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

October 20, 2025 updated by: Shanghai Henlius Biotech

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)

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35223
        • Alabama Oncology
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • City of Hope - Phoenix
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center (ACRC)
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group
    • California
      • Fountain Valley, California, United States, 92708
        • Compassionate Care Research Group
      • Fullerton, California, United States, 92835
        • Providence Medical Foundation
      • Glendale, California, United States, 91204
        • Los Angeles Cancer Network
      • Los Alamitos, California, United States, 90720
        • OPN - Oncology Physician Network
      • Los Angeles, California, United States, 90034
        • Kaiser Permanente Research (Southern California)
      • Sacramento, California, United States, 95817
        • UC Davis
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • UCHealth Memorial Hospital North
      • Greeley, Colorado, United States, 80631
        • Banner MD Anderson Cancer Center (BMDACC)
      • Greeley, Colorado, United States, 80631
        • MD Anderson- North Colorado Medical Center
    • Florida
      • Brooksville, Florida, United States, 34613
        • Advanced Cancer Treatment Centers
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists North Florida
      • Miami, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Ocala, Florida, United States, 34473
        • Florida Cancer Affiliates- (Ocala Oncology - Main)
      • Orange City, Florida, United States, 32763
        • Mid Florida Hematology and Oncology Center
      • Plantation, Florida, United States, 33322
        • BRCR Global
      • Pompano Beach, Florida, United States, 33064
        • NAPA Research
      • Tamarac, Florida, United States, 33321
        • Advanced Research
    • Illinois
      • Chicago, Illinois, United States, 60099
        • City of Hope- Chicago
      • Decatur, Illinois, United States, 62526
        • Cancer Center of Decatur
      • Tinley Park, Illinois, United States, 60487
        • Accellacare of Duly
    • Indiana
      • Dyer, Indiana, United States, 46311
        • Northwest Cancer Centers
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Pikeville, Kentucky, United States, 41501
        • Pikeville Hospital
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • CHRISTUS St. Frances Cabrini Cancer Center
      • Hammond, Louisiana, United States, 70433
        • Pontchartrain Cancer Center
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Henry Ford Health Providence Southfield Hospital
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Health Partners Cancer Center at Regions Hospital
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic Hematology/Oncology
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center Hematology and Oncology Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • MidAmerica Division Inc., c/o Research Medical Center
      • Osage Beach, Missouri, United States, 65065
        • Lake Regional
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Frontier Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • University of Nebraska Medical Center
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Health
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Freehold, New Jersey, United States, 03756
        • Regional Cancer Care Associates LLC RCCA
      • Neptune City, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
    • New York
      • Elmhurst, New York, United States, 11373
        • Elmhurst (BRANY site)
      • Lake Success, New York, United States, 11042
        • Northwell Health
      • Stony Brook, New York, United States, 11794
        • Stony Brook Cancer Center
      • Williamsville, New York, United States, 14221
        • Great Lakes Cancer Care (Kaleida Health)
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health
      • Canton, Ohio, United States, 44708
        • Cleveland Clinic Mercy Hospital
      • Canton, Ohio, United States, 44710
        • Aultman Cancer Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Massillon, Ohio, United States, 44646
        • Tricounty Hematology and Oncology Associates
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • CharterCARE (Roger Williams)
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Monument Health
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • CHRISTUS Institute for Innovation & Advanced Clinical Care
      • Edinburg, Texas, United States, 78539
        • DHR Research
      • Houston, Texas, United States, 77090
        • Millennium Research and Clinical Development
      • Kingwood, Texas, United States, 77339
        • Lumi Research
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Research and Treatment Center
      • Tyler, Texas, United States, 75701
        • The University of Texas Health Science Center at Tyler/HOPE Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Washington
      • Olympia, Washington, United States, 98502
        • American Oncology Network Vista Oncology Division
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • West Virginia University Cancer Institute
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital- Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atezolizumab + chemotherapy
Atezolizumab + chemotherapy (carboplatin-etoposide)
Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)

Drug: Atezolizumab is a monoclonal antibody targeting PD-L1，developed by Roche Pharma AG.

Drug: carboplatin and etoposide chemotherapeutics
Experimental: Serplulimab + chemotherapy
Serplulimab + chemotherapy (carboplatin-etoposide)
Drug: Serplulimab + chemotherapy (carboplatin-etoposide)

Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

Drug: carboplatin and etoposide chemotherapeutics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: A period from randomization through death regardless of causality (approximately up to 24 months).
Overall assessment
A period from randomization through death regardless of causality (approximately up to 24 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: approximately up to 14 months
Objective response rate
approximately up to 14 months
PFS
Time Frame: approximately up to 24 months
Progression-free survival
approximately up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: approximately up to 24 months
Adverse events are described and graded using the grading categories defined in CTCAE, Version 5.0
approximately up to 24 months
Maximum Plasma Concentration (Cmax)
Time Frame: approximately up to 24 months
The maximum concentration (Cmax) of Serplulimab will be measured
approximately up to 24 months
Minimum Plasma Concentration (Cmin)
Time Frame: approximately up to 24 months
The minimum concentration (Cmin) of Serplulimab will be measured
approximately up to 24 months
Average Plasma Concentration (Cavg)
Time Frame: approximately up to 24 months
The average Plasma Concentration (Cavg) of Serplulimab will be measured
approximately up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Henlius Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2022

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (Actual)

July 21, 2022

Study Record Updates

Last Update Posted (Estimated)

October 21, 2025

Last Update Submitted That Met QC Criteria

October 20, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASTRIDE (HLX10-005-SCLC301-E)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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