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

NCT05468489 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: ASTRIDE (HLX10-005-SCLC301-E)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 67

Brief 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)

Conditions

Extensive Stage Small Cell Lung Cancer

Keywords

Extensive Stage Small Cell Lung Cancer; Anti-PD-1 Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

• OS

  Overall assessment

  A period from randomization through death regardless of causality (approximately up to 24 months).

Secondary Outcomes (6)

• ORR

  approximately up to 14 months

• PFS

  approximately up to 24 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  approximately up to 24 months

• Maximum Plasma Concentration (Cmax)

  approximately up to 24 months

• Minimum Plasma Concentration (Cmin)

  approximately up to 24 months

Study Arms (2)

Serplulimab + chemotherapy

EXPERIMENTAL

Serplulimab + chemotherapy (carboplatin-etoposide)

Drug: Serplulimab + chemotherapy (carboplatin-etoposide)

Atezolizumab + chemotherapy

ACTIVE COMPARATOR

Atezolizumab + chemotherapy (carboplatin-etoposide)

Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)

Interventions

Serplulimab + chemotherapy (carboplatin-etoposide) DRUG

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

Serplulimab + chemotherapy

Atezolizumab + chemotherapy (carboplatin-etoposide) DRUG

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

Atezolizumab + chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (67)

Alabama Oncology

Birmingham, Alabama, 35223, United States

Location

City of Hope - Phoenix

Goodyear, Arizona, 85338, United States

Location

Arizona Clinical Research Center (ACRC)

Tucson, Arizona, 85715, United States

Location

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

Location

Compassionate Care Research Group

Fountain Valley, California, 92708, United States

Location

Providence Medical Foundation

Fullerton, California, 92835, United States

Location

Los Angeles Cancer Network

Glendale, California, 91204, United States

Location

OPN - Oncology Physician Network

Los Alamitos, California, 90720, United States

Location

Kaiser Permanente Research (Southern California)

Los Angeles, California, 90034, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

UCHealth Memorial Hospital North

Colorado Springs, Colorado, 80920, United States

Location

Banner MD Anderson Cancer Center (BMDACC)

Greeley, Colorado, 80631, United States

Location

MD Anderson- North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Advanced Cancer Treatment Centers

Brooksville, Florida, 34613, United States

Location

Cancer Specialists North Florida

Jacksonville, Florida, 32256, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami, Florida, 33140, United States

Location

Florida Cancer Affiliates- (Ocala Oncology - Main)

Ocala, Florida, 34473, United States

Location

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

Location

BRCR Global

Plantation, Florida, 33322, United States

Location

Napa Research

Pompano Beach, Florida, 33064, United States

Location

Advanced Research

Tamarac, Florida, 33321, United States

Location

City of Hope- Chicago

Chicago, Illinois, 60099, United States

Location

Cancer Center of Decatur

Decatur, Illinois, 62526, United States

Location

Accellacare of Duly

Tinley Park, Illinois, 60487, United States

Location

Northwest Cancer Centers

Dyer, Indiana, 46311, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Pikeville Hospital

Pikeville, Kentucky, 41501, United States

Location

CHRISTUS St. Frances Cabrini Cancer Center

Alexandria, Louisiana, 71301, United States

Location

Pontchartrain Cancer Center

Hammond, Louisiana, 70433, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, 48075, United States

Location

Health Partners Cancer Center at Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, 39401, United States

Location

North Mississippi Medical Center Hematology and Oncology Clinic

Tupelo, Mississippi, 38801, United States

Location

MidAmerica Division Inc., c/o Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Lake Regional

Osage Beach, Missouri, 65065, United States

Location

St. Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68106, United States

Location

Renown Health

Reno, Nevada, 89502, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Regional Cancer Care Associates LLC RCCA

Freehold, New Jersey, 03756, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Elmhurst (BRANY site)

Elmhurst, New York, 11373, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

Location

Great Lakes Cancer Care (Kaleida Health)

Williamsville, New York, 14221, United States

Location

Summa Health

Akron, Ohio, 44304, United States

Location

Cleveland Clinic Mercy Hospital

Canton, Ohio, 44708, United States

Location

Aultman Cancer Center

Canton, Ohio, 44710, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Tricounty Hematology and Oncology Associates

Massillon, Ohio, 44646, United States

Location

CharterCARE (Roger Williams)

Providence, Rhode Island, 02908, United States

Location

Monument Health

Rapid City, South Dakota, 57701, United States

Location

CHRISTUS Institute for Innovation & Advanced Clinical Care

Corpus Christi, Texas, 78404, United States

Location

DHR Research

Edinburg, Texas, 78539, United States

Location

Millennium Research and Clinical Development

Houston, Texas, 77090, United States

Location

Lumi Research

Kingwood, Texas, 77339, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410, United States

Location

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

Tyler, Texas, 75701, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

American Oncology Network Vista Oncology Division

Olympia, Washington, 98502, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

West Virginia University Cancer Institute

Morgantown, West Virginia, 26505, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Froedtert Hospital- Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Interventions

Drug Therapy; EC regimen; atezolizumab

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 21, 2022
• Study Start: November 18, 2022
• Primary Completion: February 28, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (67)