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

Last updated: October 20, 2025
Sponsor: Shanghai Henlius Biotech
Overall Status: Active - Not Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Treatment

Atezolizumab + chemotherapy (carboplatin-etoposide)

Serplulimab + chemotherapy (carboplatin-etoposide)

HLX10 + 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: Atezolizumab + chemotherapy (carboplatin-etoposide)
Phase: 3
Study Start date:
November 18, 2022
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Alabama Oncology

    Birmingham, Alabama 35223
    United States

    Site Not Available

  • O'Neal Comprehensive Cancer Center

    Birmingham, Alabama 352942
    United States

    Site Not Available

  • Alabama Oncology

    Birmingham 4049979, Alabama 4829764 35223
    United States

    Site Not Available

  • City of Hope - Phoenix

    Goodyear, Arizona 85338
    United States

    Site Not Available

  • Research site

    Goodyear, Arizona 85338
    United States

    Active - Recruiting

  • Arizona Clinical Research Center (ACRC)

    Tucson, Arizona 85715
    United States

    Site Not Available

  • City of Hope - Phoenix

    Goodyear 5296266, Arizona 5551752 85338
    United States

    Site Not Available

  • Arizona Clinical Research Center (ACRC)

    Tucson 5318313, Arizona 5551752 85715
    United States

    Site Not Available

  • Highland Spring Group

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • Research site

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • Highlands Oncology Group

    Springdale 4132093, Arkansas 4099753 72762
    United States

    Site Not Available

  • OPN - Oncology Physician Network

    Arcadia, California 91107
    United States

    Site Not Available

  • Research site

    Arcadia, California 91107
    United States

    Active - Recruiting

  • Compassionate Care Research Group

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Research site

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Fullerton, California 92835
    United States

    Site Not Available

  • Los Angeles Cancer Network

    Glendale, California 91204
    United States

    Site Not Available

  • Long Beach Memorial Medical Center

    Long Beach, California 90806
    United States

    Site Not Available

  • Research site

    Long Beach, California 90806
    United States

    Active - Recruiting

  • OPN - Oncology Physician Network

    Los Alamitos, California 90720
    United States

    Site Not Available

  • 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

    Site Not Available

  • Providence Medical Group

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Research site

    Santa Rosa, California 90027
    United States

    Active - Recruiting

  • Compassionate Care Research Group

    Fountain Valley 5350207, California 5332921 92708
    United States

    Site Not Available

  • Providence Medical Foundation

    Fullerton 5351247, California 5332921 92835
    United States

    Site Not Available

  • Los Angeles Cancer Network

    Glendale 5352423, California 5332921 91204
    United States

    Site Not Available

  • OPN - Oncology Physician Network

    Los Alamitos 5368304, California 5332921 90720
    United States

    Site Not Available

  • Kaiser Permanente Research (Southern California)

    Los Angeles 5368361, California 5332921 90034
    United States

    Site Not Available

  • UC Davis

    Sacramento 5389489, California 5332921 95817
    United States

    Site Not Available

  • UCHealth Memorial Hospital North

    Colorado Springs, Colorado 80920
    United States

    Site Not Available

  • 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

    Site Not Available

  • MD Anderson- North Colorado Medical Center

    Greeley, Colorado 80631
    United States

    Active - Recruiting

  • UCHealth Memorial Hospital North

    Colorado Springs 5417598, Colorado 5417618 80920
    United States

    Site Not Available

  • Banner MD Anderson Cancer Center (BMDACC)

    Greeley 5577592, Colorado 5417618 80631
    United States

    Site Not Available

  • MD Anderson- North Colorado Medical Center

    Greeley 5577592, Colorado 5417618 80631
    United States

    Site Not Available

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • 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

    Site Not Available

  • Clermont Oncology Center

    Clermont, Florida 34711
    United States

    Site Not Available

  • Cancer Specialists North Florida

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Mount Sinai Comprehensive Cancer Center

    Miami, Florida 33140
    United States

    Site Not Available

  • 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

    Site Not Available

  • Research site

    Ocala, Florida 34473
    United States

    Active - Recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Site Not Available

  • Research site

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • BRCR Global

    Plantation, Florida 33322
    United States

    Site Not Available

  • Research site

    Plantation, Florida 33322
    United States

    Active - Recruiting

  • Napa Research

    Pompano Beach, Florida 33064
    United States

    Site Not Available

  • Research site

    Pompano Beach, Florida 33064
    United States

    Active - Recruiting

  • Advanced Research

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Research site

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Advanced Cancer Treatment Centers

