺司琼	干预措施代码：
Intervention：	Fosrolapitant and Palonosetron Hydrochloride for Injection	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市肺科医院	单位级别：	三级甲等
Institution hospital：	Shanghai Pulmonary Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	第1和第2个化疗周期急性期、延迟期、超延迟期的完全缓解率和无补救治疗比例	指标类型：	次要指标
Outcome：	Complete response rate and proportion of patients without rescue medication in the acute phase, delayed phase, and overall phase of the first and second chemotherapy cycles	Type：	Secondary indicator
测量时间点：	整个研究及随访期间	测量方法：	CRF记录
Measure time point of outcome：	During the entire study and follow-up period	Measure method：	CRF

指标中文名：	第一个化疗周期总体期的完全缓解率	指标类型：	主要指标
Outcome：	Complete response rate during the overall period of the first chemotherapy cycle	Type：	Primary indicator
测量时间点：	第一个化疗周期给药120h之后	测量方法：	CRF记录
Measure time point of outcome：	120 hours after administration in the first chemotherapy cycle	Measure method：	CRF

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	75	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）：

由第三方独立统计人员，通过本研究使用的 EDC（电子数据采集）系统内置的中央随机化模块，采用区组随机法生成随机分配序列。研究者与受试者均无法提前获知分配结果。

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

The randomization sequence is generated centrally by an independent statistician using the built-in randomization module of the study’s Electronic Data Capture (EDC) system, using block randomization. Neither investigators nor subjects have prior knowledge of the assignment sequence

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：	开放标签
Blinding：	Open-label study

是否共享原始数据： IPD sharing	否No
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）：	不共享
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Do not share
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：	2026-05-18 10:47:06