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
NCT ID: NCT05353257
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
511 participants
INTERVENTIONAL
2022-05-17
2028-05-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
HLX10
Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
300mg Q3W
carboplatin/cisplatin-etoposide
Etoposide: 100 mg/m2, IV, on Days 1, 2, and 3 of each cycle. Carboplatin: AUC = 5, IV, on Day 1 of each cycle up to a dose of 750 mg. investigator's choice.
Cisplatin: 75mg/m2, IV, on Days 1 of each cycle. investigator's choice.
Thoracic radiotherapy
Standard Thoracic Radiotherapy
Prophylactic Cranial Irradiation (PCI)
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
placebo + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
carboplatin/cisplatin-etoposide
Etoposide: 100 mg/m2, IV, on Days 1, 2, and 3 of each cycle. Carboplatin: AUC = 5, IV, on Day 1 of each cycle up to a dose of 750 mg. investigator's choice.
Cisplatin: 75mg/m2, IV, on Days 1 of each cycle. investigator's choice.
Thoracic radiotherapy
Standard Thoracic Radiotherapy
Placebo
Placebo Q3W
Prophylactic Cranial Irradiation (PCI)
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
Interventions
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HLX10
Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
300mg Q3W
carboplatin/cisplatin-etoposide
Etoposide: 100 mg/m2, IV, on Days 1, 2, and 3 of each cycle. Carboplatin: AUC = 5, IV, on Day 1 of each cycle up to a dose of 750 mg. investigator's choice.
Cisplatin: 75mg/m2, IV, on Days 1 of each cycle. investigator's choice.
Thoracic radiotherapy
Standard Thoracic Radiotherapy
Placebo
Placebo Q3W
Prophylactic Cranial Irradiation (PCI)
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically diagnosed with SCLC.
3. Diagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.
4. Major organs are functioning well.
Exclusion Criteria
2. Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
3. Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
4. Patients with other active malignancies within 5 years or at the same time.
5. Subjects with known history of severe allergy to any monoclonal antibody.
6. Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
7. In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.
18 Years
ALL
No
Sponsors
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Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Jinming Yu, MD
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital & Institute-department
Ying Cheng
Role: PRINCIPAL_INVESTIGATOR
Jilin Provincial Tumor Hospital
Locations
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OPN-Glendale
Arcadia, California, United States
OPN-Los Alamitos
Los Alamitos, California, United States
Southern California Permanente Group
Los Angeles, California, United States
Emad Ibrahim, MD, Inc
Redlands, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
Lutheran Medical Center - Cancer Centers of Colorado
Golden, Colorado, United States
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Napa Research
Pompano Beach, Florida, United States
Kansas University Mediacal Center
Fairway, Kansas, United States
Pontchartrain Cancer Center
Covington, Louisiana, United States
Tulane University
New Orleans, Louisiana, United States
Health Partners
Bloomington, Minnesota, United States
Renown Health
Reno, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York City Health+HospitalsCorporation Elmhurst Hospital Center
Elmhurst, New York, United States
Northwell Health
Queens, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic Mercy Hospital
Canton, Ohio, United States
Gabrail Cancer Center
Canton, Ohio, United States
Tricounty Hematology and Oncology Associates
Massillon, Ohio, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Millennium Research & Clinical Development
Houston, Texas, United States
Pro Research Tools, INC DBA Lumi Research
Kingwood, Texas, United States
The University of Texas - Hope Cancer Center
Tyler, Texas, United States
Innova Schar Cancer Insitute
Fairfax, Virginia, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Klinikum Klagenfurt am Worthersee
Klagenfurt, , Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, , Austria
Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie
Vienna, , Austria
Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology
Vienna, , Austria
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Chest Hospital
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical
Chongqing, Chongqing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Gungzhouyikedaxuefushuzhongliuyiyuan
Guangzhou, Guangzhou, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
Tangshan People's Hospital
Tangshan, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hong Kong United Oncology Centre
Hong Kong, Hong Kong, China
Queen Elizabeth Hospital
Hong Kong, Hong Kong, China
Queen Mary Hospital
Hong Kong, Hong Kong, China
TaiHe Hospital Affiliated Hospital of Hubei University of Medicine
Shiyan, Hubei, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Zhongnan hospital of wuhan university
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The First People's Hospital Of Changde City
Changde, Hunan, China
The Second Xiangya Hospita
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Northern Jiangsu people's Hospital
Yangzhou, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Shenyang The Tenth People's Hospital
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
Linyi Tumor Hospital
Linyi, Shandong, China
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Wenzhou University Hospital
Wenzhou, Shanghai Municipality, China
Baoji Central Hospital
Baoji, Shanxi, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second People's Hospital Of Yibin
Sichuan, Yibin, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Yuhang Branch of the First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The 1st Affiliated Hospital of WMU
Wenzhou, Zhejiang, China
University Hospital Brno (Clinic For Lung Diseases and Tuberculosis)
Brno, , Czechia
University Hospital Brno
Brno, , Czechia
University Hospital Olomouc (Oncology Clinic)
Olomouc, , Czechia
University Hospital Ostrava (oncology department)
Ostrava-Poruba, , Czechia
University Hospital Ostrava
Ostrava-Poruba, , Czechia
Nemocnice AGEL Ostrava-Vítkovice
Ostrava-Vitkovice, , Czechia
Nemocnice AGEL Ostrava-Vítkovice
Ostrava-Vítkovice, , Czechia
General University hospital in Prague (Oncology department)
Prague, , Czechia
University Hospital Motol
Prague, , Czechia
University Hospital Motol (Pneumology Clinic 2.LF UK and FN Motol)
Prague, , Czechia
Kliniken der Stadt Cologne GmbH
Cologne, , Germany
University hospital Schleswig-Holstein
Travemünde, , Germany
"Sotiria" Thoracic Diseases General Hospital of Athens
Athens, , Greece
General Hospital of Athens "Alexandra"
Athens, , Greece
Fejer County Szent Gyorgy University Teaching Hospital
Székesfehérvár, , Hungary
Pulmonary Institute of Torokbalint
Törökbálint, , Hungary
Riga East University Hospital, Latvian Oncology Center
Riga, , Latvia
Clinic of Oncology, Pauls Stradins Clinical university hospital
Riga, , Latvia
Hospital St. Jansdal
Harderwijk, , Netherlands
Isala Hospital
Zwolle, , Netherlands
MedPoloniaSp. z o.o.
Poznan, , Poland
Lung and Chest Cancer Clinic, National Institute of Oncology
Warsaw, , Poland
Hospital Universitario de Badajoz
Badajoz, , Spain
Hospital German Trias i Pujol/ ICO Badalona
Badalona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Gregorio Marañon
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Quironsalud Sagrado Corazón
Seville, , Spain
Hospital Marques de Valdecilla
Valdecilla, , Spain
University Hospital La Fe
Valencia, , Spain
Countries
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Other Identifiers
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HLX10-020-SCLC302
Identifier Type: -
Identifier Source: org_study_id
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