A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)

Status: Recruiting
Location: See all (99) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Alabama Oncology
RECRUITING
Birmingham
O'Neal Comprehensive Cancer Center
WITHDRAWN
Birmingham
Arkansas
Highlands Oncology Group
RECRUITING
Springdale
Arizona
City of Hope - Phoenix
RECRUITING
Goodyear
Arizona Clinical Research Center (ACRC)
RECRUITING
Tucson
California
OPN - Oncology Physician Network
WITHDRAWN
Arcadia
Compassionate Care Research Group
RECRUITING
Fountain Valley
Providence Medical Foundation
RECRUITING
Fullerton
Los Angeles Cancer Network
RECRUITING
Glendale
Long Beach Memorial Medical Center
WITHDRAWN
Long Beach
OPN - Oncology Physician Network
RECRUITING
Los Alamitos
California Research Institute
WITHDRAWN
Los Angeles
Kaiser Permanente Research (Southern California)
RECRUITING
Los Angeles
UC Davis
RECRUITING
Sacramento
Providence Medical Group
WITHDRAWN
Santa Rosa
Colorado
UCHealth Memorial Hospital North
RECRUITING
Colorado Springs
Saint Joseph Hospital
WITHDRAWN
Denver
Lutheran Medical Cancer Center
WITHDRAWN
Golden
Banner MD Anderson Cancer Center (BMDACC)
RECRUITING
Greeley
MD Anderson- North Colorado Medical Center
RECRUITING
Greeley
Connecticut
Eastern Connecticut Hematology and Oncology Associates
WITHDRAWN
Norwich
The Stamford Hospital
WITHDRAWN
Stamford
Florida
Advanced Cancer Treatment Centers
RECRUITING
Brooksville
Clermont Oncology Center
RECRUITING
Clermont
Cancer Specialists North Florida
RECRUITING
Jacksonville
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami
United Medical Group
WITHDRAWN
Miami
Florida Cancer Affiliates- (Ocala Oncology - Main)
RECRUITING
Ocala
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
BRCR Global
RECRUITING
Plantation
Napa Research
RECRUITING
Pompano Beach
Advanced Research
RECRUITING
Tamarac
Illinois
City of Hope- Chicago
RECRUITING
Chicago
Cancer Center of Decatur
RECRUITING
Decatur
NorthShore University Health System
WITHDRAWN
Evanston
Northwest Oncology and Hematology
WITHDRAWN
Rolling Meadows
Accellacare of Duly
RECRUITING
Tinley Park
Indiana
Northwest Cancer Centers
RECRUITING
Dyer
Kansas
Cancer Center of Kansas
RECRUITING
Wichita
Kentucky
Baptist Health Lexington
RECRUITING
Lexington
Norton Healthcare - Norton Cancer Institute - Downtown Women's Cancer Center
WITHDRAWN
Louisville
Pikeville Hospital
RECRUITING
Pikeville
Louisiana
CHRISTUS St. Frances Cabrini Cancer Center
RECRUITING
Alexandria
Pontchartrain Cancer Center
RECRUITING
Covington
Pontchartrain Cancer Center
RECRUITING
Hammond
Tulane Medical Center
WITHDRAWN
New Orleans
Willis-Knighton Cancer Center
WITHDRAWN
Shreveport
Massachusetts
Tufts Medicine
WITHDRAWN
Boston
Lahey Hospital & Medical Center
RECRUITING
Burlington
Maryland
Sandra and Malcolm Berman Cancer Institute at Greater Baltimore Medical Center
WITHDRAWN
Baltimore
American Oncology Partners of Maryland, PA
WITHDRAWN
Bethesda
Michigan
Henry Ford Health Providence Southfield Hospital
RECRUITING
Southfield
Minnesota
Health Partners Cancer Center at Regions Hospital
RECRUITING
Saint Paul
Missouri
MidAmerica Division Inc., c/o Research Medical Center
RECRUITING
Kansas City
Saint Luke's Hospital Cancer Institute
WITHDRAWN
Kansas City
Lake Regional
RECRUITING
Osage Beach
Oncology Hematology Associates
WITHDRAWN
Springfield
Mississippi
Hattiesburg Clinic Hematology/Oncology
RECRUITING
Hattiesburg
North Mississippi Medical Center Hematology and Oncology Clinic
RECRUITING
Tupelo
Montana
St. Vincent Frontier Cancer Center
RECRUITING
Billings
Nebraska
Cancer Partners of Nebraska
WITHDRAWN
Lincoln
Nebraska Methodist Hospital
WITHDRAWN
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
Summit Medical Group
WITHDRAWN
Florham Park
Regional Cancer Care Associates LLC RCCA
RECRUITING
Freehold
Jersey Shore University Medical Center
RECRUITING
Neptune City
New Mexico
CHRISTUS St. Vincent
WITHDRAWN
Santa Fe
Nevada
Renown Health
RECRUITING
Reno
New York
Elmhurst (BRANY site)
RECRUITING
Elmhurst
Northwell Health
RECRUITING
Lake Success
Stony Brook Cancer Center
RECRUITING
Stony Brook
Great Lakes Cancer Care (Kaleida Health)
RECRUITING
Williamsville
Ohio
Summa Health
RECRUITING
Akron
Aultman Cancer Center
RECRUITING
Canton
Cleveland Clinic Mercy Hospital
RECRUITING
Canton
Gabrail Cancer Center (GCC) Research- Canton Facility
RECRUITING
Canton
MetroHealth
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Tricounty Hematology and Oncology Associates
RECRUITING
Massillon
The Toledo Clinic
WITHDRAWN
Toledo
Rhode Island
CharterCARE (Roger Williams)
RECRUITING
Providence
South Dakota
Monument Health
RECRUITING
Rapid City
Texas
CHRISTUS Institute for Innovation & Advanced Clinical Care
RECRUITING
Corpus Christi
DHR Research
RECRUITING
Edinburg
The Center for Cancer and Blood Disorders
WITHDRAWN
Fort Worth
Valley Cancer Associates
WITHDRAWN
Harlingen
Millennium Research and Clinical Development
RECRUITING
Houston
Lumi Research
RECRUITING
Kingwood
Joe Arrington Cancer Research and Treatment Center
RECRUITING
Lubbock
The University of Texas Health Science Center at Tyler/HOPE Cancer Center
RECRUITING
Tyler
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Utah Cancer Specialists
RECRUITING
Salt Lake City
Washington
American Oncology Network Vista Oncology Division
RECRUITING
Olympia
Medical Oncology Associates, PS (dba Summit Cancer Centers)
RECRUITING
Spokane Valley
Northwest Medical Specialties, PLLC
RECRUITING
Tacoma
Wisconsin
University of Wisconsin Carbone Cancer Center
RECRUITING
Madison
Froedtert Hospital- Medical College of Wisconsin
RECRUITING
Milwaukee
West Virginia
West Virginia University Cancer Institute
RECRUITING
Morgantown
Contact Information
Primary
Nikki James
nikki_james@henlius.com
+1404-957-8687
Time Frame
Start Date: 2022-11-18
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Serplulimab + chemotherapy
Serplulimab + chemotherapy (carboplatin-etoposide)
Active_comparator: Atezolizumab + chemotherapy
Atezolizumab + chemotherapy (carboplatin-etoposide)
Sponsors
Leads: Shanghai Henlius Biotech

This content was sourced from clinicaltrials.gov

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