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

January 12, 2026 updated by: Shanghai Henlius Biotech

A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

511

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Klagenfurt, Austria, 9020
        • Klinikum Klagenfurt am Wörthersee
      • Vienna, Austria, 1210
        • Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie
      • Vienna, Austria, 1210
        • Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology
  • China
    • Anhui
      • Bengbu, Anhui, China, 233099
        • The First Affiliated Hospital of Bengbu Medical College
      • Hefei, Anhui, China, 230031
        • Anhui Chest Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer hospital
      • Beijing, Beijing Municipality, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Chongqing University Cancer Hospital
      • Chongqing, Chongqing Municipality, China, 400016
        • The First Affiliated Hospital of Chongqing Medical
    • Fujian
      • Fuzhou, Fujian, China, 350011
        • Fujian Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510030
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shenzhen Hospital
    • Guangxi
      • Guilin, Guangxi, China, 541100
        • The Second Affiliated Hospital of Guilin Medical University
      • Nanning, Guangxi, China, 530021
        • Guangxi Medical University Cancer Hospital
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510095
        • Gungzhouyikedaxuefushuzhongliuyiyuan
    • Hebei
      • Baoding, Hebei, China, 071000
        • Affiliated Hospital of Hebei University
      • Cangzhou, Hebei, China, 061019
        • Cangzhou People's Hospital
      • Tangshan, Hebei, China, 063001
        • Tangshan People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital
      • Jiamusi, Heilongjiang, China, 154007
        • Jiamusi Cancer Hospital
    • Henan
      • Luoyang, Henan, China, 471000
        • The First Affiliated Hospital of Henan University of Science and Technology
      • Xinxiang, Henan, China, 453100
        • The First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
    • Hong Kong
      • Hong Kong, Hong Kong, China, 999077
        • Queen Elizabeth Hospital
      • Hong Kong, Hong Kong, China, 999077
        • Queen Mary Hospital
      • Hong Kong, Hong Kong, China, 999077
        • Hong Kong United Oncology Centre
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Taihe Hospital Affiliated Hospital of Hubei University of Medicine
      • Wuhan, Hubei, China, 430071
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
    • Hunan
      • Changde, Hunan, China, 415000
        • The First People's Hospital of Changde City
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
      • Changsha, Hunan, China, 410013
        • Xiangya Hospital Central South University
      • Changsha, Hunan, China, 410008
        • The Second Xiangya Hospita
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Xuzhou Central Hospital
      • Yangzhou, Jiangsu, China, 210008
        • Northern Jiangsu People's Hospital
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341001
        • First Affiliated Hospital of Gannan Medical University
      • Ganzhou, Jiangxi, China, 341005
        • Ganzhou Cancer Hospital
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130000
        • Jilin Cancer Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Liaoning cancer Hospital & Institute
      • Shenyang, Liaoning, China, 110044
        • Shenyang The Tenth People's Hospital
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
      • Linyi, Shandong, China, 276002
        • Linyi Tumor Hospital
      • Qingdao, Shandong, China, 266031
        • Affiliated Hospital of Qingdao University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai Municipality, China, 200030
        • Shanghai Chest Hospital
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital of Fudan University
      • Wenzhou, Shanghai Municipality, China, 200032
        • Wenzhou University Hospital
    • Shanxi
      • Baoji, Shanxi, China, 721008
        • Baoji Central Hospital
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincial Cancer Hospital
      • Xi’an, Shanxi, China, 710061
        • First Affiliated Hospital of Xi'an JiaoTong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University Cancer Institute & Hospital
    • Yibin
      • Sichuan, Yibin, China, 644000
        • The Second People's Hospital of Yibin
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Yunnan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310000
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310003
        • Yuhang Branch of the First Affiliated Hospital of Zhejiang University
      • Taizhou, Zhejiang, China, 317000
        • Taizhou Hospital of Zhejiang Province
      • Wenzhou, Zhejiang, China, 325000
        • The 1st Affiliated Hospital of WMU
  • Czechia
      • Brno, Czechia, 625 00
        • University Hospital Brno
      • Brno, Czechia, 625 00
        • University Hospital Brno (Clinic For Lung Diseases and Tuberculosis)
      • Olomouc, Czechia, 775 20
        • University Hospital Olomouc (Oncology Clinic)
      • Ostrava-Poruba, Czechia
        • University Hospital Ostrava
      • Ostrava-Poruba, Czechia, 570852
        • University Hospital Ostrava (oncology department)
      • Ostrava-Vitkovice, Czechia, 703 00
        • Nemocnice AGEL Ostrava-Vitkovice
      • Ostrava-Vítkovice, Czechia, 703 00
        • Nemocnice AGEL Ostrava-Vitkovice
      • Prague, Czechia, 150 06
        • University Hospital Motol
      • Prague, Czechia
        • University Hospital Motol (Pneumology Clinic 2.LF UK and FN Motol)
      • Prague, Czechia, 128 08
        • General University hospital in Prague (Oncology department)
  • Germany
      • Cologne, Germany, 51109
        • Kliniken der Stadt Cologne GmbH
      • Travemünde, Germany, 23538
        • University Hospital Schleswig-Holstein
