To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
Running, not enrolling · Phase 3
Conditions studied: Extensive Stage Small Cell Lung Cancer
In brief
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)
Key facts
- Study ID
- NCT05468489
- Run by
- Shanghai Henlius Biotech
- People needed
- 200
- Starts
- 2022-11-18
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-10-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- 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
- UCHealth Memorial Hospital North — Colorado Springs, Colorado, United States
- Banner MD Anderson Cancer Center (BMDACC) — Greeley, Colorado, United States
- MD Anderson- North Colorado Medical Center — Greeley, Colorado, United States
- Advanced Cancer Treatment Centers — Brooksville, Florida, United States
- Cancer Specialists North Florida — Jacksonville, Florida, United States
- Mount Sinai Comprehensive Cancer Center — Miami, Florida, United States
- Florida Cancer Affiliates- (Ocala Oncology - Main) — Ocala, Florida, United States
- Mid Florida Hematology and Oncology Center — Orange City, Florida, United States
- BRCR Global — Plantation, Florida, United States
- Napa Research — Pompano Beach, Florida, United States
- Advanced Research — Tamarac, Florida, United States
- City of Hope- Chicago — Chicago, Illinois, United States
- Cancer Center of Decatur — Decatur, Illinois, United States
- Accellacare of Duly — Tinley Park, Illinois, United States
- Northwest Cancer Centers — Dyer, Indiana, United States
- Alabama Oncology — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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