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

Last updated: January 23, 2025
Sponsor: Shanghai Henlius Biotech
Overall Status: Active - Not Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Treatment

Placebo

carboplatin/cisplatin-etoposide

Thoracic radiotherapy

Clinical Study ID

NCT05353257
HLX10-020-SCLC302
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, aged ≥18 years when signing the ICF.

  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

Exclusion Criteria:

  1. Histologically or cytologically confirmed mixed SCLC.

  2. Subjects suitable for surgery. Subjects who are suitable for surgery but refusesurgical treatment can be included.

  3. Patients who have previously received systematic anti-tumor treatments for smallcell lung cancer, including but not limited to radiotherapy, chemotherapy, andimmunotherapy.

  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 maylead to a premature discontinuation.

Study Design

Total Participants: 511
Treatment Group(s): 6
Primary Treatment: Placebo
Phase: 3
Study Start date:
May 17, 2022
Estimated Completion Date:
December 30, 2026

Study 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).

Connect with a study center

  • Klinikum Klagenfurt am Worthersee

    Klagenfurt am Worthersee, 9020
    Austria

    Site Not Available

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt am Wörthersee, 9020
    Austria

    Site Not Available

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

    Wien, 1210
    Austria

    Site Not Available

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

    Wien, 1210
    Austria

    Site Not Available

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233099
    China

    Site Not Available

  • Anhui Chest Hospital

    Hefei, Anhui 230031
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Site Not Available

  • Chinese PLA General Hospital

    Beijing, Beijing 100038
    China

    Site Not Available

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical

    Chongqing, Chongqing 400016
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350011
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • 1st Hospital Guangdong Pharma

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong 510030
    China

    Site Not Available

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Zhongshandaxuefushuzhongyiyuan

    Guangzhou, Guangdong 510030
    China

    Site Not Available

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong 518036
    China

    Site Not Available

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi 541100
    China

    Site Not Available

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Gungzhouyikedaxuefushuzhongliuyiyuan

    Guangzhou, Guangzhou 510095
    China

    Site Not Available

  • Affiliated Hospital of Hebei University

    Baoding, Hebei 071000
    China

    Site Not Available

  • Cangzhou People's Hospital

    Cangzhou, Hebei 061019
    China

    Site Not Available

  • Tangshan People's Hospital

    Tangshan, Hebei 063001
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • Jiamusi Cancer Hospital

    Jiamusi, Heilongjiang 154007
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 471000
    China

    Site Not Available

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan 453100
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Queen Elizabeth Hospital

    Hong Kong, Hong Kong 999077
    China

    Site Not Available

  • Queen Mary Hospital

    Hong Kong, Hong Kong 999077
    China

    Site Not Available

  • Hong Kong United Oncology Centre

    Hong kong, Hong Kong 999077
    China

    Site Not Available

  • TaiHe Hospital Affiliated Hospital of Hubei University of Medicine

    Shiyan, Hubei 442000
    China

    Site Not Available

  • Taihe Hospital affliated of Hubei Universiry of Medicine

    Shiyan, Hubei 442000
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Site Not Available

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

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Wuhan Tongji Hospital

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Zhongnan hospital of wuhan university

    Wuhan, Hubei 430071
    China

    Site Not Available

  • Changde First People's Hospital

    Changde, Hunan 415000
    China

    Site Not Available

  • The First People's Hospital Of Changde City

    Changde, Hunan 415000
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • The Second Xiangya Hospita

    Changsha, Hunan 410008
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 010000
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • Jiangsu Subei people's Hospital

    Yangzhou, Jiangsu 210008
    China

    Site Not Available

  • Northern Jiangsu people's Hospital

    Yangzhou, Jiangsu 210008
    China

    Site Not Available

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi 341001
    China

    Site Not Available

  • Ganzhou Cancer Hospital

    Ganzhou, Jiangxi 341005
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun, Jilin 130000
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liao Ning 110042
    China

    Site Not Available

  • Shenyang Tenth People's Hospital

    Shenyang, Liao Ning 110044
    China

    Site Not Available

  • Shenyang The Tenth People's Hospital

    Shenyang, Liao Ning 110044
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Linyi Tumor Hospital

    Linyi, Shandong 276002
    China

    Site Not Available

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266031
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Wenzhou University Hospital

    Wenzhou, Shanghai 200032
    China

    Site Not Available

  • Baoji Central Hospital

    Baoji, Shanxi 721008
    China

    Site Not Available

  • Shanxi Provincial Cancer Hospital

    TaiYuan, Shanxi 030013
    China

    Site Not Available

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • The Second People's Hospital Of Yibin

    Sichuan, Yibin 644000
    China

    Site Not Available

  • Yunnan Cancer Hospital

    Kunming, Yunnan 650118
    China

    Site Not Available

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • The Fist Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Yuhang Branch of the First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310005
    China

    Site Not Available

  • Zhejiang Tumor Hospital

    Hangzhou, Zhejiang 310005
    China

    Site Not Available

  • Zhejiang University School of Medicine Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang 317000
    China

    Site Not Available

  • The 1st Affiliated Hospital of WMU

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • University Hospital Brno

    Brno, 625 00
    Czechia

    Site Not Available

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

    Brno, 625 00
    Czechia

    Site Not Available

  • University Hospital Olomouc (Oncology Clinic)