    Brooksville 4148986, Florida 4155751 34613
    United States

    Site Not Available

  • Cancer Specialists North Florida

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Site Not Available

  • Mount Sinai Comprehensive Cancer Center

    Miami 4164138, Florida 4155751 33140
    United States

    Site Not Available

  • Florida Cancer Affiliates- (Ocala Oncology - Main)

    Ocala 4166673, Florida 4155751 34473
    United States

    Site Not Available

  • Mid Florida Hematology and Oncology Center

    Orange City 4167055, Florida 4155751 32763
    United States

    Site Not Available

  • BRCR Global

    Plantation 4168782, Florida 4155751 33322
    United States

    Site Not Available

  • Napa Research

    Pompano Beach 4169014, Florida 4155751 33064
    United States

    Site Not Available

  • Advanced Research

    Tamarac 4174738, Florida 4155751 33321
    United States

    Site Not Available

  • City of Hope- Chicago

    Chicago, Illinois 60099
    United States

    Site Not Available

  • Research site

    Chicago, Illinois 60099
    United States

    Active - Recruiting

  • Cancer Center of Decatur

    Decatur, Illinois 62526
    United States

    Site Not Available

  • 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

    Site Not Available

  • City of Hope- Chicago

    Chicago 4887398, Illinois 4896861 60099
    United States

    Site Not Available

  • Cancer Center of Decatur

    Decatur 4236895, Illinois 4896861 62526
    United States

    Site Not Available

  • Accellacare of Duly

    Tinley Park 4913723, Illinois 4896861 60487
    United States

    Site Not Available

  • Northwest Cancer Centers

    Dyer, Indiana 46311
    United States

    Site Not Available

  • Northwest Cancer Centers

    Dyer 4919820, Indiana 4921868 46311
    United States

    Site Not Available

  • Cancer Center of Kansas

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer Center of Kansas

    Wichita 4281730, Kansas 4273857 67214
    United States

    Site Not Available

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • 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

    Site Not Available

  • Baptist Health Lexington

    Lexington 4297983, Kentucky 6254925 40503
    United States

    Site Not Available

  • Pikeville Hospital

    Pikeville 4304232, Kentucky 6254925 41501
    United States

    Site Not Available

  • CHRISTUS St. Frances Cabrini Cancer Center

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Pontchartrain Cancer Center

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Research site

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Pontchartrain Cancer Center

    Hammond, Louisiana 70433
    United States

    Site Not Available

  • 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

    Site Not Available

  • CHRISTUS St. Frances Cabrini Cancer Center

    Alexandria 4314550, Louisiana 4331987 71301
    United States

    Site Not Available

  • Pontchartrain Cancer Center

    Hammond 4326868, Louisiana 4331987 70433
    United States

    Site Not Available

  • 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

    Site Not Available

  • Lahey Hospital & Medical Center

    Burlington 4931737, Massachusetts 6254926 01805
    United States

    Site Not Available

  • 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

    Site Not Available

  • Henry Ford Health Providence Southfield Hospital

    Southfield 5010636, Michigan 5001836 48075
    United States

    Site Not Available

  • Health Partners Cancer Center at Regions Hospital

    Saint Paul, Minnesota 55101
    United States

    Site Not Available

  • Health Partners Cancer Center at Regions Hospital

    Saint Paul 5045360, Minnesota 5037779 55101
    United States

    Site Not Available

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • North Mississippi Medical Center Hematology and Oncology Clinic

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg 4429295, Mississippi 4436296 39401
    United States

    Site Not Available

  • North Mississippi Medical Center Hematology and Oncology Clinic

    Tupelo 4448903, Mississippi 4436296 38801
    United States

    Site Not Available

  • 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

    Site Not Available

  • Oncology Hematology Associates

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Research site

    Springfield, Missouri 65807
    United States

    Active - Recruiting

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

    Kansas City 4393217, Missouri 4398678 64132
    United States

    Site Not Available

  • Lake Regional

    Osage Beach 4402040, Missouri 4398678 65065
    United States

    Site Not Available

  • Research site

    Billings, Montana 59102
    United States

    Active - Recruiting

  • St. Vincent Frontier Cancer Center

    Billings, Montana 59102
    United States

    Site Not Available

  • St. Vincent Frontier Cancer Center

    Billings 5640350, Montana 5667009 59102
    United States

    Site Not Available

  • 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

    Site Not Available

  • University of Nebraska Medical Center

    Omaha 5074472, Nebraska 5073708 68106
    United States

    Site Not Available

  • Renown Health

    Reno, Nevada 89502
    United States

    Site Not Available

  • Research site

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Renown Health

    Reno 5511077, Nevada 5509151 89502
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Research site

