Back to resultsA 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
Primary Purpose
Limited-Stage Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Serplulimab
carboplatin/cisplatin-etoposide
Thoracic radiotherapy
Placebo
Prophylactic Cranial Irradiation (PCI)
Sponsored by
About this trial
This is an interventional treatment trial for Limited-Stage Small Cell Lung Cancer focused on measuring Limited-Stage Small Cell Lung Cancer, Serplulimab
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- OPN-GlendaleRecruiting
- OPN-Los AlamitosRecruiting
- Southern California Permanente GroupRecruiting
- Emad Ibrahim, MD, IncRecruiting
- Providence Medical FoundationRecruiting
- Lutheran Medical Center - Cancer Centers of Colorado
- Eastern Connecticut Hematology & Oncology AssociatesRecruiting
- Cancer Specialists of North FloridaRecruiting
- Mid Florida Hematology and Oncology CenterRecruiting
- Advent Health OrlandoRecruiting
- Napa Research
- Kansas University Mediacal Center
- Pontchartrain Cancer CenterRecruiting
- Tulane UniversityRecruiting
- Health PartnersRecruiting
- Renown HealthRecruiting
- Dartmouth Hitchcock Medical CenterRecruiting
- Montefiore Medical CenterRecruiting
- New York City Health+HospitalsCorporation Elmhurst Hospital Center
- Northwell Health
- Cleveland Clinic Mercy HospitalRecruiting
- Gabrail Cancer Center
- Tricounty Hematology and Oncology AssociatesRecruiting
- Kaiser Permanente NorthwestRecruiting
- The Center for Cancer and Blood DisordersRecruiting
- Millennium Research & Clinical DevelopmentRecruiting
- Pro Research Tools, INC DBA Lumi ResearchRecruiting
- The University of Texas - Hope Cancer CenterRecruiting
- Innova Schar Cancer Insitute
- Northwest Medical SpecialtiesRecruiting
- Klinikum Klagenfurt am Worthersee
- Klinikum Klagenfurt am Wörthersee
- Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie
- Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology
- The First Affiliated Hospital of Bengbu Medical College
- Anhui Chest Hospital
- Cancer Hospital Chinese Academy of Medical Sciences
- Beijing Cancer Hospital
- The First Affiliated Hospital of Chongqing Medical
- Chongqing University Cancer Hospital
- Fujian Cancer Hospital
- The First Affiliated Hospital of Guangdong Pharmaceutical University
- Sun Yat-Sen University Cancer Center
- Peking University Shenzhen Hospital
- The Second Affiliated Hospital of Guilin Medical University
- Guangxi Medical University Cancer Hospital
- Gungzhouyikedaxuefushuzhongliuyiyuan
- Affiliated Hospital of Hebei University
- Cangzhou People's Hospital
- Tangshan People's Hospital
- Harbin Medical University Cancer Hospital
- Jiamusi Cancer Hospital
- The First Affiliated Hospital of Henan University of Science and Technology
- The First Affiliated Hospital of Xinxiang Medical University
- Henan Cancer Hospital
- The First Affiliated Hospital of Zhengzhou University
- Hong Kong United Oncology CentreRecruiting
- Queen Elizabeth HospitalRecruiting
- Queen Mary HospitalRecruiting
- TaiHe Hospital Affiliated Hospital of Hubei University of Medicine
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
- Zhongnan hospital of wuhan university
- Hubei Cancer Hospital
- The First People's Hospital Of Changde City
- The Second Xiangya Hospita
- Hunan Cancer Hospital
- Xiangya Hospital Central South University
- Xuzhou Central Hospital
- Northern Jiangsu people's Hospital
- First Affiliated Hospital of Gannan Medical University
- Ganzhou Cancer Hospital
- The First Affiliated Hospital of Nanchang University
- Jilin Cancer Hospital
- Liaoning Cancer Hospital & Institute
- Shenyang The Tenth People's Hospital
- Qilu Hospital of Shandong University
- Shandong Cancer Hospital
- Linyi Tumor Hospital
- Affiliated Hospital of Qingdao University
- Shanghai Chest Hospital
- Fudan University Shanghai Cancer Center
- Zhongshan Hospital of Fudan University
- Wenzhou University Hospital
- Baoji Central Hospital
- Shanxi Provincial Cancer Hospital
- First Affiliated Hospital of Xi'an Jiaotong University
- West China Hospital of Sichuan University
- Tianjin Medical University Cancer Institute & Hospital
- Tianjin Medical University General Hospital
- The Second People's Hospital Of Yibin
- Yunnan Cancer Hospital
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
- Yuhang Branch of the First Affiliated Hospital of Zhejiang University
- Zhejiang Cancer Hospital
- The Second Affiliated Hospital Zhejiang University School of Medicine
- Taizhou Hospital of Zhejiang Province
- The 1st Affiliated Hospital of WMU
- University Hospital Brno (Clinic For Lung Diseases and Tuberculosis)
- University Hospital Brno
- University Hospital Olomouc (Oncology Clinic)
- University Hospital Ostrava (oncology department)
- University Hospital Ostrava
- Nemocnice AGEL Ostrava-Vítkovice
- Nemocnice AGEL Ostrava-Vítkovice
- University Hospital Motol
- University Hospital Motol (Pneumology Clinic 2.LF UK and FN Motol)
- General University hospital in Prague (Oncology department)
- Kliniken der Stadt Cologne GmbH
- University hospital Schleswig-Holstein
- "Sotiria" Thoracic Diseases General Hospital of Athens
- General Hospital of Athens "Alexandra"
- Fejer County Szent Gyorgy University Teaching Hospital
- Pulmonary Institute of Torokbalint
- Riga East University Hospital, Latvian Oncology Center
- Clinic of Oncology, Pauls Stradins Clinical university hospital
- Hospital St. Jansdal
- Isala Hospital
- MedPoloniaSp. z o.o.
- Lung and Chest Cancer Clinic, National Institute of Oncology
