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

Last updated: January 22, 2025
Sponsor: Shanghai Henlius Biotech
Overall Status: Active - Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Treatment

Serplulimab + chemotherapy (carboplatin-etoposide)

HLX10 + chemotherapy (carboplatin-etoposide)

Atezolizumab + chemotherapy (carboplatin-etoposide)

Clinical Study ID

NCT05468489
ASTRIDE (HLX10-005-SCLC301-E)
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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.

Exclusion

Exclusion Criteria:

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

Total Participants: 200
Treatment Group(s): 3
Primary Treatment: Serplulimab + chemotherapy (carboplatin-etoposide)
Phase: 3
Study Start date:
November 18, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Alabama Oncology

    Birmingham, Alabama 35223
    United States

    Active - Recruiting

  • O'Neal Comprehensive Cancer Center

    Birmingham, Alabama 352942
    United States

    Site Not Available

  • City of Hope - Phoenix

    Goodyear, Arizona 85338
    United States

    Active - Recruiting

  • Research site

    Goodyear, Arizona 85338
    United States

    Active - Recruiting

  • Arizona Clinical Research Center (ACRC)

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • Highland Spring Group

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • Research site

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • OPN - Oncology Physician Network

    Arcadia, California 91107
    United States

    Active - Recruiting

  • Research site

    Arcadia, California 91107
    United States

    Active - Recruiting

  • Compassionate Care Research Group

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Research site

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Los Angeles Cancer Network

    Glendale, California 91204
    United States

    Active - Recruiting

  • Long Beach Memorial Medical Center

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Research site

    Long Beach, California 90806
    United States

    Active - Recruiting

  • OPN - Oncology Physician Network

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • Research site

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • California Research Institute

    Los Angeles, California 90027
    United States

    Site Not Available

  • Kaiser Permanente Research (Southern California)

    Los Angeles, California 90034
    United States

    Active - Recruiting

  • Research site

    Los Angeles, California 90034
    United States

    Active - Recruiting

  • Research site

    Pasadena, California 91101
    United States

    Site Not Available

  • UC Davis

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Providence Medical Group

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Research site

    Santa Rosa, California 90027
    United States

    Active - Recruiting

  • UCHealth Memorial Hospital North

    Colorado Springs, Colorado 80920
    United States

    Active - Recruiting

  • Saint Joseph Hospital

    Denver, Colorado 80218
    United States

    Site Not Available

  • Lutheran Medical Cancer Center

    Golden, Colorado 80401
    United States

    Site Not Available

  • Research site

    Golden, Colorado 80401
    United States

    Active - Recruiting

  • Banner MD Anderson Cancer Center (BMDACC)

    Greeley, Colorado 80631
    United States

    Active - Recruiting

  • MD Anderson- North Colorado Medical Center

    Greeley, Colorado 80631
    United States

    Active - Recruiting

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut 06360
    United States

    Active - Recruiting

  • Research site

    Stamford, Connecticut 06904
    United States

    Active - Recruiting

  • The Stamford Hospital

    Stamford, Connecticut 06904
    United States

    Site Not Available

  • Advanced Cancer Treatment Centers

    Brooksville, Florida 34613
    United States

    Active - Recruiting

  • Clermont Oncology Center

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Cancer Specialists North Florida

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami, Florida 33140
    United States

    Active - Recruiting

  • Research site

    Miami, Florida 33135
    United States

    Active - Recruiting

  • United Medical Group

    Miami, Florida 33135
    United States

    Site Not Available

  • Florida Cancer Affiliates- (Ocala Oncology - Main)

    Ocala, Florida 34473
    United States

    Active - Recruiting

  • Research site

    Ocala, Florida 34473
    United States

    Active - Recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Research site

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • BRCR Global

    Plantation, Florida 33322
    United States

    Active - Recruiting

  • Research site

    Plantation, Florida 33322
    United States

    Active - Recruiting

  • Napa Research

    Pompano Beach, Florida 33064
    United States

    Active - Recruiting

  • Research site

    Pompano Beach, Florida 33064
    United States

    Active - Recruiting

  • Advanced Research

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Research site

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • City of Hope- Chicago

    Chicago, Illinois 60099
    United States

    Active - Recruiting

  • Research site

    Chicago, Illinois 60099
    United States

    Active - Recruiting

  • Cancer Center of Decatur

    Decatur, Illinois 62526
    United States

    Active - Recruiting

  • NorthShore University Health System

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Northwest Oncology and Hematology

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Accellacare of Duly

    Tinley Park, Illinois 60487
    United States

    Active - Recruiting

  • Northwest Cancer Centers

    Dyer, Indiana 46311
    United States

    Active - Recruiting

  • Cancer Center of Kansas

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • Norton Healthcare - Norton Cancer Institute - Downtown Women's Cancer Center

