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.

View Full Description

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 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.

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 108 Locations for this study

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OPN-Glendale
Arcadia California, 91007, United States More Info
Anthony Lam
Contact
818-254-2526
OPN-Los Alamitos
Los Alamitos California, 90720, United States More Info
Vu Phan
Contact
818-254-2526
Southern California Permanente Group
Los Angeles California, 90034, United States More Info
Eric McGary
Contact
626-261-2864
Emad Ibrahim, MD, Inc
Redlands California, 92373, United States More Info
Emad Ibrahim
Contact
909-793-4336
Providence Medical Foundation
Santa Rosa California, 95403, United States More Info
Iran Anderson
Contact
707-521-3814
Lutheran Medical Center - Cancer Centers of Colorado
Golden Colorado, 80401, United States More Info
Karng Log
Contact
303-403-7333
Eastern Connecticut Hematology & Oncology Associates
Norwich Connecticut, 06360, United States More Info
Dennis Slater
Contact
860-866-8362
Cancer Specialists of North Florida
Jacksonville Florida, 32257, United States More Info
Mehdi Moezi
Contact
904-538-4488
Mid Florida Hematology and Oncology Center
Orange City Florida, 32763, United States More Info
Santosh Nair
Contact
386-538-3169
Advent Health Orlando
Orlando Florida, 32804, United States More Info
Tarek Mekhail
Contact
407-303-2024
Napa Research
Pompano Beach Florida, 33064, United States More Info
David Kahn
Contact
954-773-9890
Kansas University Mediacal Center
Fairway Kansas, 66205, United States More Info
Chao Huang
Contact
913-588-2459
Pontchartrain Cancer Center
Covington Louisiana, 70433, United States More Info
David Oubre
Contact
985-419-0025
Tulane University
New Orleans Louisiana, 70112, United States More Info
Mark Sides
Contact
504-988-6770
Health Partners
Bloomington Minnesota, 55425, United States More Info
Yan Ji
Contact
952-993-1555
Renown Health
Reno Nevada, 89502, United States More Info
Katherine Thomas
Contact
775-982-3684
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States More Info
Geregory Russo
Contact
603-653-9052
Montefiore Medical Center
Bronx New York, 10467, United States More Info
Nitin Ohri
Contact
952-993-1555
New York City Health+HospitalsCorporation Elmhurst Hospital Center
Elmhurst New York, 11373, United States More Info
Muhammad Perwaiz
Contact
844-692-4692
Northwell Health
Queens New York, 11040, United States More Info
Nagashree Seetharamu
Contact
516-734-8900
Cleveland Clinic Mercy Hospital
Canton Ohio, 44708, United States More Info
Mitchell Haut
Contact
330-489-1274
Gabrail Cancer Center
Canton Ohio, 44718, United States More Info
Nashat Gabrail
Contact
330-492-3345
Tricounty Hematology and Oncology Associates
Massillon Ohio, 44646, United States More Info
Nagaprasad Nagajothi
Contact
330-489-1274
Kaiser Permanente Northwest
Portland Oregon, 97229, United States More Info
Sandeep Mashru
Contact
503-331-2500
The Center for Cancer and Blood Disorders
Fort Worth Texas, 76104, United States More Info
Ray Page
Contact
817-759-7023
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Debbie Stroughter
Contact
713-792-7734
[email protected]
Jianjun Zhang
Principal Investigator
Millennium Research & Clinical Development
Houston Texas, 77090, United States More Info
Murtuza Bhuriwala
Contact
832-330-5090
Pro Research Tools, INC DBA Lumi Research
Kingwood Texas, 77339, United States More Info
Saleha Sajid
Contact
832-615-6090
The University of Texas - Hope Cancer Center
Tyler Texas, 75701, United States More Info
Arielle Lee
Contact
903-592-6152
Innova Schar Cancer Insitute
Fairfax Virginia, 22031, United States More Info
Janaki Subramanian
Contact
571-999-7271
Northwest Medical Specialties
Tacoma Washington, 98405, United States More Info
Andrea Veatch
Contact
233-380-5999
Klinikum Klagenfurt am Worthersee
Klagenfurt am Worthersee , 9020, Austria More Info
Markus Rauter
Contact
+43 463 538 313 03