- Hospital German Trias i Pujol/ ICO Badalona
- University Hospital La Fe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy
placebo + carboplatin/cisplatin-etoposide + radiotherapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Overall survival(OS
the time from randomization to death due to any cause
Secondary Outcome Measures
Progression-free survival
PFS, assessed by the investigator as per RECIST v1.1
Full Information
NCT ID
NCT05353257
First Posted
April 25, 2022
Last Updated
October 8, 2023
Sponsor
Shanghai Henlius Biotech
1. Study Identification
Unique Protocol Identification Number
NCT05353257
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limited-Stage Small Cell Lung Cancer
Keywords
Limited-Stage Small Cell Lung Cancer, Serplulimab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
482 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo + carboplatin/cisplatin-etoposide + radiotherapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Serplulimab
Intervention Description
Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
300mg Q3W
Intervention Type
Drug
Intervention Name(s)
carboplatin/cisplatin-etoposide
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Thoracic radiotherapy
Intervention Description
Standard Thoracic Radiotherapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Q3W
Intervention Type
Radiation
Intervention Name(s)
Prophylactic Cranial Irradiation (PCI)
Intervention Description
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
Primary Outcome Measure Information:
Title
Overall survival(OS
Description
the time from randomization to death due to any cause
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
PFS, assessed by the investigator as per RECIST v1.1
Time Frame
up to approximately 24months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinming Yu, MD
Phone
138064066293
Email
sdyujinming@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Cheng
Phone
0431-80596315
Email
jl.cheng@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinming Yu, MD
Organizational Affiliation
Shandong Cancer Hospital & Institute-department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ying Cheng
Organizational Affiliation
Jilin Provincial Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
OPN-Glendale
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Lam
Phone
818-254-2526
Facility Name
OPN-Los Alamitos
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vu Phan
Phone
818-254-2526
Facility Name
Southern California Permanente Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric McGary
Phone
626-261-2864
Facility Name
Emad Ibrahim, MD, Inc
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emad Ibrahim
Phone
909-793-4336
Facility Name
Providence Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iran Anderson
Phone
707-521-3814
Facility Name
Lutheran Medical Center - Cancer Centers of Colorado
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karng Log
Phone
303-403-7333
Facility Name
Eastern Connecticut Hematology & Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Slater
Phone
860-866-8362
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehdi Moezi
Phone
904-538-4488
Facility Name
Mid Florida Hematology and Oncology Center
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santosh Nair
Phone
386-538-3169
Facility Name
Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarek Mekhail
Phone
407-303-2024
Facility Name
Napa Research
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kahn
Phone
954-773-9890
Facility Name
Kansas University Mediacal Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Huang
Phone
913-588-2459
Facility Name
Pontchartrain Cancer Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Oubre
Phone
985-419-0025
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Sides
Phone
504-988-6770
Facility Name
Health Partners
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Ji
Phone
952-993-1555
Facility Name
Renown Health
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Thomas
Phone
775-982-3684
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geregory Russo
Phone
603-653-9052
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitin Ohri
Phone
952-993-1555
Facility Name
New York City Health+HospitalsCorporation Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Perwaiz
Phone
844-692-4692
Facility Name
Northwell Health
City
Queens
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nagashree Seetharamu
Phone
516-734-8900
Facility Name
Cleveland Clinic Mercy Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Haut
Phone
330-489-1274
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashat Gabrail
Phone
330-492-3345
Facility Name
Tricounty Hematology and Oncology Associates
City
Massillon
State/Province
Ohio
ZIP/Postal Code
44646
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nagaprasad Nagajothi
Phone
330-489-1274
Facility Name
Kaiser Permanente Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandeep Mashru
Phone
503-331-2500
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ray Page
Phone
817-759-7023
Facility Name
Millennium Research & Clinical Development
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murtuza Bhuriwala
Phone
832-330-5090
Facility Name
Pro Research Tools, INC DBA Lumi Research
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saleha Sajid
Phone
832-615-6090
Facility Name
The University of Texas - Hope Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arielle Lee
Phone
903-592-6152
Facility Name