  • Greece
      • Athens, Greece, 11528
        • General Hospital of Athens "Alexandra"
      • Athens, Greece, 115 27
        • "Sotiria" Thoracic Diseases General Hospital of Athens
  • Hungary
      • Székesfehérvár, Hungary, 8000
        • Fejer County Szent Gyorgy University Teaching Hospital
      • Törökbálint, Hungary, 2045
        • Pulmonary Institute of Torokbalint
  • Latvia
      • Riga, Latvia, LV 1079
        • Riga East University Hospital, Latvian Oncology Center
      • Riga, Latvia, LV-1002
        • Clinic of Oncology, Pauls Stradins Clinical university hospital
  • Netherlands
      • Harderwijk, Netherlands, 3844
        • Hospital St. Jansdal
      • Zwolle, Netherlands, 8025
        • Isala Hospital
  • Poland
      • Poznan, Poland, 60-693
        • MedPoloniaSp. z o.o.
      • Warsaw, Poland, 02-781
        • Lung and Chest Cancer Clinic, National Institute of Oncology
  • Spain
      • Badajoz, Spain, 6006
        • Hospital Universitario de Badajoz
      • Badalona, Spain, 8916
        • Hospital German Trias i Pujol/ ICO Badalona
      • Barcelona, Spain, 8025
        • Hospital De La Santa Creu I Sant Pau
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofía
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain, 2822
        • Hospital Universitario Puerta de Hierro
      • Seville, Spain, 41013
        • Hospital Quironsalud Sagrado Corazón
      • Valdecilla, Spain, 39008
        • Hospital Marques de Valdecilla
      • Valencia, Spain, 46026
        • University Hospital La Fe
  • United States
    • California
      • Arcadia, California, United States, 91007
        • OPN-Glendale
      • Los Alamitos, California, United States, 90720
        • OPN-Los Alamitos
      • Los Angeles, California, United States, 90034
        • Southern California Permanente Group
      • Redlands, California, United States, 92373
        • Emad Ibrahim, MD, INC
      • Santa Rosa, California, United States, 95403
        • Providence Medical Foundation
    • Colorado
      • Golden, Colorado, United States, 80401
        • Lutheran Medical Center - Cancer Centers of Colorado
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology & Oncology Associates
    • Florida
      • Jacksonville, Florida, United States, 32257
        • Cancer Specialists of North Florida
      • Orange City, Florida, United States, 32763
        • Mid Florida Hematology and Oncology Center
      • Orlando, Florida, United States, 32804
        • Advent Health Orlando
      • Pompano Beach, Florida, United States, 33064
        • NAPA Research
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Kansas University Mediacal Center
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Pontchartrain Cancer Center
      • New Orleans, Louisiana, United States, 70112
        • Tulane University
    • Minnesota
      • Bloomington, Minnesota, United States, 55425
        • Health Partners
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Health
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • Elmhurst, New York, United States, 11373
        • New York City Health+HospitalsCorporation Elmhurst Hospital Center
      • Queens, New York, United States, 11040
        • Northwell Health
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Ohio
      • Canton, Ohio, United States, 44708
        • Cleveland Clinic Mercy Hospital
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Massillon, Ohio, United States, 44646
        • Tricounty Hematology and Oncology Associates
    • Oregon
      • Portland, Oregon, United States, 97229
        • Kaiser Permanente Northwest
    • Texas
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77090
        • Millennium Research & Clinical Development
      • Kingwood, Texas, United States, 77339
        • Pro Research Tools, INC DBA Lumi Research
      • Tyler, Texas, United States, 75701
        • The University of Texas - Hope Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Innova Schar Cancer Insitute
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Criteria:

  1. Histologically or cytologically confirmed mixed SCLC.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Radiation: Prophylactic Cranial Irradiation (PCI)
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
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
Experimental: 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.
Radiation: Prophylactic Cranial Irradiation (PCI)
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
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: HLX10

Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

300mg Q3W

Other Names:
  • Serplulimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: up to approximately 24months
PFS, assessed by the Blinded Independent Central Review (BICR) as per RECIST v1.1
up to approximately 24months
Overall survival (OS)
Time Frame: up to 36 months
the time from randomization to death due to any cause
up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: up to approximately 24months
PFS, assessed by the investigator as per RECIST v1.1
up to approximately 24months
Objective response rate (ORR)
Time Frame: up to approximately 24months
ORR, assessed by the BICR and investigator as per RECIST 1.1
up to approximately 24months
Duration of remission (DOR)
Time Frame: up to approximately 24months
DOR, assessed by the BICR and investigator as per RECIST 1.1
up to approximately 24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Henlius Biotech

Investigators

  • Principal Investigator: Ying Cheng, Jilin Provincial Tumor Hospital
  • Principal Investigator: Jinming Yu, MD, Shandong Cancer Hospital & Institute-department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Estimated)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLX10-020-SCLC302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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