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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

511

Participants

Timeline

Start Date

May 17, 2022

Primary Completion Date

July 30, 2025

Study Completion Date

December 30, 2026

Conditions
Limited-Stage Small Cell Lung Cancer
Interventions
DRUG

HLX10

"Serplulimab is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc.~300mg Q3W"

DRUG

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."

RADIATION

Thoracic radiotherapy

Standard Thoracic Radiotherapy

DRUG

Placebo

Placebo Q3W

RADIATION

Prophylactic Cranial Irradiation (PCI)

PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.

Trial Locations (129)

1210

Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie, Vienna

Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology, Vienna

2045

Pulmonary Institute of Torokbalint, Törökbálint

2822

Hospital Universitario Puerta de Hierro, Madrid

3844

Hospital St. Jansdal, Harderwijk

6006

Hospital Universitario de Badajoz, Badajoz

8000

Fejer County Szent Gyorgy University Teaching Hospital, Székesfehérvár

8025

Isala Hospital, Zwolle

Hospital de la Santa Creu i Sant Pau, Barcelona

8916

Hospital German Trias i Pujol/ ICO Badalona, Badalona

9020

Klinikum Klagenfurt am Worthersee, Klagenfurt

Klinikum Klagenfurt am Wörthersee, Klagenfurt

10467

Montefiore Medical Center, The Bronx

11040

Northwell Health, Queens

11373

New York City Health+HospitalsCorporation Elmhurst Hospital Center, Elmhurst

11528

"General Hospital of Athens Alexandra", Athens

14004

Hospital Universitario Reina Sofía, Córdoba

22031

Innova Schar Cancer Insitute, Fairfax

23538

University hospital Schleswig-Holstein, Travemünde

28007

Hospital Gregorio Marañon, Madrid

32257

Cancer Specialists of North Florida, Jacksonville

32763

Mid Florida Hematology and Oncology Center, Orange City

32804

Advent Health Orlando, Orlando

33064

Napa Research, Pompano Beach

39008

Hospital Marques de Valdecilla, Valdecilla

41013

Hospital Quironsalud Sagrado Corazón, Seville

44646

Tricounty Hematology and Oncology Associates, Massillon

44708

Cleveland Clinic Mercy Hospital, Canton

44718

Gabrail Cancer Center, Canton

46026

University Hospital La Fe, Valencia

51109

Kliniken der Stadt Cologne GmbH, Cologne

55425

Health Partners, Bloomington

66205

Kansas University Mediacal Center, Fairway

70112

Tulane University, New Orleans

70433

Pontchartrain Cancer Center, Covington

75701

The University of Texas - Hope Cancer Center, Tyler

76104

The Center for Cancer and Blood Disorders, Fort Worth

77030

The University of Texas MD Anderson Cancer Center, Houston

77090

Millennium Research & Clinical Development, Houston

77339

Pro Research Tools, INC DBA Lumi Research, Kingwood

80401

Lutheran Medical Center - Cancer Centers of Colorado, Golden

89502

Renown Health, Reno

90034

Southern California Permanente Group, Los Angeles

90720

OPN-Los Alamitos, Los Alamitos

91007

OPN-Glendale, Arcadia

92373

Emad Ibrahim, MD, Inc, Redlands

95403

Providence Medical Foundation, Santa Rosa

97229

Kaiser Permanente Northwest, Portland

98405

Northwest Medical Specialties, Tacoma

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

100142

Beijing Cancer Hospital, Beijing

110042

Liaoning Cancer Hospital & Institute, Shenyang

110044

Shenyang The Tenth People's Hospital, Shenyang

130000

Jilin Cancer Hospital, Changchun

150000

Harbin Medical University Cancer Hospital, Harbin

154007

Jiamusi Cancer Hospital, Jiamusi

200030

Shanghai Chest Hospital, Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

Zhongshan Hospital of Fudan University, Shanghai

Wenzhou University Hospital, Wenzhou

210008

Northern Jiangsu people's Hospital, Yangzhou

221000

Xuzhou Central Hospital, Xuzhou

230031

Anhui Chest Hospital, Hefei

233099

The First Affiliated Hospital of Bengbu Medical College, Bengbu