Innova Schar Cancer Insitute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janaki Subramanian
Phone
571-999-7271
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Veatch
Phone
233-380-5999
Facility Name
Klinikum Klagenfurt am Worthersee
City
Klagenfurt am Worthersee
ZIP/Postal Code
9020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Rauter
Phone
+43 463 538 313 03
Facility Name
Klinikum Klagenfurt am Wörthersee
City
Klagenfurt am Wörthersee
ZIP/Postal Code
9020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Rauter
Facility Name
Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie
City
Wien
ZIP/Postal Code
1210
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maximilian Hochmair
Facility Name
Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology
City
Wien
ZIP/Postal Code
1210
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maximilian Hochmair
Phone
+43 1 277 700 722 12
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233099
Country
China
Individual Site Status
Completed
Facility Name
Anhui Chest Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Individual Site Status
Completed
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Completed
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Completed
Facility Name
The First Affiliated Hospital of Chongqing Medical
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Completed
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Completed
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350011
Country
China
Individual Site Status
Completed
Facility Name
The First Affiliated Hospital of Guangdong Pharmaceutical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Completed
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510030
Country
China
Individual Site Status
Completed
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Completed
Facility Name
The Second Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541100
Country
China
Individual Site Status
Completed
Facility Name
Guangxi Medical University Cancer Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Completed
Facility Name
Gungzhouyikedaxuefushuzhongliuyiyuan
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510095
Country
China
Individual Site Status
Completed
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Individual Site Status
Completed
Facility Name
Cangzhou People's Hospital
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
061019
Country
China
Individual Site Status
Completed
Facility Name
Tangshan People's Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063001
Country
China
Individual Site Status
Completed
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Completed
Facility Name
Jiamusi Cancer Hospital
City
Jiamusi
State/Province
Heilongjiang
ZIP/Postal Code
154007
Country
China
Individual Site Status
Completed
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Individual Site Status
Completed
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453100
Country
China
Individual Site Status
Completed
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Completed
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Completed
Facility Name
Hong Kong United Oncology Centre
City
Hong kong
State/Province
Hong Kong
ZIP/Postal Code
999077
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacky Li
Phone
23868003
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
999077
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Tin Yan
Phone
52782641
Facility Name
Queen Mary Hospital
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
999077
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Leung
Phone
22555102
Facility Name
TaiHe Hospital Affiliated Hospital of Hubei University of Medicine
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
Individual Site Status
Completed
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Completed
Facility Name
Zhongnan hospital of wuhan university
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Completed
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First People's Hospital Of Changde City
City
Changde
State/Province
Hunan
ZIP/Postal Code
415000
Country
China
Individual Site Status
Completed
Facility Name
The Second Xiangya Hospita
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Completed
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Completed
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Completed
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Completed
Facility Name
Northern Jiangsu people's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Completed
Facility Name
First Affiliated Hospital of Gannan Medical University
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
341001
Country
China
Individual Site Status
Completed
Facility Name
Ganzhou Cancer Hospital
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
341005
Country
China
Individual Site Status
Completed
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Completed
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Completed
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liao Ning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Completed
Facility Name
Shenyang The Tenth People's Hospital
City
Shenyang
State/Province
Liao Ning
ZIP/Postal Code
110044
Country
China
Individual Site Status
Completed
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Completed
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Completed
Facility Name
Linyi Tumor Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276002
Country
