Lung Cancer Clinical Trial

A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

Summary

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10 + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.

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Full Description

Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.

Arm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female, aged ≥18 years when signing the ICF.
Histologically diagnosed with SCLC.
Diagnosed with LS-SCLC (stage â… -â…¢ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.
Major organs are functioning well.

Exclusion Criteria:

Histologically or cytologically confirmed mixed SCLC.
Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
Patients with other active malignancies within 5 years or at the same time.
Subjects with known history of severe allergy to any monoclonal antibody.
Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

482

Study ID:

NCT05353257

Recruitment Status:

Recruiting

Sponsor:

Shanghai Henlius Biotech

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There are 65 Locations for this study

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Providence Medical Group
Anaheim California, 92805, United States More Info
Study Coordinator
Contact
Research Site
Orange California, 32763, United States More Info
Study Coordinator
Contact
Kaiser Permanente Research
Pasadena California, 91101, United States More Info
Study Coordinator
Contact
Emad Ibrahim, MD, INC-Redlands Community
Redlands California, 92373, United States More Info
Study Coordinator
Contact
Research Site
Santa Rosa California, 95403, United States More Info
Study Coordinator
Contact
Renown Health
Reno Nevada, 89502, United States More Info
Study Coordinator
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Tricounty Hematology and Oncology Associates
Massillon Ohio, 44646, United States More Info
Study Coordinator
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Ascend Pharma Holdings
Houston Texas, 77015, United States More Info
Study Coordinator
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The University of Texas at Tyler
Tyler Texas, 75701, United States More Info
Study Coordinator
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Northwest Medical Specialties
Tacoma Washington, 98405, United States More Info
Study Coordinator
Contact
Klinikum Klagenfurt am Wörthersee
Klagenfurt am Wörthersee , 9020, Austria More Info
Markus Rauter
Contact
Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie
Wien , 1210, Austria More Info
Maximilian Hochmair
Contact
The First Affiliated Hospital of Bengbu Medical College
Bengbu Anhui, 23309, China
Anhui Chest Hospital
Hefei Anhui, 23003, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing Beijing, 10002, China
Beijing Cancer Hospital
Beijing Beijing, 10014, China
The First Affiliated Hospital of Chongqing Medical
Chongqing Chongqing, 40001, China
Chongqing University Cancer Hospital
Chongqing Chongqing, 40003, China
Fujian Cancer Hospital
Fuzhou Fujian, 35001, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou Guangdong, 51000, China
Sun Yat-Sen University Cancer Center
Guangzhou Guangdong, 51003, China
Peking University Shenzhen Hospital
Shenzhen Guangdong, 51803, China
The Second Affiliated Hospital of Guilin Medical University
Guilin Guangxi, 54110, China
Guangxi Medical University Cancer Hospital
Nanning Guangxi, 53002, China
Gungzhouyikedaxuefushuzhongliuyiyuan
Guangzhou Guangzhou, 51009, China
Affiliated Hospital of Hebei University
Baoding Hebei, 07100, China
Cangzhou People's Hospital
Cangzhou Hebei, 06101, China
Tangshan People's Hospital
Tangshan Hebei, 06300, China
Harbin Medical University Cancer Hospital
Harbin Heilongjiang, 15000, China
Jiamusi Cancer Hospital
Jiamusi Heilongjiang, 15400, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang Henan, 47100, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang Henan, 45310, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou Henan, 45005, China
Hong Kong United Oncology Centre
Hong kong Hong Kong, 99907, China More Info
Jacky Li
Contact
Queen Elizabeth Hospital
Hong Kong Hong Kong, 99907, China More Info
Lee Tin Yan
Contact
Queen Mary Hospital
Hong Kong Hong Kong, 99907, China More Info
Dennis Leung
Contact
TaiHe Hospital Affiliated Hospital of Hubei University of Medicine
Shiyan Hubei, 44200, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan Hubei, 43003, China
Zhongnan hospital of wuhan university
Wuhan Hubei, 43007, China
Hubei Cancer Hospital
Wuhan Hubei, 43007, China
The First People's Hospital Of Changde City
Changde Hunan, 41500, China
The Second Xiangya Hospita
Changsha Hunan, 41000, China
Hunan Cancer Hospital
Changsha Hunan, 41001, China
Xiangya Hospital Central South University
Changsha Hunan, 41001, China
Xuzhou Central Hospital
Xuzhou Jiangsu, 22100, China
Northern Jiangsu people's Hospital
Yangzhou Jiangsu, 21000, China
First Affiliated Hospital of Gannan Medical University
Ganzhou Jiangxi, 34100, China
Ganzhou Cancer Hospital
Ganzhou Jiangxi, 34100, China
The First Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China
Jilin Cancer Hospital
Changchun Jilin, 13000, China
Liaoning Cancer Hospital & Institute
Shenyang Liao Ning, 11004, China
Shenyang The Tenth People's Hospital
Shenyang Liao Ning, 11004, China
Qilu Hospital of Shandong University
Jinan Shandong, 25001, China
Shandong Cancer Hospital
Jinan Shandong, 25011, China
Linyi Tumor Hospital
Linyi Shandong, 27600, China
Affiliated Hospital of Qingdao University
Qingdao Shandong, 26603, China
Shanghai Chest Hospital
Shanghai Shanghai, 20003, China
Fudan University Shanghai Cancer Center
Shanghai Shanghai, 20003, China
Zhongshan Hospital of Fudan University
Shanghai Shanghai, 20003, China
Wenzhou University Hospital
Wenzhou Shanghai, 20003, China
Baoji Central Hospital
Baoji Shanxi, 72100, China
Shanxi Provincial Cancer Hospital
TaiYuan Shanxi, 03001, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an Shanxi, 71006, China
West China Hospital of Sichuan University
Chengdu Sichuan, 61004, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin Tianjin, 30005, China
Tianjin Medical University General Hospital
Tianjin Tianjin, 30005, China
The Second People's Hospital Of Yibin
Sichuan Yibin, 64400, China
Yunnan Cancer Hospital
Kunming Yunnan, 65011, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou Zhejiang, 31000, China
Yuhang Branch of the First Affiliated Hospital of Zhejiang University
Hangzhou Zhejiang, 31000, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31000, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou Zhejiang, 31000, China
Taizhou Hospital of Zhejiang Province
Taizhou Zhejiang, 31700, China
The 1st Affiliated Hospital of WMU
Wenzhou Zhejiang, 32500, China
University Hospital Brno
Brno , 625 0, Czechia More Info
Kristian Brat
Contact
University Hospital Ostrava
Ostrava-Poruba , , Czechia More Info
Kamila Resova
Contact
Nemocnice AGEL Ostrava-Vítkovice
Ostrava-Vítkovice , 703 0, Czechia More Info
Jaromir Roubec
Contact
University Hospital Motol
Prague , 150 0, Czechia More Info
Leona Koubkova
Contact

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

482

Study ID:

NCT05353257

Recruitment Status:

Recruiting

Sponsor:


Shanghai Henlius Biotech

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