To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
Launched by SHANGHAI HENLIUS BIOTECH · Jul 19, 2022
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the combination of a new treatment called Serplulimab with standard chemotherapy (Carboplatin and Etoposide) for patients with extensive stage small cell lung cancer (ES-SCLC). The goal is to compare how effective and safe this new combination is against another treatment option, Atezolizumab with the same chemotherapy, in patients who have not received treatment for their cancer before.
To participate in this study, you need to be at least 18 years old and have a confirmed diagnosis of ES-SCLC without having received any previous treatment. Other requirements include having at least one measurable tumor and good overall health. If you join the trial, you will be randomly assigned to receive either the Serplulimab treatment or the Atezolizumab treatment. The trial is currently recruiting participants, and it’s important to note that if you are pregnant, breastfeeding, or have certain health conditions, you may not qualify. Overall, this trial aims to find better treatment options for people facing this challenging type of cancer.
Gender
ALL
Eligibility criteria
- 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.
About Shanghai Henlius Biotech
Shanghai Henlius Biotech, Inc. is a leading biopharmaceutical company based in Shanghai, China, specializing in the research, development, and commercialization of innovative monoclonal antibodies and biosimilars. With a strong focus on oncology and autoimmune diseases, Henlius leverages advanced biotechnological platforms to create effective therapeutic solutions that enhance patient outcomes. The company is committed to high standards of quality and compliance in clinical trials, driven by a mission to improve global healthcare through accessible and affordable biologic therapies. Henlius operates with a robust pipeline of products in various stages of development, aiming to make significant contributions to the evolving landscape of biopharmaceuticals.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lebanon, New Hampshire, United States
Canton, Ohio, United States
Long Beach, California, United States
Salt Lake City, Utah, United States
Lubbock, Texas, United States
Norwich, Connecticut, United States
Omaha, Nebraska, United States
Miami, Florida, United States
Omaha, Nebraska, United States
Madison, Wisconsin, United States
Tacoma, Washington, United States
Fort Worth, Texas, United States
Salt Lake City, Utah, United States
Canton, Ohio, United States
Wichita, Kansas, United States
Fountain Valley, California, United States
Reno, Nevada, United States
New Orleans, Louisiana, United States
Lexington, Kentucky, United States
Sacramento, California, United States
Long Beach, California, United States
Tacoma, Washington, United States
Evanston, Illinois, United States
Bethesda, Maryland, United States
Los Alamitos, California, United States
Shreveport, Louisiana, United States
Neptune, New Jersey, United States
Tamarac, Florida, United States
Covington, Louisiana, United States
Lebanon, New Hampshire, United States
Akron, Ohio, United States
Los Angeles, California, United States
Cleveland, Ohio, United States
Billings, Montana, United States
Toledo, Ohio, United States
Springfield, Missouri, United States
Houston, Texas, United States
Cleveland, Ohio, United States
Orange City, Florida, United States
Kansas City, Missouri, United States
Stamford, Connecticut, United States
New Orleans, Louisiana, United States
Massillon, Ohio, United States
Fort Worth, Texas, United States
Harlingen, Texas, United States
Tyler, Texas, United States
Burlington, Massachusetts, United States
Canton, Ohio, United States
Pasadena, California, United States
Stamford, Connecticut, United States
Harlingen, Texas, United States
Springdale, Arkansas, United States
Stamford, Connecticut, United States
Kingwood, Texas, United States
Olympia, Washington, United States
Hattiesburg, Mississippi, United States
Billings, Montana, United States
Golden, Colorado, United States
Stony Brook, New York, United States
Goodyear, Arizona, United States
Miami, Florida, United States
Plantation, Florida, United States
Fountain Valley, California, United States
Lake Success, New York, United States
Springdale, Arkansas, United States
Tupelo, Mississippi, United States
Covington, Louisiana, United States
Orange City, Florida, United States
Bethesda, Maryland, United States
Los Angeles, California, United States
Toledo, Ohio, United States
Florham Park, New Jersey, United States
Birmingham, Alabama, United States
Denver, Colorado, United States
Springfield, Missouri, United States
Plantation, Florida, United States
Reno, Nevada, United States
Fullerton, California, United States
Rapid City, South Dakota, United States
Tamarac, Florida, United States
Colorado Springs, Colorado, United States
Pompano Beach, Florida, United States
Pompano Beach, Florida, United States
Bountiful, Utah, United States
Spokane Valley, Washington, United States
Kingwood, Texas, United States
Rolling Meadows, Illinois, United States
Rogers, Arkansas, United States
Houston, Texas, United States
Massillon, Ohio, United States
Clermont, Florida, United States
Santa Rosa, California, United States
Lincoln, Nebraska, United States
Houston, Texas, United States
Santa Fe, New Mexico, United States
Arcadia, California, United States
Santa Rosa, California, United States
Ocala, Florida, United States
Chicago, Illinois, United States
Hammond, Louisiana, United States
Miami, Florida, United States
Goodyear, Arizona, United States
Arcadia, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Santa Rosa, California, United States
Golden, Colorado, United States
Brooksville, Florida, United States
Ocala, Florida, United States
Chicago, Illinois, United States
Hammond, Louisiana, United States
Southfield, Michigan, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Elmhurst, New York, United States
Canton, Ohio, United States
Corpus Christi, Texas, United States
Edinburg, Texas, United States
Tyler, Texas, United States
Olympia, Washington, United States
Osage Beach, Missouri, United States
Chicago, Illinois, United States
Alexandria, Louisiana, United States
Baltimore, Maryland, United States
Williamsville, New York, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Decatur, Illinois, United States
Freehold, New Jersey, United States
Birmingham, Alabama, United States
Glendale, California, United States
Tinley Park, Illinois, United States
Providence, Rhode Island, United States
Greeley, Colorado, United States
Jacksonville, Florida, United States
Dyer, Indiana, United States
Kansas City, Missouri, United States
Southfield, Michigan, United States
Tucson, Arizona, United States
Greeley, Colorado, United States
Louisville, Kentucky, United States
Pikeville, Kentucky, United States
Boston, Massachusetts, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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