Active Not RecruitingPhase 3NCT05468489

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

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)

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

StatusActive Not Recruiting
PhasePhase 3
U.S. locations67
SponsorShanghai Henlius Biotech
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

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.

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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