    Olomouc, 775 20
    Czechia

    Site Not Available

  • University Hospital Ostrava

    Ostrava-Poruba,
    Czechia

    Site Not Available

  • University Hospital Ostrava (oncology department)

    Ostrava-Poruba, 570852
    Czechia

    Site Not Available

  • Nemocnice AGEL Ostrava-Vítkovice

    Ostrava-Vitkovice, 703 00
    Czechia

    Site Not Available

  • Nemocnice AGEL Ostrava-Vítkovice

    Ostrava-Vítkovice, 703 00
    Czechia

    Site Not Available

  • University Hospital Motol

    Prague, 150 06
    Czechia

    Site Not Available

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

    Prague,
    Czechia

    Site Not Available

  • General University hospital in Prague (Oncology department)

    Praha 2, 128 08
    Czechia

    Site Not Available

  • Kliniken der Stadt Cologne GmbH

    Cologne, 51109
    Germany

    Site Not Available

  • University hospital Schleswig-Holstein

    Lübeck-Travemünde, 23538
    Germany

    Site Not Available

  • "Sotiria" Thoracic Diseases General Hospital of Athens

    Athens, 115 27
    Greece

    Site Not Available

  • General Hospital of Athens "Alexandra"

    Athens, 11528
    Greece

    Site Not Available

  • Fejer County Szent Gyorgy University Teaching Hospital

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Pulmonary Institute of Torokbalint

    Torokbalint, 2045
    Hungary

    Site Not Available

  • Clinic of Oncology, Pauls Stradins Clinical university hospital

    Riga, LV-1002
    Latvia

    Site Not Available

  • Riga East University Hospital, Latvian Oncology Center

    Riga, LV 1079
    Latvia

    Site Not Available

  • Hospital St. Jansdal

    Harderwijk, 3844
    Netherlands

    Site Not Available

  • Isala Hospital

    Zwolle, 8025
    Netherlands

    Site Not Available

  • MedPoloniaSp. z o.o.

    Poznan, 60-693
    Poland

    Site Not Available

  • Lung and Chest Cancer Clinic, National Institute of Oncology

    Warszawa, 02-781
    Poland

    Site Not Available

  • Hospital Universitario de Badajoz

    Badajoz, 6006
    Spain

    Site Not Available

  • Hospital German Trias i Pujol/ ICO Badalona

    Badalona, 8916
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8025
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Madrid, 2822
    Spain

    Site Not Available

  • Hospital Quironsalud Sagrado Corazón

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Marques de Valdecilla

    Valdecilla, 39008
    Spain

    Site Not Available

  • University Hospital La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Providence Medical Group

    Anaheim, California 92805
    United States

    Site Not Available

  • OPN-Glendale

    Arcadia, California 91007
    United States

    Site Not Available

  • OPN-Los Alamitos

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Southern California Permanente Group

    Los Angeles, California 90034
    United States

    Site Not Available

  • Research Site

    Orange, California 32763
    United States

    Site Not Available

  • Kaiser Permanente Research

    Pasadena, California 91101
    United States

    Site Not Available

  • Emad Ibrahim, MD, INC-Redlands Community

    Redlands, California 92373
    United States

    Site Not Available

  • Emad Ibrahim, MD, Inc

    Redlands, California 92373
    United States

    Site Not Available

  • Providence Medical Foundation

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Research Site

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Lutheran Medical Center - Cancer Centers of Colorado

    Golden, Colorado 80401
    United States

    Site Not Available

  • Eastern Connecticut Hematology & Oncology Associates

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • Cancer Specialists of North Florida

    Jacksonville, Florida 32257
    United States

    Site Not Available

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Site Not Available

  • Advent Health Orlando

    Orlando, Florida 32804
    United States

    Site Not Available

  • Napa Research

    Pompano Beach, Florida 33064
    United States

    Site Not Available

  • Kansas University Mediacal Center

    Fairway, Kansas 66205
    United States

    Site Not Available

  • Pontchartrain Cancer Center

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Tulane University

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Health Partners

    Bloomington, Minnesota 55425
    United States

    Site Not Available

  • Renown Health

    Reno, Nevada 89502
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • New York City Health+HospitalsCorporation Elmhurst Hospital Center

    Elmhurst, New York 11373
    United States

    Site Not Available

  • Northwell Health

    Queens, New York 11040
    United States

    Site Not Available

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio 44708
    United States

    Site Not Available

  • Gabrail Cancer Center

    Canton, Ohio 44718
    United States

    Site Not Available

  • Tricounty Hematology and Oncology Associates

    Massillon, Ohio 44646
    United States

    Site Not Available

  • Kaiser Permanente Northwest

    Portland, Oregon 97229
    United States

    Site Not Available

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Ascend Pharma Holdings

    Houston, Texas 77015
    United States

    Site Not Available

  • Millennium Research & Clinical Development

    Houston, Texas 77090
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Pro Research Tools, INC DBA Lumi Research

    Kingwood, Texas 77339
    United States

    Site Not Available

  • The University of Texas - Hope Cancer Center

    Tyler, Texas 75701
    United States

    Site Not Available

  • The University of Texas at Tyler

    Tyler, Texas 75701
    United States

    Site Not Available

  • Innova Schar Cancer Insitute

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Northwest Medical Specialties

    Tacoma, Washington 98405
    United States

    Site Not Available

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