Active Not RecruitingPhase 3NCT05468489
Official study title

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

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)

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSerplulimab + chemotherapy (carboplatin-etoposide) and Atezolizumab + chemotherapy (carboplatin-etoposide)

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 21, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?67 U.S. locations

Locations may change over time.

Who runs it?Shanghai Henlius Biotech

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Shanghai Henlius Biotech
Interventions being studied
Drug: Serplulimab + chemotherapy (carboplatin-etoposide); Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Alabama OncologyBirmingham, Alabama
  • City of Hope - PhoenixGoodyear, Arizona
  • Arizona Clinical Research Center (ACRC)Tucson, Arizona
  • Highlands Oncology GroupSpringdale, Arkansas
  • Compassionate Care Research GroupFountain Valley, California
  • Providence Medical FoundationFullerton, California
  • Los Angeles Cancer NetworkGlendale, California
  • OPN - Oncology Physician NetworkLos Alamitos, California
  • Kaiser Permanente Research (Southern California)Los Angeles, California
  • UC DavisSacramento, California
  • UCHealth Memorial Hospital NorthColorado Springs, Colorado
  • Banner MD Anderson Cancer Center (BMDACC)Greeley, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 21, 2025. Always confirm current availability with the study team.

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