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

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

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)

NCT05468489•Shanghai Henlius Biotech

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.

Locations (67)

Alabama Oncology

Birmingham, Alabama, United States

City of Hope - Phoenix

Goodyear, Arizona, United States

Arizona Clinical Research Center (ACRC)

Tucson, Arizona, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Compassionate Care Research Group

Fountain Valley, California, United States

Providence Medical Foundation

Fullerton, California, United States

Los Angeles Cancer Network

Glendale, California, United States

OPN - Oncology Physician Network

Los Alamitos, California, United States

Kaiser Permanente Research (Southern California)

Los Angeles, California, United States

UC Davis

Sacramento, California, United States

Key Dates

Start Date

November 18, 2022

Primary Completion Date

February 28, 2026

Completion Date

December 31, 2027

Last Updated

October 21, 2025

Enrollment

200

ESTIMATED participants

Conditions

Extensive Stage Small Cell Lung Cancer

Interventions

Serplulimab + chemotherapy (carboplatin-etoposide)

DRUG

Atezolizumab + chemotherapy (carboplatin-etoposide)

DRUG

A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

NCT07037758

Extensive Stage Small Cell Lung Cancer

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NCT05055999

Extensive Stage Small Cell Lung Cancer

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COMPLETEDNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Tumor Microenvironment Surveillance on Simultaneous Liver Metastases Extensive Stage Small Cell Lung Cancer

Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

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