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
Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology
Wien , 1210, Austria More Info
Maximilian Hochmair
Contact
+43 1 277 700 722 12
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
23868003
Queen Elizabeth Hospital
Hong Kong Hong Kong, 99907, China More Info
Lee Tin Yan
Contact
52782641
Queen Mary Hospital
Hong Kong Hong Kong, 99907, China More Info
Dennis Leung
Contact
22555102
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 (Clinic For Lung Diseases and Tuberculosis)
Brno , 625 0, Czechia More Info
Kristian Brat
Contact
+420 775 747 176
University Hospital Brno
Brno , 625 0, Czechia More Info
Kristian Brat
Contact
University Hospital Olomouc (Oncology Clinic)
Olomouc , 775 2, Czechia More Info
Bohuslav Melichar
Contact
+420 588 444 288
University Hospital Ostrava (oncology department)
Ostrava-Poruba , 57085, Czechia More Info
Kamila Resova
Contact
+420 597 372 123
University Hospital Ostrava
Ostrava-Poruba , , Czechia More Info
Kamila Resova
Contact
Nemocnice AGEL Ostrava-Vítkovice
Ostrava-Vitkovice , 703 0, Czechia More Info
Jaromir Roubec
Contact
+420 603 500 637
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
University Hospital Motol (Pneumology Clinic 2.LF UK and FN Motol)
Prague , , Czechia More Info
Leona Koubkova
Contact
+420 224 436 644
General University hospital in Prague (Oncology department)
Praha 2 , 128 0, Czechia More Info
Milada Zemanova
Contact
+420 224 966 405
Kliniken der Stadt Cologne GmbH
Cologne , 51109, Germany More Info
Eva Lotte Buchmeier
Contact
+49 221 8907 3250
University hospital Schleswig-Holstein
Lübeck-Travemünde , 23538, Germany More Info
Sabine Bohnet
Contact
+49 451 500 430 45
"Sotiria" Thoracic Diseases General Hospital of Athens
Athens , 115 2, Greece More Info
Konstantinos Syrigos
Contact
+30 6945210150
General Hospital of Athens "Alexandra"
Athens , 11528, Greece More Info
Flora Zagouri
Contact
+306946462998
Fejer County Szent Gyorgy University Teaching Hospital
Szekesfehervar , 8000, Hungary More Info
Zsolt Pápai Székely
Contact
+36 30 253 8757
Pulmonary Institute of Torokbalint
Torokbalint , 2045, Hungary More Info
Gabriella Gálffy
Contact
+36 30 951 3053
Riga East University Hospital, Latvian Oncology Center
Riga , LV 10, Latvia More Info
Zanete Zvirbule
Contact
+371 29536734
Clinic of Oncology, Pauls Stradins Clinical university hospital
Riga , LV-10, Latvia More Info
Aija Gerina Berzina
Contact
+ 371 670 694 57
Hospital St. Jansdal
Harderwijk , 3844, Netherlands More Info
Lisenka Boom
Contact
+31 341 464 743
Isala Hospital
Zwolle , 8025, Netherlands More Info
Johannes Adrianus Stigt
Contact
+31 38 424 2456
MedPoloniaSp. z o.o.
Poznan , 60-69, Poland More Info
Rodryg Ramlau
Contact
+48 501 296 922
Lung and Chest Cancer Clinic, National Institute of Oncology
Warszawa , 02-78, Poland More Info
Marta Olszyna Serementa
Contact
+48 604 491 696
Hospital Universitario de Badajoz
Badajoz , 6006, Spain More Info
Marta Gonzalez Cordero
Contact
+34 924218100
Hospital German Trias i Pujol/ ICO Badalona
Badalona , 8916, Spain More Info
Enric Carcereny
Contact
+34 34934978925
Hospital de la Santa Creu i Sant Pau
Barcelona , 8025, Spain More Info
Margarita Majem Tarruella
Contact
+34 935537148
Hospital Universitario Reina Sofía
Cordoba , 14004, Spain More Info
Isidoro Carlos Barneto Aranda
Contact
+34 957011464
Hospital Gregorio Marañon
Madrid , 28007, Spain More Info
Rosa Alvarez
Contact
+34 91 426 95 22
Hospital Universitario Puerta de Hierro
Madrid , 2822, Spain More Info
Mariano Provencio
Contact
+34 91 191 7418
Hospital Quironsalud Sagrado Corazón
Sevilla , 41013, Spain More Info
Juan Antonio Virizuela Echaburu
Contact
+34 629245701
Hospital Marques de Valdecilla
Valdecilla , 39008, Spain More Info
Marta Lopez Brea
Contact
+34 655379579
University Hospital La Fe
Valencia , 46026, Spain More Info
Oscar Jose Juan Vidal
Contact
+34 961245872

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

How clear is this clinincal trial information?

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