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Limited-Stage Small Cell Lung CancerPhase 3NCT05353257

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

A Phase 3 study testing HLX10, carboplatin/cisplatin-etoposide and Thoracic radiotherapy in people with Limited-Stage Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 129 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Limited-Stage Small Cell Lung Cancer
What is being tested?
HLX10, carboplatin/cisplatin-etoposide and Thoracic radiotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
511 participants
Where
129 sitesin 11 countries
Study dates
17 May 2022to 30 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

129 sites in 11 countries.

129 sites in 11 countries

China63 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071000

  • Baoji Central Hospital

    Baoji, Shanxi, 721008

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233099

  • Cangzhou People's Hospital

    Cangzhou, Hebei, 061019

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

  • The First People's Hospital Of Changde City

    Changde, Hunan, 415000

  • The Second Xiangya Hospita

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital of Chongqing Medical

    Chongqing, Chongqing Municipality, 400016

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350011

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341001

  • Ganzhou Cancer Hospital

    Ganzhou, Jiangxi, 341005

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510000

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510030

  • Gungzhouyikedaxuefushuzhongliuyiyuan

    Guangzhou, Guangzhou, 510095

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541100

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

  • Yuhang Branch of the First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Anhui Chest Hospital

    Hefei, Anhui, 230031

  • Hong Kong United Oncology Centre

    Hong Kong, Hong Kong, 999077

  • Queen Elizabeth Hospital

    Hong Kong, Hong Kong, 999077

  • Queen Mary Hospital

    Hong Kong, Hong Kong, 999077

  • Jiamusi Cancer Hospital

    Jiamusi, Heilongjiang, 154007

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

  • Linyi Tumor Hospital

    Linyi, Shandong, 276002

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

    Luoyang, Henan, 471000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266031

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042

  • Shenyang The Tenth People's Hospital

    Shenyang, Liaoning, 110044

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • TaiHe Hospital Affiliated Hospital of Hubei University of Medicine

    Shiyan, Hubei, 442000

  • The Second People's Hospital Of Yibin

    Sichuan, Yibin, 644000

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317000

  • Tangshan People's Hospital

    Tangshan, Hebei, 063001

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Wenzhou University Hospital

    Wenzhou, Shanghai Municipality, 200032

  • The 1st Affiliated Hospital of WMU

    Wenzhou, Zhejiang, 325000

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

    Wuhan, Hubei, 430030

  • Zhongnan hospital of wuhan university

    Wuhan, Hubei, 430071

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000

  • Northern Jiangsu people's Hospital

    Yangzhou, Jiangsu, 210008

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

United States31 sites

  • OPN-Glendale

    Arcadia, California, 91007

  • Health Partners

    Bloomington, Minnesota, 55425

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Pontchartrain Cancer Center

    Covington, Louisiana, 70433

  • New York City Health+HospitalsCorporation Elmhurst Hospital Center

    Elmhurst, New York, 11373

  • Innova Schar Cancer Insitute

    Fairfax, Virginia, 22031

  • Kansas University Mediacal Center

    Fairway, Kansas, 66205

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Lutheran Medical Center - Cancer Centers of Colorado

    Golden, Colorado, 80401

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Millennium Research & Clinical Development

    Houston, Texas, 77090

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32257

  • Pro Research Tools, INC DBA Lumi Research

    Kingwood, Texas, 77339

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • OPN-Los Alamitos

    Los Alamitos, California, 90720

  • Southern California Permanente Group

    Los Angeles, California, 90034

  • Tricounty Hematology and Oncology Associates

    Massillon, Ohio, 44646

  • Tulane University

    New Orleans, Louisiana, 70112

  • Eastern Connecticut Hematology & Oncology Associates

    Norwich, Connecticut, 06360

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763

  • Advent Health Orlando

    Orlando, Florida, 32804

  • Napa Research

    Pompano Beach, Florida, 33064

  • Kaiser Permanente Northwest

    Portland, Oregon, 97229

  • Northwell Health

    Queens, New York, 11040

  • Emad Ibrahim, MD, Inc

    Redlands, California, 92373

  • Renown Health

    Reno, Nevada, 89502

  • Providence Medical Foundation

    Santa Rosa, California, 95403

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • The University of Texas - Hope Cancer Center

    Tyler, Texas, 75701

Other trials in United States

Czechia10 sites

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

    Brno, 625 00

  • University Hospital Brno

    Brno, 625 00

  • University Hospital Olomouc (Oncology Clinic)

    Olomouc, 775 20

  • University Hospital Ostrava (oncology department)