250012

Qilu Hospital of Shandong University, Jinan

250117

Shandong Cancer Hospital, Jinan

266031

Affiliated Hospital of Qingdao University, Qingdao

276002

Linyi Tumor Hospital, Linyi

300052

Tianjin Medical University Cancer Institute & Hospital, Tianjin

Tianjin Medical University General Hospital, Tianjin

310000

Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou

310003

Yuhang Branch of the First Affiliated Hospital of Zhejiang University, Hangzhou

310005

Zhejiang Cancer Hospital, Hangzhou

310009

The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

317000

Taizhou Hospital of Zhejiang Province, Taizhou

325000

The 1st Affiliated Hospital of WMU, Wenzhou

330006

The First Affiliated Hospital of Nanchang University, Nanchang

341001

First Affiliated Hospital of Gannan Medical University, Ganzhou

341005

Ganzhou Cancer Hospital, Ganzhou

350011

Fujian Cancer Hospital, Fuzhou

400016

The First Affiliated Hospital of Chongqing Medical, Chongqing

400030

Chongqing University Cancer Hospital, Chongqing

410008

The Second Xiangya Hospita, Changsha

410013

Hunan Cancer Hospital, Changsha

Xiangya Hospital Central South University, Changsha

415000

The First People's Hospital Of Changde City, Changde

430030

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan

430071

Zhongnan hospital of wuhan university, Wuhan

430079

Hubei Cancer Hospital, Wuhan

442000

TaiHe Hospital Affiliated Hospital of Hubei University of Medicine, Shiyan

450008

Henan Cancer Hospital, Zhengzhou

450052

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

453100

The First Affiliated Hospital of Xinxiang Medical University, Xinxiang

471000

The First Affiliated Hospital of Henan University of Science and Technology, Luoyang

510000

The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou

510030

Sun Yat-Sen University Cancer Center, Guangzhou

510095

Gungzhouyikedaxuefushuzhongliuyiyuan, Guangzhou

518036

Peking University Shenzhen Hospital, Shenzhen

530021

Guangxi Medical University Cancer Hospital, Nanning

541100

The Second Affiliated Hospital of Guilin Medical University, Guilin

570852

University Hospital Ostrava (oncology department), Ostrava-Poruba

610041

West China Hospital of Sichuan University, Chengdu

644000

The Second People's Hospital Of Yibin, Sichuan

650118

Yunnan Cancer Hospital, Kunming

710061

First Affiliated Hospital of Xi'an Jiaotong University, Xi’an

721008

Baoji Central Hospital, Baoji

999077

Hong Kong United Oncology Centre, Hong Kong

Queen Elizabeth Hospital, Hong Kong

Queen Mary Hospital, Hong Kong

06360

Eastern Connecticut Hematology & Oncology Associates, Norwich

03756

Dartmouth Hitchcock Medical Center, Lebanon

071000

Affiliated Hospital of Hebei University, Baoding

061019

Cangzhou People's Hospital, Cangzhou

063001

Tangshan People's Hospital, Tangshan

030013

Shanxi Provincial Cancer Hospital, Taiyuan

625 00

University Hospital Brno (Clinic For Lung Diseases and Tuberculosis), Brno

University Hospital Brno, Brno

775 20

University Hospital Olomouc (Oncology Clinic), Olomouc

Unknown

University Hospital Ostrava, Ostrava-Poruba

University Hospital Motol (Pneumology Clinic 2.LF UK and FN Motol), Prague

703 00

Nemocnice AGEL Ostrava-Vítkovice, Ostrava-Vitkovice

Nemocnice AGEL Ostrava-Vítkovice, Ostrava-Vítkovice

128 08

General University hospital in Prague (Oncology department), Prague

150 06

University Hospital Motol, Prague

115 27

"Sotiria Thoracic Diseases General Hospital of Athens", Athens

LV 1079

Riga East University Hospital, Latvian Oncology Center, Riga

LV-1002

Clinic of Oncology, Pauls Stradins Clinical university hospital, Riga

60-693

MedPoloniaSp. z o.o., Poznan

02-781

Lung and Chest Cancer Clinic, National Institute of Oncology, Warsaw

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY