Clinical trial NCT05353257: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Limited-Stage Small Cell Lung Cancer
Keywords: Limited-Stage Small Cell Lung Cancer
Serplulimab
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival(OS
timeFrame: up to 36 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: up to approximately 24months
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: OPN-Glendale
state: California
city: Los Alamitos
country: United States
facility: OPN-Los Alamitos
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Group
state: California
city: Redlands
country: United States
facility: Emad Ibrahim, MD, Inc
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Foundation
state: California
city: Golden
country: United States
facility: Lutheran Medical Center - Cancer Centers of Colorado
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology & Oncology Associates
state: Connecticut
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Pompano Beach
country: United States
facility: Napa Research
state: Florida
city: Fairway
country: United States
facility: Kansas University Mediacal Center
state: Kansas
city: Covington
country: United States
facility: Pontchartrain Cancer Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Bloomington
country: United States
facility: Health Partners
state: Minnesota
city: Reno
country: United States
facility: Renown Health
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Elmhurst
country: United States
facility: New York City Health+HospitalsCorporation Elmhurst Hospital Center
state: New York
city: Queens
country: United States
facility: Northwell Health
state: New York
city: Canton
country: United States
facility: Cleveland Clinic Mercy Hospital
state: Ohio
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Massillon
country: United States
facility: Tricounty Hematology and Oncology Associates
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Millennium Research & Clinical Development
state: Texas
city: Kingwood
country: United States
facility: Pro Research Tools, INC DBA Lumi Research
state: Texas
city: Tyler
country: United States
facility: The University of Texas - Hope Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Innova Schar Cancer Insitute
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Klagenfurt am Worthersee
country: Austria
facility: Klinikum Klagenfurt am Worthersee
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Wien
country: Austria
facility: Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie
city: Wien
country: Austria
facility: Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Anhui Chest Hospital
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical
state: Chongqing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangdong Pharmaceutical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Guilin
country: China
facility: The Second Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Guangzhou
country: China
facility: Gungzhouyikedaxuefushuzhongliuyiyuan
state: Guangzhou
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
state: Hebei
city: Tangshan
country: China
facility: Tangshan People's Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Jiamusi
country: China
facility: Jiamusi Cancer Hospital
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Hong kong
country: China
facility: Hong Kong United Oncology Centre
state: Hong Kong
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
state: Hong Kong
city: Hong Kong
country: China
facility: Queen Mary Hospital
state: Hong Kong
city: Shiyan
country: China
facility: TaiHe Hospital Affiliated Hospital of Hubei University of Medicine
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Zhongnan hospital of wuhan university
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changde
country: China
facility: The First People's Hospital Of Changde City
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospita
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu people's Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
state: Jiangxi
city: Ganzhou
country: China
facility: Ganzhou Cancer Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liao Ning
city: Shenyang
country: China
facility: Shenyang The Tenth People's Hospital
state: Liao Ning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi Tumor Hospital
state: Shandong
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
city: Wenzhou
country: China
facility: Wenzhou University Hospital
state: Shanghai
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shanxi
city: TaiYuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Sichuan
country: China
facility: The Second People's Hospital Of Yibin
state: Yibin
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Yuhang Branch of the First Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Wenzhou
country: China
facility: The 1st Affiliated Hospital of WMU
state: Zhejiang
city: Brno
country: Czechia
facility: University Hospital Brno (Clinic For Lung Diseases and Tuberculosis)
city: Brno
country: Czechia
facility: University Hospital Brno
city: Olomouc
country: Czechia
facility: University Hospital Olomouc (Oncology Clinic)
city: Ostrava-Poruba
country: Czechia
facility: University Hospital Ostrava (oncology department)
city: Ostrava-Poruba
country: Czechia
facility: University Hospital Ostrava
city: Ostrava-Vitkovice
country: Czechia
facility: Nemocnice AGEL Ostrava-Vítkovice
city: Ostrava-Vítkovice
country: Czechia
facility: Nemocnice AGEL Ostrava-Vítkovice
city: Prague
country: Czechia
facility: University Hospital Motol
city: Prague
country: Czechia
facility: University Hospital Motol (Pneumology Clinic 2.LF UK and FN Motol)
city: Praha 2
country: Czechia
facility: General University hospital in Prague (Oncology department)
city: Cologne
country: Germany
facility: Kliniken der Stadt Cologne GmbH
city: Lübeck-Travemünde
country: Germany
facility: University hospital Schleswig-Holstein
city: Athens
country: Greece
facility: "Sotiria" Thoracic Diseases General Hospital of Athens
city: Athens
country: Greece
facility: General Hospital of Athens "Alexandra"
city: Szekesfehervar
country: Hungary
facility: Fejer County Szent Gyorgy University Teaching Hospital
city: Torokbalint
country: Hungary
facility: Pulmonary Institute of Torokbalint
city: Riga
country: Latvia
facility: Riga East University Hospital, Latvian Oncology Center
city: Riga
country: Latvia
facility: Clinic of Oncology, Pauls Stradins Clinical university hospital
city: Harderwijk
country: Netherlands
facility: Hospital St. Jansdal
city: Zwolle
country: Netherlands
facility: Isala Hospital
city: Poznan
country: Poland
facility: MedPoloniaSp. z o.o.
city: Warszawa
country: Poland
facility: Lung and Chest Cancer Clinic, National Institute of Oncology
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Badalona
country: Spain
facility: Hospital German Trias i Pujol/ ICO Badalona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Sevilla
country: Spain
facility: Hospital Quironsalud Sagrado Corazón
city: Valdecilla
country: Spain
facility: Hospital Marques de Valdecilla
city: Valencia
country: Spain
facility: University Hospital La Fe
Study officials:
affiliation: Shandong Cancer Hospital & Institute-department
name: Jinming Yu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jilin Provincial Tumor Hospital
name: Ying Cheng
role: PRINCIPAL_INVESTIGATOR
References: