NCT05353257Active, not recruitingPhase 3
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 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
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 511 (actual)
- First submitted
- 25 Apr 2022
- Start date
- 17 May 2022
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Shanghai Henlius Biotech
- Diseases
- Lung cancer
- NCT number
- NCT05353257
- EU CT number
- 2024-515047-31-00
- EudraCT number
- 2022-002226-27
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 511
- From 17 May 2022 to the primary completion date, 30 Jun 2026
- 152 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with other active malignancies within 5 years or at the same time.
- Subjects with known history of severe allergy to any monoclonal antibody.
Other
- Histologically or cytologically confirmed mixed SCLC.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (152)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stadt Wien Wiener Gesundheitsverbund Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| Affiliated Hospital of Hebei University Coordinator of this site? Confirm its status | Baoding | China | Unknown status |
| Baoji Central Hospital Coordinator of this site? Confirm its status | Baoji | China | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Bengbu Medical College Coordinator of this site? Confirm its status | Bengbu | China | Unknown status |
| Cangzhou People's Hospital Coordinator of this site? Confirm its status | Cangzhou | China | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The First People's Hospital of Changde City Coordinator of this site? Confirm its status | Changde | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Second Xiangya Hospita Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| First Affiliated Hospital Of Gannan Medical University Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| Ganzhou Cancer Hospital Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| The First Affiliated Hospital of Guangdong Pharmaceutical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Gungzhouyikedaxuefushuzhongliuyiyuan Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Affiliated Hospital of Guilin Medical University Coordinator of this site? Confirm its status | Guilin | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Yuhang Branch of the First Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Chest Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Hong Kong | China | Unknown status |
| Hong Kong United Oncology Centre Coordinator of this site? Confirm its status | Hong Kong | China | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | China | Unknown status |
| Jiamusi Cancer Hospital Coordinator of this site? Confirm its status | Jiamusi | China | Unknown status |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Linyi Tumor Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Guangxi Medical University Cancer Hospital Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Zhongshan Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Liaoning Cancer Hospital & Institute Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Shenyang The Tenth People's Hospital Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| TaiHe Hospital Affiliated Hospital of Hubei University of Medicine Coordinator of this site? Confirm its status | Shiyan | China | Unknown status |
| The Second People's Hospital Of Yibin Coordinator of this site? Confirm its status | Sichuan | China | Unknown status |
| Shanxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| Tangshan People's Hospital Coordinator of this site? Confirm its status | Tangshan | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The 1st Affiliated Hospital of WMU Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Wenzhou University Hospital Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The First Affiliated Hospital of Xinxiang Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| Xuzhou Central Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Northern Jiangsu People's Hospital Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Active, not recruiting |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Active, not recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Active, not recruiting |
| Nemocnice AGEL Ostrava - Vitkovice a.s. Coordinator of this site? Confirm its status | Ostrava | Czechia | Active, not recruiting |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Active, not recruiting |
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Active, not recruiting |
| Kliniken der Stadt Koeln gGmbH Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| Kaiserswerther Diakonie Coordinator of this site? Confirm its status | Duesseldorf | Germany | Active, not recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH Coordinator of this site? Confirm its status | Neuss | Germany | Active, not recruiting |
| Klinikum Nuernberg Coordinator of this site? Confirm its status | Nuremberg | Germany | Active, not recruiting |
| Onkologie Zentrum Sued MVZ GmbH Coordinator of this site? Confirm its status | Remscheid | Germany | Active, not recruiting |
| Onkologie Remscheid GmbH Coordinator of this site? Confirm its status | Remscheid | Germany | Active, not recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Active, not recruiting |
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | Active, not recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Puerta del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Active, not recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Active, not recruiting |
| Hospital de Jerez de la Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Hospital Vithas Parque San Antonio Coordinator of this site? Confirm its status | Malaga | Spain | Active, not recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Quironsalud Sagrado Corazon Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Active, not recruiting |
| General Oncological Hospital Of Kifissia Agioi Anargyroi Coordinator of this site? Confirm its status | Kifissia | Greece | Active, not recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Active, not recruiting |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| St. Luke's Hospital S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Orszagos Koranyi Pulmonologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Active, not recruiting |
| Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Szekesfehervar | Hungary | Active, not recruiting |
| Református Pulmonológiai Centrum Coordinator of this site? Confirm its status | Törökbálint | Hungary | Active, not recruiting |
| Rigas Austrumu kliniska universitates slimnica SIA Coordinator of this site? Confirm its status | Riga | Latvia | Active, not recruiting |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Active, not recruiting |
| Ziekenhuis St Jansdal Coordinator of this site? Confirm its status | Harderwijk | Netherlands | Active, not recruiting |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Med Polonia Sp z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Mazowiecki Szpital Onkologiczny Sp. z o.o. Coordinator of this site? Confirm its status | Wieliszew | Poland | Active, not recruiting |
| Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| OPN-Glendale Coordinator of this site? Confirm its status | Arcadia | United States | Unknown status |
| Health Partners Coordinator of this site? Confirm its status | Bloomington | United States | Unknown status |
| Gabrail Cancer Center Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Cleveland Clinic Mercy Hospital Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Pontchartrain Cancer Center Coordinator of this site? Confirm its status | Covington | United States | Unknown status |
| New York City Health+HospitalsCorporation Elmhurst Hospital Center Coordinator of this site? Confirm its status | Elmhurst | United States | Unknown status |
| Innova Schar Cancer Insitute Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Kansas University Mediacal Center Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| The Center for Cancer and Blood Disorders Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Lutheran Medical Center - Cancer Centers of Colorado Coordinator of this site? Confirm its status | Golden | United States | Unknown status |
| Millennium Research & Clinical Development Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Cancer Specialists of North Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Pro Research Tools, INC DBA Lumi Research Coordinator of this site? Confirm its status | Kingwood | United States | Unknown status |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| OPN-Los Alamitos Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| Southern California Permanente Group Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Tricounty Hematology and Oncology Associates Coordinator of this site? Confirm its status | Massillon | United States | Unknown status |
| Tulane University Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Eastern Connecticut Hematology & Oncology Associates Coordinator of this site? Confirm its status | Norwich | United States | Unknown status |
| Mid Florida Hematology and oncology Center Coordinator of this site? Confirm its status | Orange City | United States | Unknown status |
| Advent Health Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Napa Research Coordinator of this site? Confirm its status | Pompano Beach | United States | Unknown status |
| Kaiser Permanente Northwest Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | Queens | United States | Unknown status |
| Emad Ibrahim, MD, Inc. Coordinator of this site? Confirm its status | Redlands | United States | Unknown status |
| Renown Health Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Providence Medical Foundation Coordinator of this site? Confirm its status | Santa Rosa | United States | Unknown status |
| Northwest Medical Specialties Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| The University of Texas - Hope Cancer Center Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.