    Ostrava-Poruba, 570852

  • University Hospital Ostrava

    Ostrava-Poruba

  • Nemocnice AGEL Ostrava-Vítkovice

    Ostrava-Vitkovice, 703 00

  • Nemocnice AGEL Ostrava-Vítkovice

    Ostrava-Vítkovice, 703 00

  • General University hospital in Prague (Oncology department)

    Prague, 128 08

  • University Hospital Motol

    Prague, 150 06

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

    Prague

Other trials in Czechia

Spain9 sites

  • Hospital Universitario de Badajoz

    Badajoz, 6006

  • Hospital German Trias i Pujol/ ICO Badalona

    Badalona, 8916

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8025

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Puerta de Hierro

    Madrid, 2822

  • Hospital Quironsalud Sagrado Corazón

    Seville, 41013

  • Hospital Marques de Valdecilla

    Valdecilla, 39008

  • University Hospital La Fe

    Valencia, 46026

Other trials in Spain

Austria4 sites

  • Klinikum Klagenfurt am Worthersee

    Klagenfurt, 9020

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020

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

    Vienna, 1210

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

    Vienna, 1210

Other trials in Austria

Germany2 sites

  • Kliniken der Stadt Cologne GmbH

    Cologne, 51109

  • University hospital Schleswig-Holstein

    Travemünde, 23538

Other trials in Germany

Greece2 sites

  • "Sotiria" Thoracic Diseases General Hospital of Athens

    Athens, 115 27

  • General Hospital of Athens "Alexandra"

    Athens, 11528

Other trials in Greece

Hungary2 sites

  • Fejer County Szent Gyorgy University Teaching Hospital

    Székesfehérvár, 8000

  • Pulmonary Institute of Torokbalint

    Törökbálint, 2045

Other trials in Hungary

Latvia2 sites

  • Riga East University Hospital, Latvian Oncology Center

    Riga, LV 1079

  • Clinic of Oncology, Pauls Stradins Clinical university hospital

    Riga, LV-1002

Other trials in Latvia

Netherlands2 sites

  • Hospital St. Jansdal

    Harderwijk, 3844

  • Isala Hospital

    Zwolle, 8025

Other trials in Netherlands

Poland2 sites

  • MedPoloniaSp. z o.o.

    Poznan, 60-693

  • Lung and Chest Cancer Clinic, National Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

About this study

Official title: 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.

Read the 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).

Being tested
HLX10, carboplatin/cisplatin-etoposide, Thoracic radiotherapy, Placebo, Prophylactic Cranial Irradiation (PCI)
Keywords
Limited-Stage Small Cell Lung Cancer, Serplulimab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX10Drug

    Also called Serplulimab

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

    300mg Q3W

  • carboplatin/cisplatin-etoposideDrug

    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.

  • Thoracic radiotherapyRadiation

    Standard Thoracic Radiotherapy

  • PlaceboDrug

    Placebo Q3W

  • Prophylactic Cranial Irradiation (PCI)Radiation

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

Study groups in NCT05353257
Study groupRoleWhat they receive
Serplulimab + carboplatin/cisplatin-etoposide + radiotherapyExperimentalParticipants 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.
Receives: Drug: HLX10; Drug: carboplatin/cisplatin-etoposide; Radiation: Thoracic radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI)
placebo + carboplatin/cisplatin-etoposide + radiotherapyPlacebo comparatorParticipants 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.
Receives: Drug: carboplatin/cisplatin-etoposide; Radiation: Thoracic radiotherapy; Drug: Placebo; Radiation: Prophylactic Cranial Irradiation (PCI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    PFS, assessed by the Blinded Independent Central Review (BICR) as per RECIST v1.1

    Measured: up to approximately 24months

  2. Overall survival (OS)

    the time from randomization to death due to any cause

    Measured: up to 36 months

Secondary outcomes (3)

  1. Progression-free survival

    PFS, assessed by the investigator as per RECIST v1.1

    Measured: up to approximately 24months

  2. Objective response rate (ORR)

    ORR, assessed by the BICR and investigator as per RECIST 1.1

    Measured: up to approximately 24months

  3. Duration of remission (DOR)

    DOR, assessed by the BICR and investigator as per RECIST 1.1

    Measured: up to approximately 24months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start17 May 2022
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05353257
Sponsor's protocol ID
HLX10-020-SCLC302
Status last verified
Jan 2026
First submitted
25 Apr 2022
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HLX10, carboplatin/cisplatin-etoposide and Thoracic radiotherapy in people with Limited-Stage Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 129 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in China, United States, Czechia, Spain, Austria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: up to approximately 24months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05353257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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