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Site Not Available

  • 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

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Regional Cancer Care Associates LLC RCCA

    Freehold 5098278, New Jersey 5101760 03756
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune City 5101687, New Jersey 5101760 07753
    United States

    Site Not Available

  • CHRISTUS St. Vincent

    Santa Fe, New Mexico 87505
    United States

    Site Not Available

  • Elmhurst (BRANY site)

    Elmhurst, New York 11373
    United States

    Site Not Available

  • Northwell Health

    Lake Success, New York 11042
    United States

    Site Not Available

  • Stony Brook Cancer Center

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Great Lakes Cancer Care (Kaleida Health)

    Williamsville, New York 14221
    United States

    Site Not Available

  • Elmhurst (BRANY site)

    Elmhurst 5116495, New York 5128638 11373
    United States

    Site Not Available

  • Northwell Health

    Lake Success 5123853, New York 5128638 11042
    United States

    Site Not Available

  • Stony Brook Cancer Center

    Stony Brook 5139865, New York 5128638 11794
    United States

    Site Not Available

  • Great Lakes Cancer Care (Kaleida Health)

    Williamsville 5144588, New York 5128638 14221
    United States

    Site Not Available

  • Summa Health

    Akron, Ohio 44304
    United States

    Site Not Available

  • 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

    Site Not Available

  • Research site

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • MetroHealth

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • 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

    Site Not Available

  • Research site

    Toledo, Ohio 43623
    United States

    Active - Recruiting

  • The Toledo Clinic

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Summa Health

    Akron 5145476, Ohio 5165418 44304
    United States

    Site Not Available

  • Aultman Cancer Center

    Canton 5149222, Ohio 5165418 44710
    United States

    Site Not Available

  • Cleveland Clinic Mercy Hospital

    Canton 5149222, Ohio 5165418 44708
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Tricounty Hematology and Oncology Associates

    Massillon 5162097, Ohio 5165418 44646
    United States

    Site Not Available

  • CharterCARE (Roger Williams)

    Providence, Rhode Island 02908
    United States

    Site Not Available

  • CharterCARE (Roger Williams)

    Providence 5224151, Rhode Island 5224323 02908
    United States

    Site Not Available

  • Monument Health

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Monument Health

    Rapid City 5768233, South Dakota 5769223 57701
    United States

    Site Not Available

  • CHRISTUS Institute for Innovation & Advanced Clinical Care

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • DHR Research

    Edinburg, Texas 78539
    United States

    Site Not Available

  • 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

    Site Not Available

  • Research site

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Lumi Research

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Research site

    Kingwood, Texas 77339
    United States

    Active - Recruiting

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas 79410
    United States

    Site Not Available

  • 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

    Site Not Available

  • CHRISTUS Institute for Innovation & Advanced Clinical Care

    Corpus Christi 4683416, Texas 4736286 78404
    United States

    Site Not Available

  • DHR Research

    Edinburg 4688275, Texas 4736286 78539
    United States

    Site Not Available

  • Millennium Research and Clinical Development

    Houston 4699066, Texas 4736286 77090
    United States

    Site Not Available

  • Lumi Research

    Kingwood 7534469, Texas 4736286 77339
    United States

    Site Not Available

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock 5525577, Texas 4736286 79410
    United States

    Site Not Available

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

    Tyler 4738214, Texas 4736286 75701
    United States

    Site Not Available

  • Utah Cancer Specialists

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Utah Cancer Specialists

    Salt Lake City, Utah 84106
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

  • Utah Cancer Specialists

    Salt Lake City 5780993, Utah 5549030 84106
    United States

    Site Not Available

  • American Oncology Network Vista Oncology Division

    Olympia, Washington 98502
    United States

    Site Not Available

  • Research site

    Olympia, Washington 98502
    United States

    Active - Recruiting

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

    Spokane Valley, Washington 99216
    United States

    Site Not Available

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Research site

    Tacoma, Washington 98405
    United States

    Active - Recruiting

  • American Oncology Network Vista Oncology Division

    Olympia 5805687, Washington 5815135 98502
    United States

    Site Not Available

  • Northwest Medical Specialties, PLLC

    Tacoma 5812944, Washington 5815135 98405
    United States

    Site Not Available

  • West Virginia University Cancer Institute

    Morgantown, West Virginia 26505
    United States

    Site Not Available

  • West Virginia University Cancer Institute

    Morgantown 4815352, West Virginia 4826850 26505
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Froedtert Hospital- Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Site Not Available

  • Froedtert Hospital- Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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