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Pikeville Hospital

    Pikeville, Kentucky 41501
    United States

    Active - Recruiting

  • CHRISTUS St. Frances Cabrini Cancer Center

    Alexandria, Louisiana 71301
    United States

    Active - Recruiting

  • Pontchartrain Cancer Center

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Research site

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Pontchartrain Cancer Center

    Hammond, Louisiana 70433
    United States

    Active - Recruiting

  • Research site

    Hammond, Louisiana 70433
    United States

    Active - Recruiting

  • Research site

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Tulane Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Willis-Knighton Cancer Center

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Sandra and Malcolm Berman Cancer Institute at Greater Baltimore Medical Center

    Baltimore, Maryland 21204
    United States

    Site Not Available

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Research site

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Tufts Medicine

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts 01805
    United States

    Active - Recruiting

  • Ascension Providence Hospital CK Potluri Cancer Center

    Southfield, Michigan 48075
    United States

    Active - Recruiting

  • Henry Ford Health Providence Southfield Hospital

    Southfield, Michigan 48075
    United States

    Active - Recruiting

  • Health Partners Cancer Center at Regions Hospital

    Saint Paul, Minnesota 55101
    United States

    Active - Recruiting

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi 39401
    United States

    Active - Recruiting

  • North Mississippi Medical Center Hematology and Oncology Clinic

    Tupelo, Mississippi 38801
    United States

    Active - Recruiting

  • MidAmerica Division Inc., c/o Research Medical Center

    Kansas City, Missouri 64132
    United States

    Active - Recruiting

  • Research site

    Kansas City, Missouri 64132
    United States

    Active - Recruiting

  • Saint Luke's Hospital Cancer Institute

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Lake Regional

    Osage Beach, Missouri 65065
    United States

    Active - Recruiting

  • Oncology Hematology Associates

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Research site

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Research site

    Billings, Montana 59102
    United States

    Active - Recruiting

  • St. Vincent Frontier Cancer Center

    Billings, Montana 59102
    United States

    Active - Recruiting

  • Cancer Partners of Nebraska

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68106
    United States

    Active - Recruiting

  • Renown Health

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Research site

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • Research site

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • Summit Medical Group

    Florham Park, New Jersey 07932
    United States

    Site Not Available

  • Regional Cancer Care Associates LLC RCCA

    Freehold, New Jersey 03756
    United States

    Active - Recruiting

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Active - Recruiting

  • CHRISTUS St. Vincent

    Santa Fe, New Mexico 87505
    United States

    Active - Recruiting

  • Elmhurst (BRANY site)

    Elmhurst, New York 11373
    United States

    Active - Recruiting

  • Northwell Health

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Stony Brook Cancer Center

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Great Lakes Cancer Care (Kaleida Health)

    Williamsville, New York 14221
    United States

    Active - Recruiting

  • Summa Health

    Akron, Ohio 44304
    United States

    Active - Recruiting

  • Aultman Cancer Center

    Canton, Ohio 44710
    United States

    Active - Recruiting

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio 44708
    United States

    Active - Recruiting

  • Gabrail Cancer Center (GCC) Research- Canton Facility

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Research site

    Canton, Ohio 44708
    United States

    Active - Recruiting

  • MetroHealth

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Research site

    Massillon, Ohio 44646
    United States

    Active - Recruiting

  • Tricounty Hematology and Oncology Associates

    Massillon, Ohio 44646
    United States

    Active - Recruiting

  • Research site

    Toledo, Ohio 43623
    United States

    Active - Recruiting

  • The Toledo Clinic

    Toledo, Ohio 43623
    United States

    Site Not Available

  • CharterCARE (Roger Williams)

    Providence, Rhode Island 02908
    United States

    Active - Recruiting

  • Monument Health

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • CHRISTUS Institute for Innovation & Advanced Clinical Care

    Corpus Christi, Texas 78404
    United States

    Active - Recruiting

  • DHR Research

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • Research site

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Research site

    Harlingen, Texas 78550
    United States

    Active - Recruiting

  • Valley Cancer Associates

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Millennium Research and Clinical Development

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Research site

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Lumi Research

    Kingwood, Texas 77339
    United States

    Active - Recruiting

  • Research site

    Kingwood, Texas 77339
    United States

    Active - Recruiting

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas 79410
    United States

    Active - Recruiting

  • Research site

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Tyler/HOPE Cancer Center

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • Utah Cancer Specialists

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Utah Cancer Specialists

    Salt Lake City, Utah 84106
    United States

    Active - Recruiting

  • American Oncology Network Vista Oncology Division

    Olympia, Washington 98502
    United States

    Active - Recruiting

  • Research site

    Olympia, Washington 98502
    United States

    Active - Recruiting

  • Medical Oncology Associates, PS (dba Summit Cancer Centers)

    Spokane Valley, Washington 99216
    United States

    Active - Recruiting

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington 98405
    United States

    Active - Recruiting

  • Research site

    Tacoma, Washington 98405
    United States

    Active - Recruiting

  • West Virginia University Cancer Institute

    Morgantown, West Virginia 26505
    United States

    Active - Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • Froedtert Hospital- Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.