To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Shanghai Henlius Biotech
Study ID
NCT05468489
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Nov 18, 2022
Status verified
Oct 2025
Primary completion
Feb 28, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Serplulimab + chemotherapy
    Serplulimab + chemotherapy (carboplatin-etoposide)
  • Active Comparator: Atezolizumab + chemotherapy
    Atezolizumab + chemotherapy (carboplatin-etoposide)

Primary Outcome Measure

OS [ Time Frame: A period from randomization through death regardless of causality (approximately up to 24 months). ]

Locations (67)

FacilityCityStateZIPSite coordinators
Alabama OncologyBirminghamAlabama35223-
City of Hope - PhoenixGoodyearArizona85338-
Arizona Clinical Research Center (ACRC)TucsonArizona85715-
Highlands Oncology GroupSpringdaleArkansas72762-
Compassionate Care Research GroupFountain ValleyCalifornia92708-
Providence Medical FoundationFullertonCalifornia92835-
Los Angeles Cancer NetworkGlendaleCalifornia91204-
OPN - Oncology Physician NetworkLos AlamitosCalifornia90720-
Kaiser Permanente Research (Southern California)Los AngelesCalifornia90034-
UC DavisSacramentoCalifornia95817-
UCHealth Memorial Hospital NorthColorado SpringsColorado80920-
Banner MD Anderson Cancer Center (BMDACC)GreeleyColorado80631-
MD Anderson- North Colorado Medical CenterGreeleyColorado80631-
Advanced Cancer Treatment CentersBrooksvilleFlorida34613-
Cancer Specialists North FloridaJacksonvilleFlorida32256-
Mount Sinai Comprehensive Cancer CenterMiamiFlorida33140-
Florida Cancer Affiliates- (Ocala Oncology - Main)OcalaFlorida34473-
Mid Florida Hematology and Oncology CenterOrange CityFlorida32763-
BRCR GlobalPlantationFlorida33322-
Napa ResearchPompano BeachFlorida33064-
Advanced ResearchTamaracFlorida33321-
City of Hope- ChicagoChicagoIllinois60099-
Cancer Center of DecaturDecaturIllinois62526-
Accellacare of DulyTinley ParkIllinois60487-
Northwest Cancer CentersDyerIndiana46311-
Cancer Center of KansasWichitaKansas67214-
Baptist Health LexingtonLexingtonKentucky40503-
Pikeville HospitalPikevilleKentucky41501-
CHRISTUS St. Frances Cabrini Cancer CenterAlexandriaLouisiana71301-
Pontchartrain Cancer CenterHammondLouisiana70433-
Lahey Hospital & Medical CenterBurlingtonMassachusetts01805-
Henry Ford Health Providence Southfield HospitalSouthfieldMichigan48075-
Health Partners Cancer Center at Regions HospitalSaint PaulMinnesota55101-
Hattiesburg Clinic Hematology/OncologyHattiesburgMississippi39401-
North Mississippi Medical Center Hematology and Oncology ClinicTupeloMississippi38801-
MidAmerica Division Inc., c/o Research Medical CenterKansas CityMissouri64132-
Lake RegionalOsage BeachMissouri65065-
St. Vincent Frontier Cancer CenterBillingsMontana59102-
University of Nebraska Medical CenterOmahaNebraska68106-
Renown HealthRenoNevada89502-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Regional Cancer Care Associates LLC RCCAFreeholdNew Jersey03756-
Jersey Shore University Medical CenterNeptune CityNew Jersey07753-
Elmhurst (BRANY site)ElmhurstNew York11373-
Northwell HealthLake SuccessNew York11042-
Stony Brook Cancer CenterStony BrookNew York11794-
Great Lakes Cancer Care (Kaleida Health)WilliamsvilleNew York14221-
Summa HealthAkronOhio44304-
Aultman Cancer CenterCantonOhio44710-
Cleveland Clinic Mercy HospitalCantonOhio44708-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Tricounty Hematology and Oncology AssociatesMassillonOhio44646-
CharterCARE (Roger Williams)ProvidenceRhode Island02908-
Monument HealthRapid CitySouth Dakota57701-
CHRISTUS Institute for Innovation & Advanced Clinical CareCorpus ChristiTexas78404-
DHR ResearchEdinburgTexas78539-
Millennium Research and Clinical DevelopmentHoustonTexas77090-
Lumi ResearchKingwoodTexas77339-
Joe Arrington Cancer Research and Treatment CenterLubbockTexas79410-
The University of Texas Health Science Center at Tyler/HOPE Cancer CenterTylerTexas75701-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
American Oncology Network Vista Oncology DivisionOlympiaWashington98502-
Northwest Medical Specialties, PLLCTacomaWashington98405-
West Virginia University Cancer InstituteMorgantownWest Virginia26505-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-
Froedtert Hospital- Medical College of WisconsinMilwaukeeWisconsin53226-

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Alabama Oncology· Birmingham, ALCity of Hope - Phoenix· Goodyear, AZArizona Clinical Research Center (ACRC)· Tucson, AZHighlands Oncology Group· Springdale, ARCompassionate Care Research Group· Fountain Valley, CAProvidence Medical Foundation· Fullerton, CA

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