To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05468489
- Lead Sponsor
- Shanghai Henlius Biotech
- Brief Summary
This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC.
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Voluntary participation in clinical studies.
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.
Histologically or cytologically confirmed mixed SCLC.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Serplulimab + chemotherapy Serplulimab + chemotherapy (carboplatin-etoposide) Serplulimab + chemotherapy (carboplatin-etoposide) Atezolizumab + chemotherapy Atezolizumab + chemotherapy (carboplatin-etoposide) Atezolizumab + chemotherapy (carboplatin-etoposide)
- Primary Outcome Measures
Name Time Method OS A period from randomization through death regardless of causality (approximately up to 24 months). Overall assessment
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 approximately up to 24 months Adverse events are described and graded using the grading categories defined in CTCAE, Version 5.0
Maximum Plasma Concentration (Cmax) approximately up to 24 months The maximum concentration (Cmax) of Serplulimab will be measured
Minimum Plasma Concentration (Cmin) approximately up to 24 months The minimum concentration (Cmin) of Serplulimab will be measured
PFS approximately up to 24 months Progression-free survival
Average Plasma Concentration (Cavg) approximately up to 24 months The average Plasma Concentration (Cavg) of Serplulimab will be measured
ORR approximately up to 14 months Objective response rate
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (97)
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
O'Neal Comprehensive Cancer Center
🇺🇸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
OPN - Oncology Physician Network
🇺🇸Los Alamitos, California, 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
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
California Research Institute
🇺🇸Los Angeles, California, United States
Kaiser Permanente Research (Southern California)
🇺🇸Los Angeles, California, United States
UC Davis
🇺🇸Sacramento, California, United States
Providence Medical Group
🇺🇸Santa Rosa, California, United States
UCHealth Memorial Hospital North
🇺🇸Colorado Springs, Colorado, United States
Saint Joseph Hospital
🇺🇸Denver, Colorado, United States
Lutheran Medical Cancer Center
🇺🇸Golden, Colorado, United States
Banner MD Anderson Cancer Center (BMDACC)
🇺🇸Greeley, Colorado, United States
MD Anderson- North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
The Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Advanced Cancer Treatment Centers
🇺🇸Brooksville, Florida, United States
Clermont Oncology Center
🇺🇸Clermont, Florida, United States
Cancer Specialists North Florida
🇺🇸Jacksonville, Florida, United States
United Medical Group
🇺🇸Miami, 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
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
Northwest Oncology and Hematology
🇺🇸Rolling Meadows, 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
Norton Healthcare - Norton Cancer Institute - Downtown Women's Cancer Center
🇺🇸Louisville, 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
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
Willis-Knighton Cancer Center
🇺🇸Shreveport, Louisiana, United States
Sandra and Malcolm Berman Cancer Institute at Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
American Oncology Partners of Maryland, PA
🇺🇸Bethesda, Maryland, United States
Tufts Medicine
🇺🇸Boston, Massachusetts, 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
Saint Luke's Hospital Cancer Institute
🇺🇸Kansas City, Missouri, United States
MidAmerica Division Inc., c/o Research Medical Center
🇺🇸Kansas City, Missouri, United States
Lake Regional
🇺🇸Osage Beach, Missouri, United States
Oncology Hematology Associates
🇺🇸Springfield, Missouri, United States
St. Vincent Frontier Cancer Center
🇺🇸Billings, Montana, United States
Cancer Partners of Nebraska
🇺🇸Lincoln, Nebraska, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Renown Health
🇺🇸Reno, Nevada, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, United States
Regional Cancer Care Associates LLC RCCA
🇺🇸Freehold, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
CHRISTUS St. Vincent
🇺🇸Santa Fe, New Mexico, 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
Gabrail Cancer Center (GCC) Research- Canton Facility
🇺🇸Canton, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
MetroHealth
🇺🇸Cleveland, Ohio, United States
Tricounty Hematology and Oncology Associates
🇺🇸Massillon, Ohio, United States
The Toledo Clinic
🇺🇸Toledo, 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
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Valley Cancer Associates
🇺🇸Harlingen, 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
Medical Oncology Associates, PS (dba Summit Cancer Centers)
🇺🇸Spokane Valley, 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