China
Individual Site Status
Completed
Facility Name
Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266031
Country
China
Individual Site Status
Completed
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Completed
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Completed
Facility Name
Zhongshan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Completed
Facility Name
Wenzhou University Hospital
City
Wenzhou
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Completed
Facility Name
Baoji Central Hospital
City
Baoji
State/Province
Shanxi
ZIP/Postal Code
721008
Country
China
Individual Site Status
Completed
Facility Name
Shanxi Provincial Cancer Hospital
City
TaiYuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Individual Site Status
Completed
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Completed
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Completed
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Completed
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Completed
Facility Name
The Second People's Hospital Of Yibin
City
Sichuan
State/Province
Yibin
ZIP/Postal Code
644000
Country
China
Individual Site Status
Completed
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Individual Site Status
Completed
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Completed
Facility Name
Yuhang Branch of the First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Completed
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Individual Site Status
Completed
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Completed
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Completed
Facility Name
The 1st Affiliated Hospital of WMU
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Completed
Facility Name
University Hospital Brno (Clinic For Lung Diseases and Tuberculosis)
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristian Brat
Phone
+420 775 747 176
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristian Brat
Facility Name
University Hospital Olomouc (Oncology Clinic)
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bohuslav Melichar
Phone
+420 588 444 288
Facility Name
University Hospital Ostrava (oncology department)
City
Ostrava-Poruba
ZIP/Postal Code
570852
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamila Resova
Phone
+420 597 372 123
Facility Name
University Hospital Ostrava
City
Ostrava-Poruba
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamila Resova
Facility Name
Nemocnice AGEL Ostrava-Vítkovice
City
Ostrava-Vitkovice
ZIP/Postal Code
703 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaromir Roubec
Phone
+420 603 500 637
Facility Name
Nemocnice AGEL Ostrava-Vítkovice
City
Ostrava-Vítkovice
ZIP/Postal Code
703 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaromir Roubec
Facility Name
University Hospital Motol
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leona Koubkova
Facility Name
University Hospital Motol (Pneumology Clinic 2.LF UK and FN Motol)
City
Prague
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leona Koubkova
Phone
+420 224 436 644
Facility Name
General University hospital in Prague (Oncology department)
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milada Zemanova
Phone
+420 224 966 405
Facility Name
Kliniken der Stadt Cologne GmbH
City
Cologne
ZIP/Postal Code
51109
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Lotte Buchmeier
Phone
+49 221 8907 3250
Facility Name
University hospital Schleswig-Holstein
City
Lübeck-Travemünde
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Bohnet
Phone
+49 451 500 430 45
Facility Name
"Sotiria" Thoracic Diseases General Hospital of Athens
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Syrigos
Phone
+30 6945210150
Facility Name
General Hospital of Athens "Alexandra"
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flora Zagouri
Phone
+306946462998
Facility Name
Fejer County Szent Gyorgy University Teaching Hospital
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsolt Pápai Székely
Phone
+36 30 253 8757
Facility Name
Pulmonary Institute of Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella Gálffy
Phone
+36 30 951 3053
Facility Name
Riga East University Hospital, Latvian Oncology Center
City
Riga
ZIP/Postal Code
LV 1079
Country
Latvia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zanete Zvirbule
Phone
+371 29536734
Facility Name
Clinic of Oncology, Pauls Stradins Clinical university hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aija Gerina Berzina
Phone
+ 371 670 694 57
Facility Name
Hospital St. Jansdal
City
Harderwijk
ZIP/Postal Code
3844
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisenka Boom
Phone
+31 341 464 743
Facility Name
Isala Hospital
City
Zwolle
ZIP/Postal Code
8025
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Adrianus Stigt
Phone
+31 38 424 2456
Facility Name
MedPoloniaSp. z o.o.
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodryg Ramlau
Phone
+48 501 296 922
Facility Name
Lung and Chest Cancer Clinic, National Institute of Oncology
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Olszyna Serementa
Phone
+48 604 491 696
Facility Name
Hospital German Trias i Pujol/ ICO Badalona
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enric Carcereny
Phone
+34 34934978925
Facility Name
University Hospital La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Jose Juan Vidal
Phone
+34 961245872
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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