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
- Conditions
- Limited-Stage Small Cell Lung Cancer
- Interventions
- Drug: carboplatin/cisplatin-etoposideRadiation: Thoracic radiotherapyDrug: PlaceboRadiation: Prophylactic Cranial Irradiation (PCI)
- Registration Number
- NCT05353257
- Lead Sponsor
- Shanghai Henlius Biotech
- Brief Summary
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.
- Detailed 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 511
- Male or female, aged ≥18 years when signing the ICF.
- Histologically diagnosed with SCLC.
- 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.
- Major organs are functioning well.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy Thoracic 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. Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy carboplatin/cisplatin-etoposide 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. placebo + carboplatin/cisplatin-etoposide + radiotherapy carboplatin/cisplatin-etoposide 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. Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy HLX10 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. Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy Prophylactic Cranial Irradiation (PCI) 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. placebo + carboplatin/cisplatin-etoposide + radiotherapy Thoracic 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. placebo + carboplatin/cisplatin-etoposide + radiotherapy Placebo 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. placebo + carboplatin/cisplatin-etoposide + radiotherapy Prophylactic Cranial Irradiation (PCI) 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.
- Primary Outcome Measures
Name Time Method Overall survival(OS up to 36 months the time from randomization to death due to any cause
- Secondary Outcome Measures
Name Time Method Progression-free survival up to approximately 24months PFS, assessed by the investigator as per RECIST v1.1
Trial Locations
- Locations (128)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Jiamusi Cancer Hospital
🇨🇳Jiamusi, Heilongjiang, 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
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liao Ning, China
Shenyang The Tenth People's Hospital
🇨🇳Shenyang, Liao Ning, 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
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
The 1st Affiliated Hospital of WMU
🇨🇳Wenzhou, Zhejiang, China
University Hospital Motol
🇨🇿Prague, Czechia
Kliniken der Stadt Cologne GmbH
🇩🇪Cologne, Germany
General Hospital of Athens "Alexandra"
🇬🇷Athens, Greece
Hospital St. Jansdal
🇳🇱Harderwijk, Netherlands
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
🇪🇸Cordoba, Spain
Hospital Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Quironsalud Sagrado Corazón
🇪🇸Sevilla, Spain
Hospital Marques de Valdecilla
🇪🇸Valdecilla, Spain
University Hospital La Fe
🇪🇸Valencia, Spain
The Second Xiangya Hospita
🇨🇳Changsha, Hunan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
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
Montefiore Medical Center
🇺🇸Bronx, New York, United States
New York City Health+HospitalsCorporation Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
Northwell Health
🇺🇸Queens, 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 am Worthersee, Austria
Klinikum Klagenfurt am Wörthersee
🇦🇹Klagenfurt am Wörthersee, Austria
The First People's Hospital Of Changde City
🇨🇳Changde, Hunan, China
Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie
🇦🇹Wien, Austria
Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology
🇦🇹Wien, 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, China
The First Affiliated Hospital of Chongqing Medical
🇨🇳Chongqing, Chongqing, 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
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
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
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, 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, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Wenzhou University Hospital
🇨🇳Wenzhou, Shanghai, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
The Second People's Hospital Of Yibin
🇨🇳Sichuan, Yibin, 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
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-Vítkovice, Czechia
University Hospital Motol (Pneumology Clinic 2.LF UK and FN Motol)
🇨🇿Prague, Czechia
General University hospital in Prague (Oncology department)
🇨🇿Praha 2, Czechia
University hospital Schleswig-Holstein
🇩🇪Lübeck-Travemünde, Germany
"Sotiria" Thoracic Diseases General Hospital of Athens
🇬🇷Athens, Greece
Fejer County Szent Gyorgy University Teaching Hospital
🇭🇺Szekesfehervar, Hungary
Pulmonary Institute of Torokbalint
🇭🇺Torokbalint, Hungary
Riga East University Hospital, Latvian Oncology Center
🇱🇻Riga, Latvia
Clinic of Oncology, Pauls Stradins Clinical university hospital
🇱🇻Riga, Latvia
Isala Hospital
🇳🇱Zwolle, Netherlands
MedPoloniaSp. z o.o.
🇵🇱Poznan, Poland
Lung and Chest Cancer Clinic, National Institute of Oncology
🇵🇱Warszawa, Poland