To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
NCT ID: NCT05468489
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2022-11-18
2027-12-31
Brief Summary
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Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows:
* Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide)
* Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Serplulimab + chemotherapy
Serplulimab + chemotherapy (carboplatin-etoposide)
Serplulimab + chemotherapy (carboplatin-etoposide)
Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
Drug: carboplatin and etoposide chemotherapeutics
Atezolizumab + chemotherapy
Atezolizumab + chemotherapy (carboplatin-etoposide)
Atezolizumab + chemotherapy (carboplatin-etoposide)
Drug: Atezolizumab is a monoclonal antibody targeting PD-L1，developed by Roche Pharma AG.
Drug: carboplatin and etoposide chemotherapeutics
Interventions
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Serplulimab + chemotherapy (carboplatin-etoposide)
Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
Drug: carboplatin and etoposide chemotherapeutics
Atezolizumab + chemotherapy (carboplatin-etoposide)
Drug: Atezolizumab is a monoclonal antibody targeting PD-L1，developed by Roche Pharma AG.
Drug: carboplatin and etoposide chemotherapeutics
Eligibility Criteria
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Inclusion Criteria
Male or female aged ≥ 18 years at the time of signing the ICF.
Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
No prior systemic therapy for ES-SCLC.
At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization.
Major organs are functioning well.
Every effort should be made to provide tumor tissues for the determination of PD-L1 expression.
An ECOG PS score of 0 or 1.
An expected survival ≥ 12 weeks.
Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment.
Participant must keep contraception.
Exclusion Criteria
Known history of severe allergy to any monoclonal antibody.
Known hypersensitivity to carboplatin or etoposide.
Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia.
Pregnant or breastfeeding females.
Patients with a known history of psychotropic drug abuse or drug addiction.
Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.
18 Years
ALL
No
Sponsors
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Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Locations
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Alabama Oncology
Birmingham, Alabama, United States
City of Hope - Phoenix
Goodyear, Arizona, United States
Arizona Clinical Research Center (ACRC)
Tucson, Arizona, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Compassionate Care Research Group
Fountain Valley, California, United States
Providence Medical Foundation
Fullerton, California, United States
Los Angeles Cancer Network
Glendale, California, United States
OPN - Oncology Physician Network
Los Alamitos, California, United States
Kaiser Permanente Research (Southern California)
Los Angeles, California, United States
UC Davis
Sacramento, California, United States
UCHealth Memorial Hospital North
Colorado Springs, Colorado, United States
Banner MD Anderson Cancer Center (BMDACC)
Greeley, Colorado, United States
MD Anderson- North Colorado Medical Center
Greeley, Colorado, United States
Advanced Cancer Treatment Centers
Brooksville, Florida, United States
Cancer Specialists North Florida
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, United States
Florida Cancer Affiliates- (Ocala Oncology - Main)
Ocala, Florida, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
BRCR Global
Plantation, Florida, United States
Napa Research
Pompano Beach, Florida, United States
Advanced Research
Tamarac, Florida, United States
City of Hope- Chicago
Chicago, Illinois, United States
Cancer Center of Decatur
Decatur, Illinois, United States
Accellacare of Duly
Tinley Park, Illinois, United States
Northwest Cancer Centers
Dyer, Indiana, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Pikeville Hospital
Pikeville, Kentucky, United States
CHRISTUS St. Frances Cabrini Cancer Center
Alexandria, Louisiana, United States
Pontchartrain Cancer Center
Hammond, Louisiana, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, United States
Health Partners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
North Mississippi Medical Center Hematology and Oncology Clinic
Tupelo, Mississippi, United States
MidAmerica Division Inc., c/o Research Medical Center
Kansas City, Missouri, United States
Lake Regional
Osage Beach, Missouri, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Renown Health
Reno, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Regional Cancer Care Associates LLC RCCA
Freehold, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Elmhurst (BRANY site)
Elmhurst, New York, United States
Northwell Health
Lake Success, New York, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
Great Lakes Cancer Care (Kaleida Health)
Williamsville, New York, United States
Summa Health
Akron, Ohio, United States
Cleveland Clinic Mercy Hospital
Canton, Ohio, United States
Aultman Cancer Center
Canton, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Tricounty Hematology and Oncology Associates
Massillon, Ohio, United States
CharterCARE (Roger Williams)
Providence, Rhode Island, United States
Monument Health
Rapid City, South Dakota, United States
CHRISTUS Institute for Innovation & Advanced Clinical Care
Corpus Christi, Texas, United States
DHR Research
Edinburg, Texas, United States
Millennium Research and Clinical Development
Houston, Texas, United States
Lumi Research
Kingwood, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
The University of Texas Health Science Center at Tyler/HOPE Cancer Center
Tyler, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
American Oncology Network Vista Oncology Division
Olympia, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Froedtert Hospital- Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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ASTRIDE (HLX10-005-SCLC301-E)
Identifier Type: -
Identifier Source: org_study_id
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