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
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)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.